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NCT02867800 · ClinicalTrials.gov registry record · Phase 1
Abatacept for GVHD Prophylaxis After Hematopoietic Stem Cell Transplantation for Pediatric Sickle Cell Disease
A Phase 1 study of Sickle Cell Disease and Graft-Versus-Host Disease, sponsored by Monica Bhatia.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 7
- Study locations
NCT02867800: Completed Phase 1 study of Sickle Cell Disease and Graft-Versus-Host Disease, sponsored by Monica Bhatia.
NCT02867800 is a Phase 1 study of Sickle Cell Disease and Graft-Versus-Host Disease that has completed, run by Monica Bhatia. The registered enrollment target is 24 participants, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (92% lower). The trial reports 7 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02867800, a Phase 1 study of Sickle Cell Disease and Graft-Versus-Host Disease, has completed, sponsored by Monica Bhatia.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 7
- Study locations
Study Summary
To assess the tolerability of the costimulation blocking agent abatacept (CTLA4-Ig) when added to the standard graft versus host disease (GVHD) prophylaxis regimen of a calcineurin inhibitor and methotrexate in patients receiving early alemtuzumab followed by fludarabine, thiotepa, melphalan, and alemtuzumab for conditioning.
Primary Outcome
Patients will be deemed to be evaluable for tolerability if they received all prescribed doses of abatacept. Abatacept will deemed to be tolerated, if no more than one dose is withheld per protocol stipulations, no death from an infection that occurs within 30 days of or develops post-transplant lymphoproliferative disease (PTLD) within 100 days of receiving the last prescribed dose of abatacept.
Conditions Studied
Interventions
- DRUG Acetaminophen
- DRUG Alemtuzumab
- DRUG Methylprednisolone
- DRUG Diphenhydramine
- DRUG Meperidine
Study Locations (7)
District of Columbia
- Children's National Medical Center - Washington D.C.
Georgia
- Children's Healthcare of Atlanta - Atlanta
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago - Chicago
Massachusetts
- Floating Hospital for Children at Tufts Medical Center - Boston
New York
- Columbia University Irving Medical Center - New York
North Carolina
- North Carolina Cancer Hospital - Chapel Hill
Ohio
- Nationwide Children's Hospital - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2016-07 |
| Est. Completion | 2023-12-30 |
| Phase | Phase 1 |
What the finished NCT02867800 record still lists
NCT02867800 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (92% lower).
The record links to 2 conditions, with Sickle Cell Disease appearing as the primary indexed condition, and to 5 interventions - of which Acetaminophen is the first listed.
NCT02867800 lists 7 locations in 7 states (District of Columbia, Georgia, Illinois).
Frequently Asked Questions
What is clinical trial NCT02867800 about?
NCT02867800 is a clinical study titled "Abatacept for GVHD Prophylaxis After Hematopoietic Stem Cell Transplantation for Pediatric Sickle Cell Disease". To assess the tolerability of the costimulation blocking agent abatacept (CTLA4-Ig) when added to the standard graft versus host disease (GVHD) prophylaxis regimen of a calcineurin inhibitor and methotrexate in patients receiving early alemtuzumab followed by fludarabine, thiotepa, melphalan, and al...
What is the current status of trial NCT02867800?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2016-07. Estimated completion is 2023-12-30.
What conditions does trial NCT02867800 study?
This clinical trial studies the following conditions: Sickle Cell Disease, Graft-Versus-Host Disease.
What interventions are being tested in trial NCT02867800?
The interventions under investigation include: Acetaminophen (DRUG), Alemtuzumab (DRUG), Methylprednisolone (DRUG), Diphenhydramine (DRUG), Meperidine (DRUG).
Who is sponsoring clinical trial NCT02867800?
This trial is sponsored by Monica Bhatia, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02867800 being conducted?
This trial has 7 study locations across District of Columbia, Georgia, Illinois, Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02867800's enrollment target sits among peer trials
24 160th of 213 higher than 49 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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