Haploidentical Bone Marrow Transplantation in Sickle Cell Patients (BMTCTN1507)
Reduced Intensity Conditioning for Haploidentical Bone Marrow Transplantation in Patients With Symptomatic Sickle Cell Disease. (BMTCTN1507)
Sponsor: Blood and Marrow Transplant Clinical Trials Network
This observational or N/A phase trial investigates Sickle Cell Disease and is currently completed. Blood and Marrow Transplant Clinical Trials Network leads this study, which shows 23 recorded versions since 2017 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.
Study Description(click to expand)This study is designed as a Phase II multi-center trial to determine the feasibility of achieving a high rate of event-free survival (EFS) at 2 years post transplant using pre-conditioning hydroxyurea (HU) with a conditioning regimen that consists of a combination of Thymoglobulin/Cyclophosphamide/Fludarabine/Thiotepa with post-grafting high-dose cyclophosphamide in patients with severe SCD who have HLA-haploidentical donors. EFS is defined as survival without a qualifying event. This is a single arm study in which participants will be enrolled into one of two strata. The first stratum will be restricted to children who have stroke and 40 children will be enrolled in this stratum. The second stratum will consist of adult patients with severe sickle cell disease and 40 participants will be enrolled in this stratum.
This study is designed as a Phase II multi-center trial to determine the feasibility of achieving a high rate of event-free survival (EFS) at 2 years post transplant using pre-conditioning hydroxyurea (HU) with a conditioning regimen that consists of a combination of Thymoglobulin/Cyclophosphamide/Fludarabine/Thiotepa with post-grafting high-dose cyclophosphamide in patients with severe SCD who have HLA-haploidentical donors. EFS is defined as survival without a qualifying event. This is a single arm study in which participants will be enrolled into one of two strata. The first stratum will be restricted to children who have stroke and 40 children will be enrolled in this stratum. The second stratum will consist of adult patients with severe sickle cell disease and 40 participants will be enrolled in this stratum.
Status Flow
Change History
23 versions recorded-
May 4, 2026 — Present [daily]
Completed
Phase: PHASE2 → None
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Sep 2025 — May 2026 [monthly]
Completed PHASE2
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May 2025 — Sep 2025 [monthly]
Completed PHASE2
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Mar 2025 — May 2025 [monthly]
Completed PHASE2
Status: Active Not Recruiting → Completed
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Sep 2024 — Mar 2025 [monthly]
Active Not Recruiting PHASE2
▶ Show 18 earlier versions
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Jul 2024 — Sep 2024 [monthly]
Active Not Recruiting PHASE2
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Jan 2024 — Jul 2024 [monthly]
Active Not Recruiting PHASE2
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Jan 2023 — Jan 2024 [monthly]
Active Not Recruiting PHASE2
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Nov 2022 — Jan 2023 [monthly]
Active Not Recruiting PHASE2
Status: Recruiting → Active Not Recruiting
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Feb 2022 — Nov 2022 [monthly]
Recruiting PHASE2
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Jan 2022 — Feb 2022 [monthly]
Recruiting PHASE2
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Dec 2021 — Jan 2022 [monthly]
Recruiting PHASE2
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Nov 2021 — Dec 2021 [monthly]
Recruiting PHASE2
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Sep 2021 — Nov 2021 [monthly]
Recruiting PHASE2
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Jan 2021 — Sep 2021 [monthly]
Recruiting PHASE2
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Jun 2020 — Jan 2021 [monthly]
Recruiting PHASE2
Status: Active Not Recruiting → Recruiting
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May 2020 — Jun 2020 [monthly]
Active Not Recruiting PHASE2
Status: Recruiting → Active Not Recruiting
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Feb 2020 — May 2020 [monthly]
Recruiting PHASE2
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Jul 2018 — Feb 2020 [monthly]
Recruiting PHASE2
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Jun 2018 — Jul 2018 [monthly]
Recruiting PHASE2
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Mar 2018 — Jun 2018 [monthly]
Recruiting PHASE2
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Dec 2017 — Mar 2018 [monthly]
Recruiting PHASE2
Status: Not Yet Recruiting → Recruiting
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Sep 2017 — Dec 2017 [monthly]
Not Yet Recruiting PHASE2
First recorded
Eligibility Summary
This is a Phase II, single arm, multi-center trial, designed to estimate the efficacy and toxicity of haploidentical bone marrow transplantation (BMT) in patients with sickle cell disease (SCD). Based on their age and entry criteria patients are stratified into two groups: (1) children with severe SCD; and (2) adults with severe SCD.
Contact Information
- Blood and Marrow Transplant Clinical Trials Network
- Medical College of Wisconsin
- National Cancer Institute (NCI)
- National Heart, Lung, and Blood Institute (NHLBI)
- National Marrow Donor Program
For direct contact, visit the study record on ClinicalTrials.gov .