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NCT03279094 · ClinicalTrials.gov registry record · Phase 1
Haploidentical Transplantation With Pre-Transplant Immunosuppressive Therapy for Patients With Sickle Cell Disease
A Phase 1 study of Sickle Cell Disease, sponsored by City of Hope Medical Center.
- Active
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
- 1
- Study location
NCT03279094: Active Phase 1 study of Sickle Cell Disease, sponsored by City of Hope Medical Center.
NCT03279094 is a Phase 1 study of Sickle Cell Disease that is active but no longer recruiting, run by City of Hope Medical Center. The registered enrollment target is 11 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
NCT03279094, a Phase 1 study of Sickle Cell Disease, is active but no longer recruiting, sponsored by City of Hope Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a study to evaluate the safety and toxicity of a treatment regimen consisting of 2 cycles of pre-transplant immunosuppressive therapy followed by myeloablative preparative regimen and allogeneic hematopoietic stem cell transplantation from a haploidentical donor in patients with sickle cell disease. The overall goal of this study is to expand the donor pool for hematopoietic stem cell transplantation in sickle cell disease using haploidentical donors, and to develop a non-toxic, myeloablative regimen, with the goal of achieving a consistent donor chimerism utilizing pre-transplant immunosuppressive therapy.
Primary Outcome
* Rate of death of any causes * Rate of study discontinuation or early withdrawal * Rate of graft failure • Primary graft failure is defined as failure to achieve a neutrophil count of 0.5 x 109/L before day +42 or mixed chimerism with failure to achieve \<30% Hgb S on electrophoresis after day +180. Secondary graft failure is defined as recovery followed by a sustained loss of initial graft. * Rate of grade 4 non-hematological toxicities per NCI CTCAE v4.03 that last more than 21 days
Conditions Studied
Interventions
- BIOLOGICAL Hematopoietic stem cell transplantation
Study Locations (1)
California
- City of Hope Medical Center - Duarte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2018-02-02 |
| Est. Completion | 2026-02-24 |
| Phase | Phase 1 |
What the registry record for NCT03279094 still lists
NCT03279094 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 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 1 intervention - of which Hematopoietic stem cell transplantation is the first listed.
NCT03279094 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT03279094 about?
NCT03279094 is a clinical study titled "Haploidentical Transplantation With Pre-Transplant Immunosuppressive Therapy for Patients With Sickle Cell Disease". This is a study to evaluate the safety and toxicity of a treatment regimen consisting of 2 cycles of pre-transplant immunosuppressive therapy followed by myeloablative preparative regimen and allogeneic hematopoietic stem cell transplantation from a haploidentical donor in patients with sickle cell ...
What is the current status of trial NCT03279094?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2018-02-02. Estimated completion is 2026-02-24.
What conditions does trial NCT03279094 study?
This clinical trial studies the following conditions: Sickle Cell Disease.
What interventions are being tested in trial NCT03279094?
The interventions under investigation include: Hematopoietic stem cell transplantation (BIOLOGICAL).
Who is sponsoring clinical trial NCT03279094?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03279094 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03279094's enrollment target sits among peer trials
11 195th of 213 higher than 19 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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