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NCT02996773 · ClinicalTrials.gov registry record · Phase 1
Haploidentical BMT With Post-Transplant Cyclophosphamide and Bendamustine
A Phase 1 study, sponsored by University of Arizona.
- Completed
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
NCT02996773: Completed Phase 1 study, sponsored by University of Arizona.
NCT02996773 is a Phase 1 study that has completed, run by University of Arizona. The registered enrollment target is 50 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02996773, a Phase 1 study, has completed, sponsored by University of Arizona.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety of progressively substituting day +3 and +4 post-transplant cyclophosphamide (PT-CY) with post-transplant bendamustine (PT-BEN) in myeloablative (MAC) haploidentical hematopoietic cell transplantation (HHCT) for patients with hematological malignancies. The goal of the Phase 1 component of the study is to evaluate the safety of progressively substituting post-transplant cyclophosphamide (PT-CY) given on Days +3 and +4 with bendamustine (PT-BEN). The Phase I component of the study has been completed. The Phase Ib component of the study will continue to evaluate the safety and efficacy of subjects who receive PT-BEN on Days +3 and +4 at the maximum tolerated dose determined by Phase I. The Phase Ib component of the study has been completed. Approximately, 18-36 subjects will be treated as part of Phase I and 15 as part of Phase Ib. Approximately 18 subjects will be used as controls, subjects that receive no PET-BEN, for direct comparison. Total, approximately 38-56 treatment and control patients and 38-56 donor subjects will be enrolled.
Primary Outcome
Examine the effects of PT-BEN on immune reconstitution following human haploidentical BMT.
Interventions
- DRUG Cyclophosphamide
- DRUG Bendamustine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2016-11-29 |
| Est. Completion | 2025-08-01 |
| Phase | Phase 1 |
What the finished NCT02996773 record still lists
NCT02996773 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower).
The record links to 0 conditions, and to 2 interventions - of which Cyclophosphamide is the first listed.
NCT02996773 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02996773 about?
NCT02996773 is a clinical study titled "Haploidentical BMT With Post-Transplant Cyclophosphamide and Bendamustine". The purpose of this study is to evaluate the safety of progressively substituting day +3 and +4 post-transplant cyclophosphamide (PT-CY) with post-transplant bendamustine (PT-BEN) in myeloablative (MAC) haploidentical hematopoietic cell transplantation (HHCT) for patients with hematological malignan...
What is the current status of trial NCT02996773?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2016-11-29. Estimated completion is 2025-08-01.
What interventions are being tested in trial NCT02996773?
The interventions under investigation include: Cyclophosphamide (DRUG), Bendamustine (DRUG).
Who is sponsoring clinical trial NCT02996773?
This trial is sponsored by University of Arizona, which has 349 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02996773's enrollment target sits among peer trials
50 973rd of 2000 higher than 984 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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