BMT CTN Protocol Listing

• Protocol Short Name and Number: S2213, 2205
• Protocol Long Name: A Phase III, Randomized Study of Daratumumab, Cyclophosphamide, Bortezomib and Dexamethasone (Dara-VCD) Induction Followed by Autologous Stem Cell Transplant or Dara-VCD Consolidation and Daratumumab Maintenance in Patients with Newly Diagnosed AL Amyloidosi
• Key Personnel
• Study Chairs:
  • ​​Patrick Hagen, MD, MPH
  • Surbhi Sidana, MD
  • Terri Parker, MD
  • Brian Walker, BSc, PhD
• Protocol Champions:
  • ​​Anita D’Souza, MD [BMT CTN]
  • Heather Landau, MD [Alliance] 
  • Taxiarchis Kourelis, MD [ECOG-ACRIN]
• SWOG Protocol Coordinator: Sharon Palmer, spalmer@swog.org

Note: For the SWOG S2213 / BMT CTN 2205 study, the BMT CTN is endorsing the study and providing accrual credit. Centers participate via their NCTN group. BMT CTN Centers will receive both NCTN and BMT CTN accrual credits. The protocol may be accessed through the CTSU website: https://www.ctsu.org. For questions about the study and how to participate, contact the SWOG protocol coordinator, Sharon Palmer, spalmer@swog.org or the CTSU Help Desk at ctsucontact@westat.com or 1 888 823-5923.

• Protocol Short Name and Number: TransIT, 2202
• Protocol Long Name: A Phase III Randomized Trial Comparing Unrelated Donor BMT With IST for Newly Diagnosed Pediatric and Young Adult Patients With Severe Aplastic Anemia
• Key Personnel
  • ​​​BMT CTN # 2202 Co-Chair: David Williams, MD
  • BMT CTN # 2202 Co-Chair: Michael Pulsipher, MD
  • BMT CTN # 2202 Co-Chair: Bronwen Shaw, MD
  • BMT CTN # 2202 Protocol Coordinator(s): Kristi Wilmes (kwilmes@nmdp.org), Leah Cheng (leah.cheng@childrens.harvard.edu)
  • Additional Contacts: TransITStudy@nmdp.org
• Keywords: Severe Aplastic Anemia, SAA, Aplastic Anemia, AA, Pediatric, Immunosuppressive Therapy, IST, Unrelated, TransIT, Child, Children, Teen, Adolescent

Note: For the PTCTC NMD2201 / BMT CTN 2202 study, the BMT CTN is endorsing the study and providing accrual credit. Centers participate via CIBMTR. BMT CTN Centers will receive BMT CTN accrual credits. For questions about the study and how to participate or to access study materials, contact protocol coordinators and TransITStudy@nmdp.org

• Protocol Short Name and Number: S2114, 2201
• Protocol Long Name: A Randomized Phase II Trial of Consolidation Therapy Following CD19 CAR T-Cell Treatment For Relapsed/Refractory Large B-Cell Lymphoma or Grade IIIB Follicular Lymphoma
• Key Personnel
  • SWOG Chair: Brian Hess, hessbr@musc.edu
  • BMT CTN Chair: Mehdi Hamadani, mhamadani@mcw.edu
  • SWOG Coordinator: Katarina Gasic, kgasic@swog.org

Note: For the SWOG S2114 / BMT CTN 2201 study, the BMT CTN is endorsing the study and providing accrual credit. Centers participate via their NCTN group. BMT CTN Centers will receive both NCTN and BMT CTN accrual credits. The protocol may be accessed through the CTSU website: https://www.ctsu.org. For questions about the study and how to participate, contact the SWOG protocol coordinator, Katarina Gasic, kgasic@swog.org or the CTSU Help Desk at ctsucontact@westat.com or 1 888 823-5923.

• Protocol Short Name and Number: COVID-19 Vaccine, 2101
• Protocol Long Name: Prospective Observational Study of The Immunogenicity of Vaccines for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) after Autologous Hematopoietic Stem Cell Transplantation (HCT), Allogeneic HCT, and Chimeric Antigen Receptor T-Cell Therapy
• Study Plan v5.0 (PDF)
• Study Plan List of Changes from v4.0 to v5.0
• Study Plan Appendices (.zip)
• ICFs (.zip)
• FAQs v6.0 (PDF)
• CIBMTR Data Reporting Guidelines v1.0
• COVID Observational Study Vaccine Flyer Template v1.0
• Site Roster Template v3.0
• Research Sample Information Guide v6.0
• LabCorp PSC Appointment Form - Fillable v3.0
• Kit Order Form – Fillable
• CIBMTR SC21-07_BMT CTN 2101_Site_Training_Attestation_Log_v1.0.docx
• CIBMTR BMT CTN Vaccine Study Overview Slides with Recording 20210412
• BMT CTN 2101 PI Call Recording - August 25, 2021
• Key Personnel
  • BMT CTN # 2101 Co-Chair: Joshua Hill, MD
  • BMT CTN # 2101 Co-Chair: Miguel-Angel Perales, MD
  • BMT CTN # 2101 Co-Chair: Marcie Riches, MD, MS
  • BMT CTN # 2101 Protocol Officer: Mary Horowitz, MD, MS, MACP
  • BMT CTN # 2101 Protocol Coordinator: Megan Scott; bmtctn2101@emmes.com
• Keywords: Vaccine, Vaccination, COVID, SARS-CoV-2, Autologous Transplant, Auto Transplant, Auto, Allogeneic Transplant, Allo Transplant, Allo, CAR-T, CAR T, CART, Hematopoietic Cell Transplant, HCT, HSCT, Pediatric, Child, Children, Teen, Adolescent

• Protocol Short Name and Number: SR-aGVHD, 2002
• Protocol Long Name: A Phase 3, Randomized, Open-Label, Multicenter Study, to Compare T-Guard to Ruxolitinib for the Treatment of Patients with Grade III or IV Steroid-Refractory Acute Graft-Versus-Host Disease (SR-aGVHD)
• Protocol Synopsis (PDF)
• ICFs (PDF)
• FAQs (PDF)
• Key Personnel
  • BMT CTN # 2002 Co-Chair: John Levine, MD
  • BMT CTN # 2002 Co-Chair: Gabby Meyers, MD
  • BMT CTN # 2002 Co-Chair: Gérard Socié, MD
  • BMT CTN # 2002 Protocol Officer: Mehdi Hamadani, MD
  • BMT CTN # 2002 Protocol Coordinator: 2002DCC@emmes.com
• Keywords: Graft vs. Host Disease, GVHD, Graft versus Host Disease, T-Guard, TGuard, Ruxolitinib, Steroid Refractory, Steroid-Refractory, Anti-CD3/CD7 Immunotoxin, Xenikos, GVHD Treatment

• Protocol Short Name and Number: GRASP, 2001
• Study Website: Cure Sickle Cell Initiative
• Protocol Long Name: A Multi-Center, Phase 2 Gene Transfer Study Inducing Fetal Hemoglobin in Sickle Cell Disease
• Protocol (PDF)
• ICFs (PDF)
• FAQs (PDF)
• Key Personnel
  • BMT CTN # 2001 Co-Chair: David Williams, MD
  • BMT CTN # 2001 Co-Chair: Mark Walters, MD
  • BMT CTN # 2001 Protocol Officer: Mary Eapen, MD
  • BMT CTN # 2001 Clinical Study Manager: DJ White; bmtctn2001@emmes.com
• Keywords: Sickle Cell Disease, SCD, Gene Therapy, Gene Transfer, Hematopoietic Stem Cell, HSC, Pediatric, Child, Children, Teen, Adolescent

• Protocol Short Name and Number: BEAT-MS, 1905
• Protocol Long Name: A Multicenter Randomized Controlled Trial of Best Available Therapy versus Autologous Hematopoietic Stem Cell Transplant for Treatment-Resistant Relapsing
• Key Personnel​​​​
  • BMT CTN 1905 Co-Chair: Jeffrey A. Cohen, MD
  • BMT CTN 1905 Co-Chair: George E. Georges, MD
  • BMT CTN 1905 Co-Chair: Paolo A. Muraro, MD, PhD
  • BMT CTN 1905 Chair: Marcelo Pasquini, MD; mpasquini@mcw.edu
  • NIAID Protocol Coordinator: Sean McCarthy, RN, MS; sean.mccarthy@nih.gov
  • BMT CTN DCC Coordinator: Amy Foley; afoley@nmdp.org
• Keywords: Multiple Sclerosis, MS, Autologous Transplant, Auto Transplant, Auto

Note: For the ITN077AI / BMT CTN 1905 study, the BMT CTN is endorsing the study and providing accrual credit. Centers participate via NIAID/Immune Tolerance Network (ITN). BMT CTN Centers will receive both NIAID/ITN and BMT CTN accrual credits. For questions about the study and how to participate or to access study materials, contact the NIAID protocol coordinator, Sean McCarthy, at sean.mccarthy@nih.gov.

• Protocol Short Name and Number: Treo for BMFD, 1904
• Protocol Long Name: Hematopoietic Cell Transplantation Using Treosulfan-Based Conditioning for the Treatment of Bone Marrow Failure Diseases
• Protocol Synopsis and/or Protocol (PDF)
• ICFs (PDF)
• FAQs (PDF)
• Key Personnel
  • BMT CTN # 1904 Co-Chair: Lauri Burroughs, MD
  • BMT CTN # 1904 Co-Chair: Margaret MacMillan, MD, MSc
  • BMT CTN # 1904 Protocol Officer: Mehdi Hamadani, MD
  • BMT CTN # 1904 Protocol Coordinator: Megan Scott; bmtctn1904@emmes.com
• Keywords: Treosulfan, Bone Marrow Failure Disease, BMFD, Diamond Blackfan Anemia, DBA, Shwachman-Diamond Syndrome, SDS, Congenital Sideroblastic anemia, CSA, GATA2, SAMD9, SAMD9L, Bone Marrow Failure, Marrow Failure, Congenital amegakaryocytic thrombocytopenia, Paroxysmal nocturnal hemoglobinuria, PNH, Hematopoietic Cell Transplant, HCT, HSCT, Allogeneic Transplant, Allo Transplant, Allo, Unrelated, Unrelated Donor, Quality of Life, QOL, Patient Reported Outcomes, PROs, Pediatric, Child, Children, Teen, Adolescent

• Protocol Short Name and Number: HIV T-cell, 1903
• Protocol Long Name: (AMC-109) - Administration of HIV-specific T cells to HIV+ Patients Receiving High Dose Chemotherapy Followed by Autologous Stem Cell Rescue -Auto-RESIST
• Protocol (PDF)
• ICFs (PDF)
• FAQs (PDF)
• Key Personnel
  • BMT CTN # 1903 Co-Chair: Rich Ambinder, MD
  • BMT CTN # 1903 Co-Chair: Kieron Dunleavy, MD
  • BMT CTN # 1903 Protocol Officer: Steve Devine, MD
  • BMT CTN # 1903 Protocol Coordinator: Christine Borchert; bmtctn1903@emmes.com
• Keywords: HIV, Autologous Stem Cell Rescue, Autologous Stem Cell Transplant, ASCT, Auto, RESIST, Auto Transplant, Autologous Transplant, HST-NEETs, HSCT, HCT, Pediatric, Child, Children, Teen, Adolescent

• Protocol Short Name and Number: MM CAR-T to Upgrade Response, 1902
• Protocol Long Name: Phase II Multicenter Trial of anti-B Cell Maturation Antigen Chimeric Antigen Receptor T Cell Therapy for Multiple Myeloma Patients with Sub-Optimal Response After Autologous Hematopoietic Cell Transplantation and Maintenance Lenalidomide
• Protocol (PDF)
• ICFs (PDF)
• FAQs (PDF)
• Key Personnel
  • BMT CTN # 1902 Co-Chair: Sergio Giralt, MD
  • BMT CTN # 1902 Co-Chair: Alfred Garfall, MD
  • BMT CTN # 1902 Protocol Sponsor: Marcelo Pasquini, MD
  • BMT CTN # 1902 Protocol Coordinator: Ade Bakare; bmtctn1902@emmes.com
• Keywords: Multiple Myeloma, MM, Autologous Hematopoietic Cell Transplant, Auto Transplant, Autologous Transplant, Auto, HCT, HSCT, Anti-B Cell Maturation Antigen, BCMA, CAR-T, CAR T, CART, bb2121

• Protocol Short Name and Number: T-Guard for SR aGVHD, 1802
• Protocol Long Name: An Open-Label, Single-Arm, Multicenter Study of Combination anti- CD3/CD7 Immunotoxin (T-Guard) for Steroid-Refractory Acute Graft- versus-Host Disease
• Protocol Synopsis (PDF)
• Key Personnel
  • BMT CTN # 1802 Co-Chair: John Levine, MD
  • BMT CTN # 1802 Co-Chair: Gabrielle Meyers, MD
  • BMT CTN # 1802 Protocol Officer: Mehdi Hamadani, MD
• Keywords: T-Guard, TGuard, Graft versus Host Disease, Graft vs. Host Disease, GVHD, Xenikos, Anti-CD3/CD7 Immunotoxin, GVHD Treatment, Pediatric, Child, Children, Teen, Adolescent

• Protocol Short Name and Number: SWOG S1803 MM Maintenance, 1706
• Protocol Long Name: Phase III Study of Daratumumab (NSC- 791647) + Lenalidomide (LD) or Lenalidomide (L) as Post-Autologous Stem Cell Transplant Maintenance Therapy in Patients with Multiple Myeloma (MM) Using Minimal Residual Disease to Direct Therapy Duration (DRAMMATIC Study)
• Key Personnel
  • BMT CTN # 1706 Chair: Parameswaran Hari, MD, MRCP
  • BMT CTN # 1706 Protocol Coordinator: Cynthia Smith; csmith@swog.org
• Keywords: Multiple Myeloma, MM, Daratumumab, Lenalidomide, LD, DRAMMATIC, Maintenance

Note: For the SWOG S1803 / BMT CTN 1706 study, the BMT CTN is endorsing the study and providing accrual credit. Centers participate via their NCTN group. BMT CTN Centers will receive both NCTN and BMT CTN accrual credits. The protocol may be accessed through the CTSU website: https://www.ctsu.org/. For questions about the study and how to participate, contact the SWOG protocol coordinator, Cynthia Smith, at csmith@swog.org or the CTSU Help Desk at ctsucontact@westat.com or 1 888 823-5923.

• Protocol Short Name and Number: AAT GVHD Treatment, 1705
• Protocol Long Name: A Randomized, Double-Blind, Placebo-Controlled Multicenter Phase III Trial of Alpha 1 – Antitrypsin (AAT) Combined with Corticosteroids vs Corticosteroids Alone for the Treatment of High Risk Acute Graft-versus-Host Disease (GVHD) Following Allogeneic Hematopoietic Stem Cell Transplant
• Protocol Synopsis (PDF)
• ICFs (PDF)
• FAQs (PDF)
• Key Personnel
  • BMT CTN # Co-Chair: Amin Alousi
  • BMT CTN # Co-Chair: John Magenau
  • Protocol Officer: Mehdi Hamadani, MD
  • Protocol Coordinator: Erika Hoehn; bmtctn1705@emmes.com
• Keywords: Alpha-1 Antitrypsin, AAT, Graft versus Host Disease, GVHD, Graft vs. Host Disease, GVHD Treatment, Quality of Life, QOL, Patient Reported Outcomes, PROs, Pediatric, Child, Children, Teen, Adolescent

• Protocol Short Name and Number: CHARM, 1704
• Protocol Long Name: Composite Health Assessment Model for Older Adults: Applying Pre-transplant Comorbidity, Geriatric Assessment, and Biomarkers to Predict Non-Relapse Mortality after Allogeneic Transplantation
• Protocol (PDF)
• ICFs (PDF)
• FAQs (PDF)
• Key Personnel
  • BMT CTN # 1704 Co-Chair: Andrew Artz, MD
  • BMT CTN # 1704 Co-Chair: Mohamed Sorror, MD, MSc
  • BMT CTN # 1704 Protocol Officer: Wael Saber, MD, MS
  • BMT CTN # 1704 Protocol Coordinator: Bailey Protz; bmtctn1704@nmdp.org
• Keywords: CHARM, Allogeneic Transplant, Allo Transplant, Allo, HCT, Biomarkers, Geriatric, Quality of Life, QOL, Patient Reported Outcomes, PROs

• Protocol Short Name and Number: PROGRESS III – PTCY vs. TAC/MTX / Mi-Immune, 1703/1801
• Protocol Long Name:
  • BMT CTN 1703: A Randomized, Multicenter, Phase III Trial of Tacrolimus/Methotrexate versus Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil in Non-Myeloablative/Reduced Intensity Conditioning Allogeneic Peripheral Blood Stem Cell Transplantation
  • BMT CTN 1801: Companion Study: Microbiome and Immune Reconstitution in Cellular Therapies and Hematopoietic Stem Cell Transplantation (Mi-Immune)
• Protocol (PDF)
• ICFs (PDF)
• FAQs (PDF)
• Key Personnel (BMT CTN 1703)
  • BMT CTN # 1703 Co-Chair: Shernan Holtan, MD
  • BMT CTN # 1703 Co-Chair: Javier Bolanos-Meade, MD
  • BMT CTN # 1703 Protocol Officer: Mehdi Hamadani, MD
  • BMT CTN # 1703 Protocol Coordinator: Kristy Applegate, MBA; bmtctn1703@emmes.com
• Key Personnel (BMT CTN 1801)
  • BMT CTN # 1801 Co-Chair: Miguel-Angel Perales, MD
  • BMT CTN # 1801 Co-Chair: Leslie Kean, MD, PhD
  • BMT CTN # 1801 Co-Chair: Ami Bhatt, MD, PhD
  • BMT CTN # 1801 Protocol Officer: Wael Saber, MD, MS
  • BMT CTN # 1801 Protocol Coordinator: Kristy Applegate, MBA;  bmtctn1703@emmes.com
• Keywords: PROGRESS, Mi-Immune, Graft versus Host Disease, GVHD Prophylaxis, GVHD, Post-Transplant Cyclophosphamide, PTCY, Microbiome, Allogeneic Transplant, Allo Transplant, Allo, Unrelated donor, Unrelated, Hematopoietic Stem Cell Transplant, HSCT, HCT, Quality of Life, QOL, Patient Reported Outcomes, PROs, Tacrolimus, TAC, Tacro, Methotrexate, MTX, Mycophenolate Mofetil, MMF, Acute Leukemia, Chronic Myelogenous Leukemia, CML, Myelodysplastic Syndrome, MDS, Chronic Myelomonocytic Leukemia, CMML, Chronic Lymphocytic Leukemia, CLL, Lymphoma, Leukemia

• Protocol Short Name and Number: CTRL-ALT-D, 1702
• Protocol Long Name: Clinical Transplant-Related Long-term Outcomes of Alternative Donor Allogeneic Transplantation
• Protocol (PDF)
• ICFs (PDF)
• FAQs (PDF)
• Key Personnel
  • BMT CTN # 1702 Co-Chair: Stephanie Lee, MD
  • BMT CTN # 1702 Co-Chair: Stefan Ciurea, MD
  • BMT CTN # 1702 Protocol Officer: Bronwen Shaw, MD, PhD
  • BMT CTN # 1702 Protocol Coordinator: Jenny Vogel; bmtctn1702@nmdp.org
• Keywords: Long-Term Outcomes, Alternative Donor, Allogeneic Transplant, Allo Transplant, Allo, Observational, Quality of Life, QOL, Patient Reported Outcomes, PROs, Leukemia, Acute Myelogenous Leukemia, AML, Acute Lymphoblastic Leukemia, ALL, Myelodysplastic Syndrome, MDS, NHL, HL, Lymphoma, Hodgkin, Aplastic Anemia, AA, Sickle Cell Disease, SCD, Sickle Cell, Unrelated, Unrelated Donor, CTRL-ALT-D, HSCT, HCT, Pediatric, Child, Children, Teen, Adolescent

• Protocol Short Name and Number: ECOG-ACRIN EA4151 MCL, 1601
• Protocol Long Name: A Randomized Phase III Trial of Consolidation with Autologous Hematopoietic Cell Transplantation Followed by Maintenance Rituximab vs. Maintenance Rituximab Alone for Patients with Mantle Cell Lymphoma In Minimal Residual Disease-Negative First Complete Remission
• Key Personnel
  • BMT CTN # 1601 Protocol Chair: Timothy Fenske, MD
  • BMT CTN # 1601 Chair: Matthew Lunning, MD
  • BMT CTN # 1601 Protocol Coordinator: Christiana Samuel, csamuel@ecog-acrin.org     
  • BMT CTN # 1601 Protocol Coordinator: Amy Foley, afoley@nmdp.org
• Keywords: Auto Transplant, Autologous Hematopoietic Cell Transplant, HCT, Autologous Transplant, Auto, Rituximab, Mantle Cell Lymphoma, MCL

Note: For the ECOG-ACRIN EA4151/BMT CTN 1601 study, the BMT CTN is endorsing the study and providing accrual credit. Centers participate via their NCTN group. BMT CTN Centers will receive both NCTN and BMT CTN accrual credits. The protocol may be accessed through the CTSU website: https://www.ctsu.org  For questions about the study and how to participate, contact the ECOG-ACRIN protocol coordinator, Haleigh Wetzel, at hwetzel@ecog-acrin.org or 857-504-2900, or the CTSU Help Desk at  ctsucontact@westat.com or 1 888 823-5923.

• Protocol Short Name and Number: Haplo Sickle Cell, 1507
• Protocol Long Name: Reduced Intensity Conditioning for Haploidentical Bone Marrow Transplantation in Patients with Symptomatic Sickle Cell Disease.
• Protocol (PDF)
• ICFs (PDF)
• FAQs (PDF)
• Key Personnel
  • BMT CTN # 1507 Co-Chair: Michael DeBaun, MD
  • BMT CTN # 1507 Co-Chair: Mark Walters, MD
  • BMT CTN # 1507 Co-Chair: Adetola Kassim, MD
  • BMT CTN # 1507 Co-Chair: Robert Brodsky, MD
  • BMT CTN # 1507 Protocol Officer: Mary Eapen, MD, MS
  • BMT CTN # 1507 Protocol Coordinator: Megan Scott, bmtctn1507@emmes.com 
• Keywords: Sickle Cell Disease, SCD, Sickle Cell, SC, Haplo, Haploidentical Transplant, Reduced Intensity, Allo Transplant, Allogeneic Transplant, Quality of Life, QOL, Patient Reported Outcomes, PROs, Pediatric, Child, Children, Teen, Adolescent

• Protocol Short Name and Number: AML FLT3 Maintenance Therapy, 1506
• Protocol Long Name: A multi-center, randomized, double-blind, placebo-controlled Phase III trial of the FLT3 inhibitor gilteritinib administered as maintenance therapy following allogeneic transplant for patients with FLT3/ITD AML
• Protocol (PDF)
• Key Personnel
  • BMT CTN # 1506 Co-Chair: Mark Levis, MD
  • BMT CTN # 1506 Co-Chair: Yi-Bin Chen, MD
  • BMT CTN # 1506 Protocol Officer: Mehdi Hamadani, MD
  • BMT CTN # 1506 Protocol Coordinator: 1506DCC@emmes.com
• Keywords: AML, Acute Myelogenous Leukemia, FLT3, Maintenance Therapy, Maintenance, FLT3 inhibitor gilteritinib

A Randomized Recruitment Intervention Trial.

This study is posted on clinicaltrials.gov as NCT01911208

Key Personnel

•    Protocol Chair: Barbara Tilley Barbara.C.Tilley@uth.tmc.edu
•    Protocol Coordinator: Amy Foley afoley@nmdp.org

Keywords: RECRUIT, Diversity, Recruitment, Racial Diversity, Ethnic Diversity, Minority, Minority Recruitment

• Protocol Short Name and Number: STRIDE2, 1503
• Protocol Long Name: A Study to Compare Bone Marrow Transplantation to Standard Care in Adolescents and Young Adults with Severe Sickle Cell Disease
• Protocol (PDF)
• ICFs (PDF)
• FAQs (PDF)
• Key Personnel
  • BMT CTN # 1503 Co-Chair: Lakshmanan Krishnamurti, MD
  • BMT CTN # 1503 Co-Chair: Mark Walters, MD
  • BMT CTN # 1503 Protocol Officer: Mary Eapen, MD, MS
  • BMT CTN # 1503 Protocol Coordinator: bmtctn1503@emmes.com
• Keywords: Sickle Cell Disease, SCD, Sickle Cell, SC, Adolescents, Unrelated Donor, Allogeneic Transplant, Allo Transplant, Quality of Life, QOL, Pediatric, Child, Children, Teen, Adolescent

• Protocol Short Name and Number: CHAMP, 1502
• Protocol Long Name: Optimizing Haploidentical Aplastic Anemia Transplantation (CHAMP)
• Protocol (PDF)
• ICFs (PDF)
• FAQs (PDF)
• Key Personnel
  • BMT CTN # 1502 Co-Chair: Michael (Mike) Pulsipher, MD
  • BMT CTN # 1502 Co-Chair: Amy DeZern, MD, MS-HS
  • BMT CTN # 1502 Protocol Officer: Mary Eapen, MD
  • BMT CTN # 1502 Protocol Coordinator: Kristy Applegate; bmtctn1502@emmes.com
• Keywords: Haplo, Haploidentical Transplant, Allo Transplant, Allogeneic Transplant, Allo, Aplastic Anemia, AA, Severe Aplastic Anemia, SAA, Quality of Life, QOL, Pediatric, Child, Children, Teen, Adolescent

• Protocol Short Name and Number: SR aGVHD, 1501
• Protocol Long Name: A Randomized, Phase II, Multicenter, Open Label, Study Evaluating Sirolimus and Prednisone in Patients with Refined Minnesota Standard Risk, Ann Arbor 1/2 Confirmed Acute Graft-Versus-Host Disease
• Protocol (PDF)
• Protocol Synopsis (PDF)
• Informed Consent and Assent Local IRBs (PDF)
• Informed Consent and Assent NMDP IRB (PDF)
• Frequently Asked Questions (PDF)
• Key Personnel
  • BMT CTN # 1501 Protocol Co-Chair: Joseph Pidala, MD, PhD
  • BMT CTN # 1501 Protocol Co-Chair: Margaret MacMillan, MD
  • BMT CTN # 1501 Protocol Officer: Mehdi Hamadani, MD      
  • BMT CTN # 1501 Protocol Coordinator: bmtctn@emmes.com
• Keywords: Graft versus Host Disease, GVHD, Graft vs. Host Disease, GVHD Treatment, Sirolimus, Quality of Life, QOL, Ann Arbor, Pediatric, Child, Children, Teen, Adolescent

This study reached its accrual goal on February 16, 2018 and is now closed to new patient enrollment.

• Protocol Short Name and Number: Myeloma Vaccine, 1401
• Protocol Long Name: A Phase II Multicenter Trial of Single Autologous Hematopoietic Cell Transplant Followed by Lenalidomide Maintenance for Multiple Myeloma with or without Vaccination with Dendritic Cell/Myeloma Fusions
• Protocol (PDF)
• ICFs (PDF)
• FAQs (PDF)
• Key Personnel
  • BMT CTN # 1401 Co-Chair: David Avigan MD
  • BMT CTN # 1401 Co-Chair: Nina Shah, MD
  • BMT CTN # 1401 Co-Chair: David Chung, MD
  • BMT CTN # 1401 Protocol Officer: Marcelo Pasquini, MD
  • BMT CTN # 1401 Protocol Coordinator: Nicole Ritzau, RN; bmtctn1401@emmes.com
• Keywords: Vaccine, Vaccination, Lenalidomide, Maintenance, Multiple Myeloma, MM, Dendritic Cell, Auto Transplant, Autologous Transplant, Auto

• Protocol Short Name and Number:  DFCI 10-106/ BMT CTN 1304 DETERMINATION
• Protocol Long Name: A Randomized Phase III Study Comparing Conventional Dose Treatment Using a Combination of Lenalidomide, Bortezomib and Dexamethasone (RVD) to High-Dose Treatment with Peripheral Stem Cell Transplant in the Initial Management of Myeloma in Patients up to 65 Years of Age.
• Protocol
• Key Personnel
  • BMT CTN # 1304  Protocol Chair: Paul Richardson
  • BMT CTN # 1304  Protocol Coordinator: Amy Foley afoley@nmdp.org          
• Keywords: Lenalidomide, Bortezomib, Dexamethasone, RVD, Multiple Myeloma, MM, Quality of Life, QOL, Auto Transplant, Autologous Transplant, Auto, Consolidation, Maintenance, Pediatric, Child, Children, Teen, Adolescent

• Protocol Short Name and Number: Allogeneic Hematopoietic Stem Cell Transplantation With Ixazomib for High Risk Multiple Myeloma, 1302
• Protocol Long Name: Multicenter Phase II, Double-blind Placebo Controlled Trial of Maintenance Ixazomib after Allogeneic Hematopoietic Stem Cell Transplantation for High Risk Multiple Myeloma
• Protocol (PDF)
• ICFs (PDF)
• FAQs (PDF)
• Key Personnel
  • BMT CTN # 1302 Co-Chair: Qaiser Bashir, MD
  • BMT CTN # 1302 Co-Chair: Taiga Nishihori, MD
  • BMT CTN # 1302 Co-Chair: Parameswaran Hari, MD
  • BMT CTN # 1302 Protocol Officer: Marcelo Pasquini, MD, MS
  • BMT CTN # 1302 Protocol Coordinator: Kristy Applegate; bmtctn1302@emmes.com
• Keywords: Multiple Myeloma, MM, Ixazomib, Allogeneic Transplant, Allo Transplant, Allo, Quality of Life, QOL, Maintenance, Unrelated Donor, Unrelated

• Protocol Short Name and Number: CNI-free GVHD (PROGRES II), 1301
• Protocol Long Name: A Randomized, Multi-Center, Phase III Trial of Calcineurin Inhibitor-Free Interventions for Prevention of Graft-versus-Host Disease
• Protocol (PDF)
• ICFs (PDF)
• FAQs (PDF)
• Key Personnel
  • BMT CTN # 1301 Co-Chair: Miguel-Angel Perales, MD
  • BMT CTN # 1301 Co-Chair: Leo Luznik, MD
  • BMT CTN # 1301 Protocol Officer: Marcelo Pasquini, MD, MS
  • BMT CTN # 1301 Protocol Coordinator: Kristy Applegate, MBA; bmtctn1301@emmes.com
• Keywords: Allo Transplant, Allogeneic Transplant, Allo, Unrelated, Unrelated Donor, HSCT, HCT, Graft versus Host Disease, GVHD, Graft vs. Host Disease, Prophylaxis, Quality of Life, QOL, Calcineurin Inhibitor-Free, CNI, Tacrolimus, TAC, Methotrexate, MTX, Acute Leukemia, Myelodysplastic Syndrome, MDS, Chronic Myelomonocytic Leukemia, CMML, Leukemia, PROGRESS, CliniMACS, Pediatric, Child, Children, Teen, Adolescent

• Protocol Short Name and Number: ETRIC, 1205
• Protocol Long Name: Easy-to-Read Informed Consent (ETRIC) for Hematopoietic Cell Transplantation Clinical Trials
• Protocol (PDF)
• Protocol Synopsis (PDF)
• ETRIC 1101 v5.0 Informed Consent (PDF)
• ETRIC 1301 v3.0 Informed Consent (PDF)
• ETRIC 1203 v3.0 Informed Consent (PDF)
• Frequently Asked Questions (PDF)
• Key Personnel
  • BMT CTN # 1205 Protocol Co-Chair: Navneet S Majhail, MD
  • BMT CTN # 1205 Protocol Co-Chair: Ryan Spellecy, PhD  
  • BMT CTN # 1205 Protocol Officer: Navneet S Majhail, MD
  • BMT CTN # 1205 Protocol Coordinator: bmtctn@emmes.com
• Keywords: ETRIC, Easy-to-Read, Easy to Read, Quality of Informed Consent

• Protocol Short Name and Number: RICHI, 1204
• Protocol Long Name: Reduced-Intensity Conditioning for Children and Adults with Hemophagocytic Syndromes or Selected Primary Immune Deficiencies.
• Protocol (PDF)
• Protocol Synopsis (PDF)
• Informed Consent and Assent
• Frequently Asked Questions
• Key Personnel
  • BMT CTN # 1204 Protocol Co-Chair: Carl Allen, MD
  • BMT CTN # 1204  Protocol Co-Chair: M. Pulsipher, MD
  • BMT CTN # 1204 Protocol Officer: Mary Eapen, MD
  • BMT CTN # 1204 Medical Monitor: Liza Thiel, MD
• Keywords: RICHI, Hemophagocytic, Primary Immune Deficiencies, Epstein-Barr Virus, EBV, Epstein Barr, CAEBV, Chronic Granulomatous Disease, CGD, X-linked Hyper IgM Syndrome, HIGM1, IPEX, Leukocyte Adhesion Syndrome, LAD-I, LAD, Hemophagocytic Lymphohistiocytosis, HLH, Reduced Intensity Conditioning, Allogeneic Transplant, Allo Transplant, Allo, Unrelated, Unrelated Donor, Pediatric, Child, Children, Teen, Adolescent

Accrual for the BMT CTN 1204 trial closed on December 4, 2015.

• Protocol Short Name and Number: GVHD Prophylaxis (PROGRESS I), 1203
• Protocol Long Name: A Multi-center Phase II Trial Randomizing Novel Approaches for Graft-versus-Host Disease Prevention Compared to Contemporary Controls.
• Protocol (PDF)
• Informed Consent 
• Frequently Asked Questions
• Key Personnel
  • BMT CTN # 1203 Protocol Co-Chair: Javier Bolanos-Meade, MD
  • BMT CTN # 1203 Protocol Co-Chair: John Koreth, MD
  • BMT CTN # 1203 Protocol Co-Chair: Ran Reshef , MD
  • BMT CTN # 1203 Protocol Officer: Marcelo Pasquini, MD
  • BMT CTN # 1203 Protocol Coordinator: bmtctn@emmes.com
• Keywords: PROGRESS, Prophylaxis, Graft versus Host Disease, GVHD, Graft vs. Host Disease, Unrelated, Unrelated Donor, Allogeneic Transplant, Allo Transplant, Allo, Acute leukemia, Leukemia, Chronic Myelogenous Leukemia, CML, Chronic Lymphocytic Leukemia, CLL, Myelodysplastic Syndrome, MDS, Lymphoma, Quality of Life, QOL

BMT CTN # 1203 Medical Monitor: Shannon Smiley, MD

• Protocol Short Name and Number: Biomarkers, 1202
• Protocol Long Name: Prospective Multi-Center Cohort for the Evaluation of Biomarkers Predicting Risk of Complications and Mortality Following Allogeneic HCT.
• Protocol (PDF), version 3.0 dated March 17, 2015
• Protocol Synopsis (PDF), version 3.0 dated March 17, 2015
• Summary of Changes from version 2.0 to 3.0 (PDF)
• Informed Consent and Assent (PDF), version 3.0 dated March 17, 2015
• FAQs (PDF)
• Key Personnel
  • BMT CTN# 1202 Co-Chair: John Levine, MD 
  • BMT CTN# 1202 Protocol Co-Chair: John Hansen, MD 
  • BMT CTN# 1202 Protocol Officer and Medical Monitor: Wael Saber, MD
  • BMT CTN# 1202 Protocol Coordinator: bmtctn@emmes.com           
• Keywords: Biomarkers, Correlative Studies, Biological Samples, Biospecimen, Pediatric, Child, Children, Teen, Adolescent

The BMT CTN is committed to including widespread transplant community participation in these trials. For information on how to apply to participate on this study, please contact the Protocol Coordinator at bmtctn@emmes.com for details.

• Protocol Short Name and Number:  Alliance A051301/BMT CTN1201 DLBCL
• Protocol Long Name: A Randomized Double-Blind Phase III Study of Ibrutinib During and Following Autologous Stem Cell Transplantation Versus Placebo in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma of the Activated B-cell Subtype

• For access to Protocol documents please visit the CTSU site: https://www.ctsu.org
• Key Personnel
  • BMT CTN # 1201 Protocol Chair: Charalambos Babis Andreadis, MD, MSCz (Alliance)
  • BMT CTN # 1201 Protocol Chair: Timothy Fenske, MD (BMT CTN)
  • BMT CTN # 1201  Protocol Coordinator: Destin Carlisle: dcarlisle@bsd.uchicago.edu
• Keywords: Ibrutinib, Autologous Transplant, Auto Transplant, Auto, Large B-Cell Lymphoma, Lymphoma, DLBCL, Alliance, A051301

For the Alliance A051301/BMT CTN 1201 study, centers participate via their NCTN group. The protocol may be accessed through the CTSU website: https://www.ctsu.org. For questions, contact the CTSU Help Desk: ctsucontact@westat.com or 1-888-823-5923.
To participate, follow the NCTN activation process. Contact Alliance protocol coordinator, Destin Carlisle, at dcarlisle@uchicago.edu for more information.

• Protocol Short Name and Number: RIC vs Hypometh for MDS, 1102
• Protocol Long Name: A Multi-Center Biologic Assignment Trial Comparing Reduced Intensity Allogeneic Hematopoietic Cell Transplant to Hypomethylating Therapy or Best Supportive Care in Patients Aged 50-75 with Intermediate-2 and High Risk Myelodysplastic Syndrome
• Protocol (PDF)
• ICFs (PDF)
• FAQs (PDF)
• Key Personnel
  • BMT CTN # 1102 Co-Chair: Corey Cutler, MD, MPH, FRCP(C)
  • BMT CTN # 1102 Co-Chair: Ryotaro (Ryo) Nakamura, MD
  • BMT CTN # 1102 Protocol Officer: Wael Saber, MD, MS
  • BMT CTN # 1102 Protocol Coordinator: Kristy Applegate; bmtctn1102@emmes.com
• Keywords: Myelodysplastic Syndrome, MDS, Allogeneic Transplant, Allo Transplant, Allo, Reduced Intensity Conditioning, RIC, Biologic Assignment, Quality of Life, QOL, Unrelated, Unrelated Donor

• Protocol Short Name and Number: Double cord vs. Haplo, 1101
• Protocol Long Name: A Multi-Center, Phase III, Randomized Trial of Reduced Intensity(RIC) Conditioning and Transplantation of Double Unrelated Umbilical Cord Blood (dUCB) versus HLA-Haploidentical Related Bone Marrow (Haplo) for Patients with Hematologic Malignancies
• Protocol (PDF)
• ICFs (PDF)
• FAQs (PDF)
• Key Personnel
  • BMT CTN # 1101 Co-Chair: Ephraim Fuchs, MD
  • BMT CTN # 1101 Co-Chair: Paul O’Donnell, MD, PhD
  • BMT CTN # 1101 Co-Chair: Claudio Brunstein, MD
  • BMT CTN # 1101 Protocol Officer: Mary Eapen, MD, MS
  • BMT CTN # 1101 Protocol Coordinator: Nicole Ritzau, RN; bmtctn1101@emmes.com
• Keywords: Cord blood, Reduced Intensity Conditioning, RIC, Haploidentical transplant, Haplo Transplant, Haplo, Allogeneic Transplant, Allo Transplant, Allo, Leukemia, Lymphoma, Natural Killer Cell Malignancies, Quality of Life, QOL

• Protocol Short Name and Number: Allo Transplant in HIV, 0903
• Protocol Long Name: Allogeneic Hematopoietic Cell Transplant for Hematological Cancers and Myelodyplastic Syndromes in HIV-infected Patients
• Protocol (PDF)
• Informed Consent and Assent
• Frequently Asked Questions
• Key Personnel
  • BMT CTN # 0903 Protocol Chair: Joseph Alvarnas, MD
  • BMT CTN # 0903 Protocol Co-Chair: Richard Ambinder, MD  
  • BMT CTN # 0903 Protocol Officer: Willis Navarro
  • BMT CTN # 0903 Medical Monitor: Tammy Kindwall-Keller, MD
  • BMT CTN # 0903 Protocol Coordinator:  bmtctn@emmes.com
• Keywords: HIV, Allogeneic Transplant, Allo Transplant, Allo, Leukemia, Acute Myelogenous Leukemia, AML, Acute Lymphocytic Leukemia, ALL, Myelodysplastic Syndrome, MDS, Lymphoma, HL, NHL, Unrelated, Unrelated Donor, Pediatric, Child, Children, Teen, Adolescent

The BMT CTN 0903 study closed to new patient accrual on December 3, 2015.

• Protocol Short Name and Number: Peri-Transplant Stress Mgmt, 0902
• Protocol Long Name: A Phase III Randomized, Multicenter Trial Testing Whether Exercise or Stress Management Improves Functional Status and Symptoms of Autologous and Allogeneic Recipients.
• Protocol (PDF)
• Informed Consent
• Frequently Asked Questions 
• Key Personnel
  • BMT CTN # 0902 Protocol Chair: Stephanie Lee, MD
  • BMT CTN # 0902 Protocol Co-Chair: Paul Jacobsen, PhD
  • BMT CTN # 0902 Medical Monitor: Gabrielle Meyers, MD
  • BMT CTN # 0902 Protocol Coordinator:  bmtctn@emmes.com
• Keywords: Exercise, Stress Management, Quality of Life, QOL

This study reached targeted accrual on June 1, 2012 and is now closed to new patient enrollment.

• Protocol Short Name and Number: Full vs RIC in MDS/AML, 0901
• Protocol Long Name: A Randomized, Multi-Center, Phase III Study of Allogeneic Stem Cell Transplantation Comparing Regimen Intensity in Patients with Myelodysplastic Syndrome or Acute Myeloid Leukemia
• Protocol (PDF)
• Protocol Synopsis (PDF)
• Informed Consent (PDF)
• Key Personnel
  • BMT CTN # 0901 Protocol Co-Chair: Mitchell Horwitz, MD
  • BMT CTN # 0901 Protocol Co-Chair: Bart Scott, MD  
  • BMT CTN # 0901 Protocol Officer: Marcello Pasquini, MD
  • BMT CTN # 0901 Medical Monitor: Bipin Savani, MD
  • BMT CTN # 0901 Protocol Coordinator:  bmtctn@emmes.com
• Keywords: Allogeneic Transplant, Allo Transplant, Allo, Reduced Intensity Conditioning, RIC, Myeloablative Conditioning, Acute Myelogenous Leukemia, AML, Myelodysplastic Syndrome, MDS, Unrelated, Unrelated Donor. Quality of Life, QOL

This study was closed to new patient accrual on April 18, 2014.

• Protocol Short Name and Number:  SWOG S#0805 / BMT CTN0805 ALL
• Protocol Long Name: Phase II Study Of Combination Of Hyper-CVAD And Dasatinib With Or Without Allogeneic Stem Cell Transplant In Patients With Philadelphia (Ph) Chromosome Positive and/or Bcr-Abl Positive Acute Lymphoblastic Leukemia (ALL) (A BMT Study)
• Protocol (PDF)
• Key Personnel
  • BMT CTN # 0805 Protocol Chair: Farhad Ravandi, MD
  • BMT CTN # 0805 Protocol Chair: David Porter, MD
• Keywords: SWOG, S0805, Hyper-CVAD, Sadatinib, Acute Lymphocytic Leukemia, ALL, Leukemia, Allo Transplant, Allogeneic Transplant, Allo, Unrelated, Unrelated Donor

  This study was closed to new patient accrual on October 1, 2013.

• Protocol Short Name and Number:  CALGB 100701/ BMT CTN 0804 CLL
• Protocol Long Name: Phase II Study of Reduced- Intensity Allogeneic Stem Cell Transplant For High Risk Chronic Lymphocytic Leukemia (CLL)
• For access to Protocol documents please visit the CTSU site: https://www.ctsu.org
• Key Personnel
  •  BMT CTN # 0804 Protocol Chair: Richard T. Maziarz, MD
  •  BMT CTN # 0804 Protocol Officer: Mary Horowitz, MD
  •  Alliance Regulatory Group: regulatory@alliancenctn.org
• Keywords: CALGB, 100701, Reduced Intensity, RIC, Chronic Lymphocytic Leukemia, CLL, Leukemia, Allogeneic Transplant, Allo Transplant, Allo, Unrelated, Unrelated Donor

This study has reached its final accrual goal; the study closed to new patient accrual on January 27, 2014.

• Protocol Short Name and Number: Auto Transplant in HIV, 0803
• Protocol Long Name: High Dose Chemotherapy with Autologous Stem Cell Rescue for Aggressive B Cell Lymphoma and Hodgkin Lymphoma in HIV-infected Patients
• Protocol (PDF)
• Informed Consent and Assent
• Frequently Asked Questions 
• Key Personnel
  • BMT CTN # 0803 Protocol Chair: Joseph Alvarnas, MD
  • BMT CTN # 0803 Protocol Co-Chair: Richard Ambinder, MD
  • BMT CTN # 0803 Protocol Officer: Willis Navarro
  • BMT CTN # 0803 Protocol Coordinator: bmtctn@emmes.com
  • BMT CTN # 0803 Medical Monitor: Bipin Savani
• Keywords: Autologous Transplant, Auto Transplant, Auto, Lymphoma, HIV, Pediatric, Child, Children, Teen, Adolescent

This study reached its target patient accrual on May 15, 2013 and is closed to new enrollment.

• Protocol Short Name and Number: aGVHD Phase III, 0802
• Protocol Long Name: A Multi-Center, Randomized, Double Blind, Phase III Trial Evaluating Corticosteroids with Mycophenolate Mofetil vs. Corticosteroids with Placebo as Initial Systemic Treatment of Acute GVHD
• Protocol (PDF)
• Informed Consent and Assent 
• Frequently Asked Questions 
• Key Personnel
  • BMT CTN # 0802 Protocol Chair: Javier Bolanos-Meade, MD  
  • BMT CTN # 0802 Protocol Co-Chair: Vincent T. Ho, MD  
  • BMT CTN # 0802 Protocol Officer: Mary Horowitz, MD  
  • BMT CTN # 0802 Protocol Coordinator: bmtctn@emmes.com
  • BMT CTN # 0802 Medical Monitor: Dianna Howard, MD
• Keywords: Graft versus Host Disease, GVHD, Graft vs. Host Disease, Treatment, Mycophenolate Mofetil, MMF, Patient Reported Outcomes, PROs, Quality of Life, QOL, Pediatric, Child, Children, Teen, Adolescent

The BMT CTN 0802 study closed to new patient accrual on November 14, 2011.

• Protocol Short Name and Number: cGVHD Treatment, 0801
• Protocol Long Name: A Phase II/III Randomized, Multicenter Trial Comparing Sirolimus plus Prednisone, and Sirolimus/Calcineurin Inhibitor plus Prednisone for the Treatment of Chronic Graft-versus-Host Disease
• Protocol (PDF)
• Informed Consent and Assent 
• Frequently Asked Questions 
• Key Personnel
  • BMT CTN # 0801 Protocol co-Chair: Paul Carpenter, MD, BS  
  • BMT CTN # 0801 Protocol co-Chair: Mukta Arora, MD
  • BMT CTN # 0801 Protocol Officer: Marcelo Pasquini, MD
  • BMT CTN # 0801 Protocol Coordinator: bmtctn@emmes.com
  • BMT CTN # 0801 Medical Monitor: Bipin Savani
• Keywords: Treatment, Graft versus Host Disease, Graft vs. Host Disease, GVHD, Sirolimus, Quality of Life, QOL, Pediatric, Child, Children, Teen, Adolescent

The BMT CTN 0801 study closed to new patient accrual on December 9, 2013.  

• Protocol Short Name and Number: 0702 LTFU, 07LT
• Protocol Long Name: Continued, Long-Term Follow-Up and Lenalidomide Maintenance Therapy for Patients Who Have Enrolled on BMT CTN 0702
• Protocol (PDF)
• Protocol Synopsis (PDF) 
• Informed Consent 
• Frequently Asked Questions 
• Key Personnel
  • BMT CTN # 07LT Protocol Co-Chair: Amrita Krishnan, MD  
  • BMT CTN # 07LT Protocol Co-Chair: George Somlo, MD  
  • BMT CTN # 07LT Protocol Co-Chair: Ed Stadtmauer, MD
  • BMT CTN # 07LT Protocol Officer: Marcelo Pasquini, MD  
  • BMT CTN # 07LT Medical Monitor: Shannon Smiley, MD
  • BMT CTN # 07LT Protocol Coordinator:  bmtctn@emmes.com
• Keywords: Lenalidomide, Multiple Myeloma, MM, Quality of Life, QOL, Revlimid, Maintenance

This study is a sub-study of BMT CTN 0702. All site with at least one patient enrolled on BMT CTN 0702 are eligible to open this study.

• Protocol Short Name and Number:  CALGB 100104 / BMT CTN0704 Myeloma
• Protocol Long Name: A Phase III Randomized, Double-Blind Study of Maintenance Therapy With Cc-5013 (Nsc # 703813, Ind # 70116) Or Placebo Following Autologous Stem Cell Transplantation For Multiple Myeloma
• For access to Protocol documents please visit the CTSU site: https://www.ctsu.org

• Key Personnel
  • BMT CTN # 0704 Protocol Chair: Phil McCarthy, MD
  • BMT CTN # 0704 Protocol Chair: Kenneth Anderson, MD
  • BMT CTN # 0704 Protocol Chair: Sergio Giralt, MD
  • BMT CTN # 0704 Protocol Officer: Marcelo Pasquini, MD
  • ECOG Protocol Chair: Philip Greipp, MD
  • Alliance Regulatory Group: regulatory@alliancenctn.org
• Keywords: CALGB, 100104, Multiple Myeloma, MM, CC-5013, Maintenance

  This study was closed to new patient accrual on July 2, 2009.

• Protocol Short Name and Number:  SWOG #S0410 /BMT CTN0703 Hodgkin’s Lymphoma
• Protocol Long Name: Tandem Autologous Stem Cell Transplantation for Patients with Primary Progressive or Recurrent Hodgkin’s Disease (A BMT Study), Phase II
• For access to Protocol documents please visit the CTSU site: https://www.ctsu.org
• Key Personnel
  • SWOG Protocol Chair: Patrick Stiff, MD
  • BMT CTN # 0703 Protocol Chair: Ginna Laport, MD
  • SWOG Protocol Officer: Eileen Smith, MD
  • BMT CTN # 0703 Protocol Officer:  MarcieRiches, MD
• Keywords: SWOG, S0410, Hodgkin’s Lymphoma, HL, Auto, Autologous Transplant, Auto Transplant, HCT, HSCT, Tandem, Teen, Adolescent, Child, Children

This study reached target accrual and closed to patient accrual on July 19, 2009.

• Protocol Short Name and Number: STaMINA (multiple myeloma), 0702
• Protocol Long Name: A Trial of Single Autologous Transplant with or without Consolidation Therapy versus Tandem Autologous Transplant with Lenalidomide Maintenance for Patients with Multiple Myeloma
• Protocol (PDF)
• Protocol Synopsis (PDF)
• Informed Consent (PDF)
• Frequently Asked Questions 
• Key Personnel
  • BMT CTN # 0702 Protocol Co-Chair: Amrita Krishnan, MD
  • BMT CTN # 0702 Protocol Co-Chair: George Somlo, MD
  • BMT CTN # 0702 Protocol Co-Chair: Ed Stadtmauer, MD
  • BMT CTN # 0702 Protocol Officer: Marcelo Pasquini, MD  
  • BMT CTN # 0702 Protocol Coordinator: bmtctn@emmes.com
  • BMT CTN # 0702 Medical Monitor: Shannon Smiley, MD
• Keywords: STAMINA, Tandem, Auto, Autologous, Autologous Transplant, Multiple Myeloma, MM, Lenalidomide, Quality of Life QOL

This study reached its target accrual on November 15, 2013 and is closed to new patient enrollment.

• Protocol Short Name and Number: Follicular NHL, 0701
• Protocol Long Name: Phase II Trial of Non-Myeloablative Allogeneic Hematopoietic Cell Transplantation for Patients with Relapsed Follicular Non-Hodgkin’s Lymphoma Beyond First Complete Response
• Protocol (PDF)
• Informed Consent 
• Frequently Asked Questions
• Key Personnel
  • BMT CTN # 0701 Protocol Chair: Ginna Laport, MD  
  • BMT CTN # 0701 Protocol Officer: Marcie Tomblyn, MD
  • BMT CTN # 0701 Medical Monitor: Gabrielle Meyers, MD
  • BMT CTN # 0701 Protocol Coordinator:  bmtctn@emmes.com
• Keywords: Follicular, Non-Hodgkin’s Lymphoma, NHL, Lymphoma, Allogeneic Transplant, Allo Transplant, Allo, Quality of Life, QOL, Fludarabine, Cyclophosphamide, Rituximab, FCR, Non-Myeloablative, Unrelated, Unrelated Donor, Pediatric, Child, Children, Teen, Adolescent

This study reached its target patient accrual on October 22, 2012 and is closed to new enrollment.

• Protocol Short Name and Number: NST Cord Blood, 0604
• Protocol Long Name: A Multi-Center, Phase II Trial of Non-Myeloablative Conditioning (NST) and Transplantation of Umbilical Cord Blood (UCB) from Unrelated Donors in Patients with Hematologic Malignancies
• Protocol (PDF)
• Informed Consent and Assent Forms 
• Frequently Asked Questions 
• Key Personnel
  • BMT CTN # 0604 Protocol Chair: Claudio Brunstein, MD
  • BMT CTN # 0604 Protocol Officer: Mary Eapen, MD  
  • BMT CTN # 0604 Medical Monitor: Dianna Howard, MD
  • BMT CTN # 0604 Protocol Coordinator:  bmtctn@emmes.com
• Keywords: Non-myeloablative, UCB, Hematologic malignancies, Leukemia, Lymphoma, Allo Transplant, Allogeneic Transplant, Allo, Pediatric, Child, Children, Teen, Adolescent

This Study reached its target patient accrual on March 31, 2010 and is closed to new enrollment.

• Protocol Short Name and Number: NST Haploidentical, 0603
• Protocol Long Name: A Multi-Center, Phase II Trial of Nonmyeloablative Conditioning (NST) and Transplantation of Partially HLA-Mismatched Bone Marrow for Patients with Hematologic Malignancies
• Protocol (PDF)
• Informed Consent 
• Frequently Asked Questions
• Key Personnel 
  • BMT CTN # 0603 Protocol Co-chair: Ephraim Fuchs, MD  
  • BMT CTN # 0603 Protocol Co-chair: Paul O’Donnell, MD
  • BMT CTN # 0603 Protocol Officer: Mary Eapen, MD
  • BMT CTN # 0603 Protocol Coordinator: bmtctn@emmes.com
  • BMT CTN # 0603 Medical Monitor: Shannon Smiley, MD
• Keywords: Allo Transplant, Allogeneic Transplant, Allo, Haplo, Haploidentical, Non-Myeloablative, Hematologic malignancies, Leukemia, Lymphoma, Pediatric, Child, Children, Teen, Adolescent

This Study reached its target patient accrual on May 17, 2010 and is closed to new enrollment.

• Protocol Short Name and Number: Sickle Cell, 0601
• Protocol Long Name: Unrelated Donor Reduced Intensity Bone Marrow Transplant for Children with Severe Sickle Cell Disease / The SCURT Study
• Protocol (PDF)
• Informed Consent and Assent 
• Frequently Asked Questions
• Key Personnel
  • BMT CTN # 0601 Protocol co-Chair: Shalini Shenoy, MD
  • BMT CTN # 0601 Protocol co-Chair: Naynesh Kamani  
  • BMT CTN # 0601 Protocol Officer: Mary Eapen, MD
  • BMT CTN # 0601 Protocol Coordinator: bmtctn@emmes.com
  • BMT CTN # 0601 Medical Monitor: Angela Smith, MD
• Keywords: Sickle Cell, Sickle Cell Disease, SCD, Reduced Intensity, Bone Marrow, Unrelated, Unrelated Donor, Allogeneic Transplant, Allo Transplant, Allo, SCURT, Quality of Life, QOL, Pediatric, Child, Children, Teen, Adolescent

• Protocol Short Name and Number: NST for Elderly AML, 0502
• Protocol Long Name: A Phase II Study of Allogeneic Transplant for Older Patients with AML in First Morphologic Complete Remission using a Non-myeloblative Preparative Regimen
• Protocol (PDF)
• Protocol Synopsis/Schema (PDF)
• Informed Consents (PDF)
• Key Personnel
  • BMT CTN # 0502 Protocol Chair: Steven Devine, MD  
  • BMT CTN # 0502 BMT CTN Protocol Chair: Sergio Giralt, MD
  • Alliance Regulatory Group: regulatory@alliancenctn.org
• Keywords: Allo Transplant, Allogeneic Transplant, Allo, Unrelated, Unrelated Donor, Acute Myelogenous Leukemia, AML

Patient accrual on CALGB 100103/BMT CTN 0502 closed on December 29, 2011.

• Protocol Short Name and Number: Cord Blood, 0501
• Protocol Long Name: Multi-center, Open Label, Randomized Trial Comparing Single Versus Double Umbilical Cord Blood (UCB) Transplantation in Pediatric Patients with Leukemia and Myelodysplasia
• Protocol (PDF)
• Consent and Assent Forms
• Frequently Asked Questions
• Key Personnel
  • BMT CTN # 0501 Protocol Co-Chair: John Wagner, MD  
  • BMT CTN # 0501 Protocol Co-Chair: Joanne Kurtzberg, MD  
  • BMT CTN # 0501 Protocol Officer: Mary Eapen, MD
  • BMT CTN # 0501 Medical Monitor: Dianna Howard, MD  
  • BMT CTN # 0501 Protocol Coordinator:  bmtctn@emmes.com
• Keywords: Cord blood, UCB, Umbilical Cord Blood, Pediatric, Leukemia, Myelodysplastic Syndrome, MDS, Allo Transplant, Allogeneic Transplant, Allo, Child, Children, Teen, Adolescent

BMT CTN Protocol #0501 closed to patient accrual on February 29, 2012.

• Protocol Short Name and Number: Etanercept IPS, 0403
• Protocol Long Name: A Phase III, Randomized Double-Blind, Placebo Controlled Trial of Soluble Tumor Necrosis Factor Receptor: Enbrel (Etanercept) for the Treatment of Acute Non-Infectious Pulmonary Dysfunction (Idiopathic Pneumonia Syndrome) Following Allogeneic Stem Cell Transplantation
• Protocol (PDF)
• Informed Consent 
• Frequently Asked Questions
• Key Personnel
  • BMT CTN # 0403 Protocol Co-Chair: Ken Cooke, MD  
  • BMT CTN # 0403 Protocol Co-Chair: Greg Yanik, MD
  • BMT CTN # 0403 Protocol Officer: Mary Horowitz, MD
  • BMT CTN # 0403 Medical Monitor: Marcie Riches, MD
  • BMT CTN # 0403 Protocol Coordinator:  bmtctn@emmes.com
• Keywords: Etanercept, Enbrel, Idiopathic Pneumonia Syndrome, IPS

BMT CTN Protocol #0403 closed to patient accrual on September 14, 2011.

• Protocol Short Name and Number: GVHD Prophylaxis, 0402
• Protocol Long Name: A Phase III Randomized, Multicenter Trial Comparing
  Sirolimus/Tacrolimus with Tacrolimus/Methotrexate as GVHD Prophylaxis After HLA-Matched, Related Peripheral Blood Stem Cell Transplantation
• Protocol (PDF)
• Consent Forms (PDF)
• Frequently Asked Questions
• Key Personnel
  • BMT CTN # 0402 Protocol Co-Chair: Joseph Antin, MD
  • BMT CTN # 0402 Protocol Co-Chair: Corey Cutler, MD  
  • BMT CTN # 0402 Protocol Officer: Marcelo Pasquini, MD  
  • BMT CTN # 0402 Medical Monitor: Mary Eapen, MD
  • BMT CTN # 0402 Protocol Coordinator:  bmtctn@emmes.com
• Keywords: Graft versus Host Disease, GVHD, Graft vs. Host Disease, Allogeneic Transplant, Allo Transplant, Allo, Prophylaxis, Pediatric, Leukemia, Myelodysplastic Syndrome, Child, Children, Teen, Adolescent

This study closed to patient accrual on October 28, 2011.

• Protocol Short Name and Number: Bexxar/BEAM,0401
• Protocol Long Name: Phase III Rituxan/BEAM vs. Bexxar/BEAM with Autologous Hematopoietic Stem Cell Transplantation (ASCT) for Persistent or Relapsed Chemotherapy Sensitive Diffuse Large B-Cell Non-Hodgkin’s Lymphoma
• Protocol (PDF)
• Informed Consent
• Frequently Asked Questions
• Key Personnel
  • BMT CTN # 0401 Protocol Chair: Julie Vose, MD
  • BMT CTN # 0401 Protocol Officer: Marcie Tomblyn, MD
  • BMT CTN # 0401 Medical Monitor: Eneida Nemecek, MD
  • BMT CTN # 0401 Protocol Coordinator:  bmtctn@emmes.com
• Keywords: Bexxar, BEAM, Rituxan, Autologous Transplant, Auto Transplant, Auto, B-cell Lymphoma, Lymphoma, DLCBL

This study reached target accrual and closed to patient accrual on July 17, 2009.

• Protocol Short Name and Number: AML T-cell Depletion, 0303
• Protocol Long Name: A Single Arm, Multicenter Phase II Trial of Transplants of HLA-Matched, CD34+ Enriched, T cell Depleted Peripheral Blood Stem Cells Isolated by the CliniMACS System in the Treatment of Patients with AML in First or Second Morphologic Complete Remission
• Protocol (PDF)
• Informed Consents 
• Frequently Asked Questions
• Key Personnel
  • BMT CTN # 0303 Protocol Co-Chair: Richard O’Reilly, MD  
  • BMT CTN # 0303 Protocol Co-Chair: Steve Devine, MD  
  • BMT CTN # 0303 Protocol Officer: Marcelo Pasquini, MD  
  • BMT CTN # 0303 Protocol Coordinator: bmtctn@emmes.com
  • BMT CTN # 0303 Medical Monitor: Marcie Riches, MD
• Keywords: Acute Myelogenous Leukemia, AML, CD34+, CD34, CliniMACS, T-cell Depleted, Allo Transplant, Allogeneic Transplant, Allo

This study met its target enrollment and closed accrual on January 11, 2009.

• Protocol Short Name and Number: Acute GVHD, 0302
• Protocol Long Name: Initial Systemic Treatment of Acute GVHD: A Phase II Randomized Trial Evaluating Etanercept, Mycophenolate Mofetil (MMF), Denileukin Diftitox (Ontak), and Pentostatin in Combination with Corticosteroids
• Protocol (PDF)
• Consent Forms
• Frequently Asked Questions
• Key Personnel
  • BMT CTN # 0302 Protocol Chair: Dan Weisdorf, MD
  • BMT CTN # 0302 Protocol Officer: Marcelo Pasquini, MD  
  • BMT CTN # 0302 Medical Monitor: Mary Eapen, MD
  • BMT CTN # 0302 Protocol Coordinator:  bmtctn@emmes.com
• Keywords: Etanercept, Mycophenolate Mofetil, MMF, Denileukin Diftitox (Ontak), Pentostatin, Treatment, Pediatric, Graft versus Host Disease, GVHD, Graft vs. Host Disease, Child, Children, Teen, Adolescent

The BMT CTN #0302 study met its target accrual of 180 patients and closed enrollment on March 24, 2008.

• Protocol Short Name and Number: Aplastic Anemia, 0301
• Protocol Long Name: Fludarabine-based Conditioning for Allogeneic Marrow Transplantation from HLA-compatible Unrelated Donors in Severe Aplastic Anemia
• Protocol (PDF)
• Informed Consent
• Frequently Asked Questions
• Key Personnel
  • BMT CTN # 0301 Protocol Chair:  Paolo Anderlini, MD  
  • BMT CTN # 0301 Protocol Officer:  Mary Eapen, MD  
  • BMT CTN # 0301 Protocol Statistician: Adam Mendizabal, PhD  
  • BMT CTN # 0301 Protocol Coordinator: bmtctn@emmes.com
  • BMT CTN # 0301 Medical Monitor: Chris Bredeson, MD
• Keywords: Aplastic Anemia, AA, Severe Aplastic Anemia, SAA, Unrelated, Unrelated Donor, Allogeneic Transplant, Allo Transplant, Allo, Pediatric, Child, Children, Teen, Adolescent

This study reached target accrual and was closed to patient accruals on December 2, 2013.

• Protocol Short Name and Number: Follicular Lymphoma, 0202
• Protocol Long Name: Autologous vs. Non-Myeloablative Allogeneic Hematopoietic Stem Cell  Transplantation (HSCT) for Patients with Chemosensitive Follicular Non-Hodgkin’s  Lymphoma Beyond First Complete Response or First Partial Response
• Protocol (PDF)
• Informed Consents
• Frequently Asked Questions
• Key Personnel
  • BMT CTN # 0202  Protocol Co-Chair: Ginna Laport, MD  
  • BMT CTN # 0202  Protocol Co-Chair: Robert Negrin, MD  
  • BMT CTN # 0202  Protocol Officer:  Marcie Tomblyn, MD
  • BMT CTN # 0202  Protocol Medical Monitor: Mary Eapen, MD
  • BMT CTN # 0202  Protocol Coordinator:  bmtctn@emmes.com
• Keywords: Lymphoma, Follicular, Non-Hodgkin’s Lymphoma, NHL, Autologous Transplant, Auto Transplant, Auto, Allo Transplant, Allogeneic Transplant, Allo, Pediatric, Quality of Life, QOL, Non-myeloablative, Child, Children, Teen, Adolescent

This protocol closed to patient accrual on March 2, 2006.

• Protocol Short Name and Number: URD PB vs B, 0201
• Protocol Long Name: A Phase III Randomized Multicenter Trial Comparing G-CSF Mobilized Peripheral Blood Stem Cell with Marrow Transplantation from HLA Compatible Unrelated Donors
• Protocol (PDF)
• Informed Consents Forms
• Key Personnel
  • BMT CTN # 0201 Protocol Chair:  Claudio Anasetti, MD
  • BMT CTN # 0201 Protocol Officer:  Dennis Confer, MD
  • BMT CTN # 0201 Medical Monitor: Chris Bredeson, MD
  • ADD BMT CTN # 0201 Protocol Coordinator: bmtctn@emmes.com
• Keywords: Unrelated, Unrelated Donor, Allogeneic Transplant, Allo Transplant, Allo, PBSC, Peripheral Blood Stem Cell, Bone Marrow, Pediatric, Leukemia, Myelodysplastic Syndrome, MDS, Myeloproliferative Disorders, Quality of Life, QOL, Child, Children, Teen, Adolescent

The BMT CTN #0201 study met its target accrual of 550 patients and closed enrollment on September 9, 2009.

• Protocol Short Name and Number: Multiple Myeloma, 0102
• Protocol Long Name: A Trial of Tandem Autologous Stem Cell Transplants +/- Post Second Autologous Transplant Maintenance Therapy versus Single Autologous Stem Cell Transplant Followed by Matched Sibling Non-myeloablative Allogeneic Stem Cell Transplant for Patients with Multiple Myeloma
• Protocol (PDF)
• Informed Consent Forms (.zip)
• Key Personnel
  • BMT CTN # 0102 Protocol Co-Chair: David Maloney, MD
  • BMT CTN # 0102 Protocol Co-Chair:  Amrita Krishnan, MD
  • BMT CTN # 0102 Protocol Officer:  Marcelo Pasquini, MD  
  • BMT CTN # 0102 Medical Monitor: Marcelo Pasquini, MD  
  • BMT CTN # 0102 Protocol Coordinator:  bmtctn@emmes.com
• Keywords: Multiple Myeloma, MM, Tandem, Auto Transplant, Autologous Transplant, Auto, Allo Transplant, Allogeneic Transplant, Allo, Non-Myeloablative, Quality of Life, QOL

This study reached the target accrual and closed to patient accrual on March 30, 2007.

• Protocol Short Name and Number: Fungal Prophylaxis, 0101
• Protocol Long Name: A Randomized Double-blind Trial of Fluconazole vs. Voriconazole for the Prevention of Invasive Fungal Infections in Allogeneic Blood and Marrow Transplant Recipients
• Protocol (PDF)
• Informed Consent Forms
• BMT CTN 0101 IFI Cost Calculator 
• Key Personnel
  • BMT CTN # 0101 Protocol Chair:  John Wingard, MD  
  • BMT CTN # 0101 Protocol Officer:  Dennis Confer, MD
  • BMT CTN # 0101 Medical Monitor:  Marcelo Pasquini, MD
  • BMT CTN # 0101 Protocol Coordinator: bmtctn@emmes.com
• Keywords: Fungal Prophylaxis, Fluconazole, Voriconazole, Allo Transplant, Allogeneic Transplant, Allo, Pediatric, Galactomannan, Child, Children, Teen, Adolescent

This study reached target accrual and closed to patient accrual on September 21,2006.