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NCT07616154 · ClinicalTrials.gov registry record · Phase 2
Haploidentical Donor Hematopoietic Cell Transplant for Sickle Cell Disease
A Phase 2 study, sponsored by St. Jude Children's Research Hospital.
- Not yet
- Registry status
- Phase 2
- Development phase
- 45
- Enrollment target
NCT07616154: Clinical Trial Phase 2 study, sponsored by St. Jude Children's Research Hospital.
NCT07616154 is a Phase 2 study that has not yet begun recruiting, run by St. Jude Children's Research Hospital. The registered enrollment target is 45 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (66% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07616154, a Phase 2 study, has not yet begun recruiting, sponsored by St. Jude Children's Research Hospital.
- NOT YET RECRUITING
- Registry status
- Phase 2
- Development phase
- 45 participants
- Enrollment target
Study Summary
The purpose of this study it to evaluate a reduced toxicity conditioning regimen for haploidentical donor HCT followed by a GVHD prophylaxis regimen comprising of post-transplant cyclophosphamide, sirolimus and abatacept with the goal to improve the GVHD-free rejection-free survival (GRFS) to greater than 90% after haploidentical donor HCT in children and young adults with SCD. Primary Objective: \- To assess the GVHD-free and rejection free survival (GRFS) after haploidentical donor HCT in children and young adults with SCD. Secondary Objectives: * Assess the overall survival (OS) and disease-free survival (DFS) after haploidentical donor HCT for SCD. * Estimate incidence and severity of acute and chronic GVHD after haploidentical donor HCT for SCD. * Assess the neutrophil and platelet engraftment kinetics after haploidentical donor HCT for SCD.
Primary Outcome
GRFS is defined as the time interval from transplant (graft infusion) until the first of grade III-IV acute GVHD, moderate or severe chronic GVHD, primary or secondary graft failure requiring second definitive therapy, and death occurs. GRFS will be calculated at 1-year, and 3-year post-transplant and reported as a percentage of the enrolled patients.
Interventions
- DRUG Alemtuzumab
- DRUG Hydroxyurea
- DRUG Abatacept
- DRUG Thiotepa
- DRUG Cyclophosphamide 50mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2026-09 |
| Est. Completion | 2035-09 |
| Phase | Phase 2 |
What is known before NCT07616154 opens enrollment
NCT07616154 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (66% lower).
The record links to 0 conditions, and to 5 interventions - of which Alemtuzumab is the first listed.
NCT07616154 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07616154 about?
NCT07616154 is a clinical study titled "Haploidentical Donor Hematopoietic Cell Transplant for Sickle Cell Disease". The purpose of this study it to evaluate a reduced toxicity conditioning regimen for haploidentical donor HCT followed by a GVHD prophylaxis regimen comprising of post-transplant cyclophosphamide, sirolimus and abatacept with the goal to improve the GVHD-free rejection-free survival (GRFS) to greate...
What is the current status of trial NCT07616154?
This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 45 participants. The study started on 2026-09. Estimated completion is 2035-09.
What interventions are being tested in trial NCT07616154?
The interventions under investigation include: Alemtuzumab (DRUG), Hydroxyurea (DRUG), Abatacept (DRUG), Thiotepa (DRUG), Cyclophosphamide 50mg (DRUG).
Who is sponsoring clinical trial NCT07616154?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07616154's enrollment target sits among peer trials
45 1296th of 2000 higher than 679 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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