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NCT01323920 · ClinicalTrials.gov registry record · Phase 2
Bortezomib-based GVHD Prophylaxis After Allogeneic Transplant for Patients Without Matched Related Donors
A Phase 2 study, sponsored by Dana-Farber Cancer Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 35
- Enrollment target
NCT01323920: Completed Phase 2 study, sponsored by Dana-Farber Cancer Institute.
NCT01323920 is a Phase 2 study that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 35 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01323920, a Phase 2 study, has completed, sponsored by Dana-Farber Cancer Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 35 participants
- Enrollment target
Study Summary
A common problem after stem cell transplant is graft-versus-host-disease (GVHD). GVHD is a complication of transplantation where the donor graft attacks and damages some of your tissues. After stem cell transplant, all patients receive prophylactic medications against GVHD. In this research study, we are studying the safety and effectiveness of a bortezomib based GVHD prophylaxic drug combination in participants after myeloablative allogeneic stem call transplantation from a matched unrelated donor, mismatched related or unrelated donor.
Primary Outcome
The primary outcome of this study is the cumulative incidence of grade II-IV acute GVHD up to Day 100 after stem cell infusion. Acute GHVD is graded according to the modified Glucksberg criteria (adapted from Thomas et al., NEJM ,1975, pp. 895-90), which is based on criteria by which the provider classifies acute GVHD per its objective organ staging. Acute GVHD is assessed in weekly standard of care visits post stem cell infusion and is captured in the protocol EDC upon evaluation of clinical no
Interventions
- DRUG Tacrolimus
- DRUG Bortezomib
- DRUG Methotrexate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2011-05 |
| Est. Completion | 2013-11 |
| Phase | Phase 2 |
What the finished NCT01323920 record still lists
NCT01323920 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 3 interventions - of which Tacrolimus is the first listed.
NCT01323920 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01323920 about?
NCT01323920 is a clinical study titled "Bortezomib-based GVHD Prophylaxis After Allogeneic Transplant for Patients Without Matched Related Donors". A common problem after stem cell transplant is graft-versus-host-disease (GVHD). GVHD is a complication of transplantation where the donor graft attacks and damages some of your tissues. After stem cell transplant, all patients receive prophylactic medications against GVHD. In this research study, ...
What is the current status of trial NCT01323920?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 35 participants. The study started on 2011-05. Estimated completion is 2013-11.
What interventions are being tested in trial NCT01323920?
The interventions under investigation include: Tacrolimus (DRUG), Bortezomib (DRUG), Methotrexate (DRUG).
Who is sponsoring clinical trial NCT01323920?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01323920's enrollment target sits among peer trials
35 1524th of 2000 higher than 462 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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