Correlative Study Proposals
Ancillary Study Proposal Submissions and Approval Process
- Ancillary Study Review & Approval Process Summary
- Ancillary Study Proposal Utilizing Biospecimens
Submit completed form by email to bmtctn_nmdp@nmdp.org.
Data for Secondary Analyses Resources
A “secondary analysis” is defined as a study that uses previously collected data from BMT CTN studies to look at objectives other than those addressed in the original studies. Additional information may be found on the BMT CTN Administrative MOP page.
To request data support, please download the Secondary Analysis Proposal Form to complete and submit to bmtctnstat@emmes.com. Data will be provided only after the proposal is approved. The review and approval process are described in the BMT CTN MOP.
BMT CTN Research Sample Collections
The BMT CTN supports investigators engaged in retrospective immunogenetic and immunobiological studies in Hematopoietic cell transplantation (HCT) / Cellular Therapy (CT) by providing access to numerous research samples and clinical data collected during our BMT CTN clinical trials. Protocol-specific links provide investigators with the following resources:
- Clinical protocols to review primary and secondary endpoints and other relevant clinical data collected in each trial.
- Information regarding the prospective collection schedule for research samples, sample processing, and sample storage parameters.
- Protocol-specific research sample collection summaries to facilitate initial assessments of available research samples for future ancillary study planning.
- Overview of BMT CTN procedures for reviewing and approving ancillary study proposals and current proposal submission form.
| BMT CTN 0101 |
A Randomized Double-blind Trial of Fluconazole vs. Voriconazole for the Prevention of Invasive Fungal Infections in Allogeneic Blood and Marrow Transplant Recipients NHLBI “Open Period” Status – NHLBI Repository: All inquiries for information regarding the availability of research samples and for clinical outcome data requests should be directed to the NHLBI by going to the following BioLINCC website page: https://biolincc.nhlbi.nih.gov/studies/bmtctn0101 |
| BMT CTN 0102 |
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 NHLBI “Open Period” Status – NHLBI Repository: All inquiries for information regarding the availability of research samples and for clinical outcome data requests should be directed to the NHLBI by going to the following BioLINCC website page: https://biolincc.nhlbi.nih.gov/studies/bmtctn0102 |
| BMT CTN 0201 |
A Phase III Randomized Multicenter Trial Comparing G-CSF Mobilized Peripheral Blood Stem Cell with Marrow Transplantation from HLA Compatible Unrelated Donors NHLBI “Open Period” Status – NHLBI Repository: All inquiries for information regarding the availability of research samples and for clinical outcome data requests should be directed to the NHLBI by going to the following BioLINCC website page: https://biolincc.nhlbi.nih.gov/studies/bmtctn0201 Donor Samples: This study also has a collection of donor specimens that are made available through the BMT CTN Repository.
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| BMT CTN 0302 |
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
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| BMT CTN 0401 |
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
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| BMT CTN 0402 |
A Phase III Randomized, Multicenter Trial Comparing Sirolimus/Tacrolimus with Tacrolimus/Methotrexate as GVHD Prophylaxis After HLA-Matched, Related Peripheral Blood Stem Cell Transplantation NHLBI “Open Period” Status – NHLBI Repository: All inquiries for information regarding the availability of research samples and for clinical outcome data requests should be directed to the NHLBI by going to the following BioLINCC website page: https://biolincc.nhlbi.nih.gov/studies/bmtctn0402/?q=0402 |
| BMT CTN 0701 |
Phase II Trial of Non-Myeloablative Allogeneic Hematopoietic Cell Transplantation for Patients with Relapsed Follicular Non-Hodgkin’s Lymphoma Beyond First Complete Response
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| BMT CTN 0702 |
A Trial of Single Autologous Transplant with or without Consolidation Therapy versus Tandem Autologous Transplant with Lenalidomide Maintenance for Patients with Multiple Myeloma
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| BMT CTN 07LT |
Continued, Long-Term Follow-Up and Lenalidomide Maintenance Therapy for Patients Who Have Enrolled on BMT CTN 0702
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| BMT CTN 0801 |
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
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| BMT CTN 0802 |
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
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| BMT CTN 0803 |
High Dose Chemotherapy with Autologous Stem Cell Rescue for Aggressive B Cell Lymphoma and Hodgkin Lymphoma in HIV-infected Patients ACSR Repository Biospecimen Collection: All inquiries for information regarding the availability of BMT CTN 0803 (AMC-071) research samples and associated clinical outcome data request should be directed to the AIDS and Cancer Specimen Resource Repository by going to the following ACSR website page: https://acsr.ucsf.edu |
| BMT CTN 0901 |
A Randomized, Multi-Center, Phase III Study of Allogeneic Stem Cell Transplantation Comparing Regimen Intensity in Patients with Myelodysplastic Syndrome or Acute Myeloid Leukemia
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| BMT CTN 0903 |
Allogeneic Hematopoietic Cell Transplant for Hematological Cancers and Myelodysplastic Syndromes in HIV-infected Patients ACSR Repository Biospecimen Collection: All inquiries for information regarding the availability of BMT CTN 0903 (AMC-080) research samples and associated clinical outcome data request should be directed to the AIDS and Cancer Specimen Resource Repository by going to the following ACSR website page: https://acsr.ucsf.edu |
| BMT CTN 1101 |
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
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| BMT CTN 1102 |
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
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| BMT CTN 1202 |
Prospective Multi-Center Cohort for the Evaluation of Biomarkers Predicting Risk of Complications and Mortality Following Allogeneic HCT
CIBMTR-NMDP Research Sample Repository Sample Collection (Pre-Transplant Patient and Donor Samples Associated with BMT CTN 1202):
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| BMT CTN 1203 |
A Multi-Center Phase II Trial Randomizing Novel Approaches for Graft-versus-Host Disease Prevention Compared to Contemporary Controls
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| BMT CTN 1204 |
Reduced-Intensity Conditioning for Children and Adults with Hemophagocytic Syndromes or Selected Primary Immune Deficiencies (RICHI)
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| BMT CTN 1301 |
A Randomized, Multi-Center, Phase III Trial of Calcineurin Inhibitor-Free Interventions for Prevention of Graft-versus-Host Disease
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| BMT CTN 1302 |
Multicenter Phase II, Double-blind Placebo Controlled Trial of Maintenance Ixazomib after Allogeneic Hematopoietic Stem Cell Transplantation for High Risk Multiple Myeloma
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| BMT CTN 1401 |
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
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| BMT CTN 1501 |
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
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| BMT CTN 1502 |
Optimizing Haploidentical Aplastic Anemia Transplantation (CHAMP)
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| BMT CTN 1703/1801 |
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
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| BMT CTN 2101 |
A 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
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