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NCT02678143 · ClinicalTrials.gov registry record · Phase 1
Nonmyeloablative Conditioning for Mismatched Hematopoietic Stem Cell Transplantation for Severe Sickle Cell Disease
A Phase 1 study, sponsored by Washington University School of Medicine.
- Terminated
- Registry status
- Phase 1
- Development phase
- 1
- Enrollment target
NCT02678143: Clinical Trial Phase 1 study, sponsored by Washington University School of Medicine.
NCT02678143 is a Phase 1 study that was terminated before completion, run by Washington University School of Medicine. The registered enrollment target is 1 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02678143, a Phase 1 study, was terminated before completion, sponsored by Washington University School of Medicine.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 1 participants
- Enrollment target
Study Summary
The aim of this study is to evaluate the overall safety and feasibility of using haploidentical or one antigen mismatch unrelated hematopoietic stem cell transplant (HSCT) for adult patients with severe sickle cell disease (SCD) who undergo a non-myeloablative preparative regimen consisting of total body irradiation (TBI), cyclophosphamide and alemtuzumab (and fludarabine for haplo-SCT only) and graft vs. host disease (GvHD) prophylaxis consisting of post-transplant cyclophosphamide (PT-Cy), mycophenolate mofetil (MMF), and sirolimus. The investigators anticipate that this approach will expand the donor pool and offer a safe and less toxic curative intervention.
Primary Outcome
-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Sirolimus
- DRUG Alemtuzumab
- DRUG Mycophenolate mofetil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2016-04-26 |
| Est. Completion | 2021-11-16 |
| Phase | Phase 1 |
Why NCT02678143 stopped before completion
NCT02678143 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT02678143 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02678143 about?
NCT02678143 is a clinical study titled "Nonmyeloablative Conditioning for Mismatched Hematopoietic Stem Cell Transplantation for Severe Sickle Cell Disease". The aim of this study is to evaluate the overall safety and feasibility of using haploidentical or one antigen mismatch unrelated hematopoietic stem cell transplant (HSCT) for adult patients with severe sickle cell disease (SCD) who undergo a non-myeloablative preparative regimen consisting of total...
What is the current status of trial NCT02678143?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2016-04-26. Estimated completion is 2021-11-16.
What interventions are being tested in trial NCT02678143?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Sirolimus (DRUG), Alemtuzumab (DRUG), Mycophenolate mofetil (DRUG).
Who is sponsoring clinical trial NCT02678143?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02678143's enrollment target sits among peer trials
1 2001st of 2000 the lowest of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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