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NCT04503616 · ClinicalTrials.gov registry record · Phase 1
Cyclophosphamide, Abatacept, and Tacrolimus for GvHD Prevention
A Phase 1 study, sponsored by NYU Langone Health.
- Completed
- Registry status
- Phase 1
- Development phase
- 46
- Enrollment target
NCT04503616: Completed Phase 1 study, sponsored by NYU Langone Health.
NCT04503616 is a Phase 1 study that has completed, run by NYU Langone Health. The registered enrollment target is 46 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04503616, a Phase 1 study, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 46 participants
- Enrollment target
Study Summary
This is a single arm, open label, optimal 2-stage Simon design phase Ib-II clinical trial. Adult patients with hematological malignancies undergoing allogeneic HSCT from first- or second-degree haploidentical donor are eligible for the study if they meet the standard criteria defined in our institutional standard operation procedures (SOPs), meet all inclusion criteria, and do not satisfy any exclusion criteria. Patients will receive non-myeloablative, reduced-intensity or myeloablative conditioning regimen followed by peripheral blood hematopoietic stem cells. Patients will receive cyclophosphamide, abatacept, and short-duration tacrolimus for GvHD prophylaxis.
Primary Outcome
The first day of grade II-IV acute GvHD will be used to calculate the cumulative incidence. The cumulative incidence will be defined as the percentage of participants with grade II-IV acute GvHD. The diagnosis of acute GvHD is based on clinical and pathological evaluation by the principal investigator in collaboration with the treating physician. Overall Grades of Acute GvHD: 0 = none; 1. = mild; 2. = moderate; 3. = severe; 4. = life threatening
Interventions
- DRUG Cyclophosphamide, Abatacept, and Tacrolimus for GvHD Prevention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2020-09-16 |
| Est. Completion | 2024-08-15 |
| Phase | Phase 1 |
What the finished NCT04503616 record still lists
NCT04503616 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% lower).
The record links to 0 conditions, and to 1 intervention - of which Cyclophosphamide, Abatacept, and Tacrolimus for GvHD Prevention is the first listed.
NCT04503616 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04503616 about?
NCT04503616 is a clinical study titled "Cyclophosphamide, Abatacept, and Tacrolimus for GvHD Prevention". This is a single arm, open label, optimal 2-stage Simon design phase Ib-II clinical trial. Adult patients with hematological malignancies undergoing allogeneic HSCT from first- or second-degree haploidentical donor are eligible for the study if they meet the standard criteria defined in our institut...
What is the current status of trial NCT04503616?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 46 participants. The study started on 2020-09-16. Estimated completion is 2024-08-15.
What interventions are being tested in trial NCT04503616?
The interventions under investigation include: Cyclophosphamide, Abatacept, and Tacrolimus for GvHD Prevention (DRUG).
Who is sponsoring clinical trial NCT04503616?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04503616's enrollment target sits among peer trials
46 1058th of 2000 higher than 935 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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