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NCT01410344 · ClinicalTrials.gov registry record · Phase 2
Allogeneic Transplant in HIV Patients (BMT CTN 0903)
A Phase 2 study, sponsored by Medical College of Wisconsin.
- Completed
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
NCT01410344: Completed Phase 2 study, sponsored by Medical College of Wisconsin.
NCT01410344 is a Phase 2 study that has completed, run by Medical College of Wisconsin. The registered enrollment target is 20 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01410344, a Phase 2 study, has completed, sponsored by Medical College of Wisconsin.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
Study Summary
The rationale for this trial is to demonstrate the feasibility and safety of allogeneic HCT for patients with chemotherapy-sensitive hematological malignancies and coincident HIV-infection. In particular, the trial will focus on the 100-day non-relapse mortality as an indicator of the safety of transplant in this patient population. Correlative assays will focus upon the incidence of infectious complications in this patient population, the evolution of HIV infection and immunological reconstitution. Where feasible (and when this can be accomplished without compromise of either the donor quality or the timeliness of transplantation), an attempt will be made to identify donors who are homozygotes for the delta32 mutation for CCR5.
Primary Outcome
The events for non-relapse mortality are death due to any cause other than relapse of the underlying malignancy.
Interventions
- DRUG Fludarabine and Busulfan
- DRUG Fludarabine and Melphalan
- DRUG Busulfan and Fludarabine
- DRUG Cyclophosphamide and Total Body Irradiation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2011-09 |
| Est. Completion | 2018-06 |
| Phase | Phase 2 |
What the finished NCT01410344 record still lists
NCT01410344 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 4 interventions - of which Fludarabine and Busulfan is the first listed.
NCT01410344 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01410344 about?
NCT01410344 is a clinical study titled "Allogeneic Transplant in HIV Patients (BMT CTN 0903)". The rationale for this trial is to demonstrate the feasibility and safety of allogeneic HCT for patients with chemotherapy-sensitive hematological malignancies and coincident HIV-infection. In particular, the trial will focus on the 100-day non-relapse mortality as an indicator of the safety of tran...
What is the current status of trial NCT01410344?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2011-09. Estimated completion is 2018-06.
What interventions are being tested in trial NCT01410344?
The interventions under investigation include: Fludarabine and Busulfan (DRUG), Fludarabine and Melphalan (DRUG), Busulfan and Fludarabine (DRUG), Cyclophosphamide and Total Body Irradiation (DRUG).
Who is sponsoring clinical trial NCT01410344?
This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01410344's enrollment target sits among peer trials
20 1805th of 2000 higher than 107 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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