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NCT00506922 · ClinicalTrials.gov registry record · Phase 1
Phase I/II Study of Pentostatin Combined With Tacrolimus and Mini-Methotrexate for GVHD Prevention After MUD BMT
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 150
- Enrollment target
NCT00506922: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT00506922 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 150 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (150% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00506922, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 150 participants
- Enrollment target
Study Summary
Primary Objective: 1\. To determine efficacy of escalating doses of pentostatin in combination with tacrolimus and methotrexate for the prevention of acute graft-versus-host disease (GVHD) in the context of unrelated donor and one antigen mismatched related donor transplantation. Secondary Objectives: 1. To determine safety of escalating doses of pentostatin in combination with tacrolimus and methotrexate. 2. To reduce the incidence of acute GVHD following transplants with unrelated donor to 40%. 3. To document blood levels of tacrolimus when combined with pentostatin.
Primary Outcome
The primary efficacy endpoint of escalating doses Pentostatin with Tacrolimus + Methotrexate is success, defined to be that the patient is alive, engrafted, and without acute graft-versus-host disease (GVHD) at 100 days.
Interventions
- DRUG Tacrolimus
- DRUG Methotrexate
- DRUG Pentostatin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2000-09 |
| Est. Completion | 2009-11 |
| Phase | Phase 1 |
What the finished NCT00506922 record still lists
NCT00506922 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (150% higher).
The record links to 0 conditions, and to 3 interventions - of which Tacrolimus is the first listed.
NCT00506922 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00506922 about?
NCT00506922 is a clinical study titled "Phase I/II Study of Pentostatin Combined With Tacrolimus and Mini-Methotrexate for GVHD Prevention After MUD BMT". Primary Objective: 1\. To determine efficacy of escalating doses of pentostatin in combination with tacrolimus and methotrexate for the prevention of acute graft-versus-host disease (GVHD) in the context of unrelated donor and one antigen mismatched related donor transplantation. Secondary Objecti...
What is the current status of trial NCT00506922?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 150 participants. The study started on 2000-09. Estimated completion is 2009-11.
What interventions are being tested in trial NCT00506922?
The interventions under investigation include: Tacrolimus (DRUG), Methotrexate (DRUG), Pentostatin (DRUG).
Who is sponsoring clinical trial NCT00506922?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00506922's enrollment target sits among peer trials
150 363rd of 2000 higher than 1,620 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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