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NCT06358638 · ClinicalTrials.gov registry record · Phase 2
Sickle Cell Disease Transplant Using a Nonmyeloablative Approach for Patients With Anti-donor Red Cell Antibody
A Phase 2 study of Sickle Cell Disease, sponsored by Children's National Research Institute.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT06358638: Recruiting Phase 2 study of Sickle Cell Disease, sponsored by Children's National Research Institute.
NCT06358638 is a Phase 2 study of Sickle Cell Disease that is actively recruiting participants, run by Children's National Research Institute. The registered enrollment target is 12 participants, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06358638, a Phase 2 study of Sickle Cell Disease, is actively recruiting participants, sponsored by Children's National Research Institute.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
This multicenter prospective study seeks to determine if daratumumab given, prior to HLA-identical sibling donor transplantation using alemtuzumab, low dose total-body irradiation, and sirolimus, can prevent pure red blood cell aplasia with an acceptable safety profile in patients with anti-donor red blood cell antibodies, achieving an event-free survival similar to transplanted patients without such antibodies.
Primary Outcome
Event-free survival rate at 1 year with events including death, graft failure (donor myeloid chimerism \<10% or second HCT), grade II-IV GVHD, and serious pure red blood cell aplasia (persistent reticulocytopenia and need for red blood cell transfusion support after day +100).
Conditions Studied
Interventions
- DRUG Sirolimus
- DRUG Alemtuzumab
- DRUG Daratumumab
- RADIATION Total Body Irradiation
Study Locations (1)
District of Columbia
- Children's National Hospital - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2024-04-03 |
| Est. Completion | 2054-09 |
| Phase | Phase 2 |
What NCT06358638 shows while recruiting
NCT06358638 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Sickle Cell Disease appearing as the primary indexed condition, and to 4 interventions - of which Sirolimus is the first listed.
NCT06358638 reports a single indexed study location in District of Columbia.
Frequently Asked Questions
What is clinical trial NCT06358638 about?
NCT06358638 is a clinical study titled "Sickle Cell Disease Transplant Using a Nonmyeloablative Approach for Patients With Anti-donor Red Cell Antibody". This multicenter prospective study seeks to determine if daratumumab given, prior to HLA-identical sibling donor transplantation using alemtuzumab, low dose total-body irradiation, and sirolimus, can prevent pure red blood cell aplasia with an acceptable safety profile in patients with anti-donor re...
What is the current status of trial NCT06358638?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2024-04-03. Estimated completion is 2054-09.
What conditions does trial NCT06358638 study?
This clinical trial studies the following conditions: Sickle Cell Disease.
What interventions are being tested in trial NCT06358638?
The interventions under investigation include: Sirolimus (DRUG), Alemtuzumab (DRUG), Daratumumab (DRUG), Total Body Irradiation (RADIATION).
Who is sponsoring clinical trial NCT06358638?
This trial is sponsored by Children's National Research Institute, which has 92 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06358638 being conducted?
This trial has 1 study location across District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Sickle Cell Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06358638's enrollment target sits among peer trials
12 193rd of 213 higher than 20 of 213 other Sickle Cell Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sickle Cell Disease 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.
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