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NCT00038831 · ClinicalTrials.gov registry record · Phase 1
Allo Transplantation With Mylotarg, Fludarabine and Melphalan for AML, CML and MDS
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 47
- Enrollment target
NCT00038831: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT00038831 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 47 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00038831, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 47 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to find the highest safe dose of Mylotarg that can be combined with chemotherapy in patients receiving allogeneic bone marrow transplantation. Researchers will study the effects of this treatment combination on patients with high-risk acute leukemia, chronic myelogenous leukemia, or myelodysplastic syndrome. Primary Objective: 1\. To determine the safety and maximum tolerated dose of Mylotarg as part of a reduced-intensity preparative regimen patients undergoing related, mismatched-related or matched unrelated donor transplantation. Secondary Objectives: 1. To evaluate response rates, engraftment kinetics and degree of chimerism achievable with this strategy. 2. To evaluate the incidence and severity of GVHD in this population 3. To evaluate disease-free and overall survival and relapse rates.
Interventions
- DRUG Fludarabine
- DRUG Melphalan
- DRUG Anti-thymocyte globulin
- PROCEDURE Stem cell transplant
- DRUG Mylotarg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2001-05 |
| Est. Completion | 2006-10 |
| Phase | Phase 1 |
What the finished NCT00038831 record still lists
NCT00038831 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% lower).
The record links to 0 conditions, and to 5 interventions - of which Fludarabine is the first listed.
NCT00038831 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00038831 about?
NCT00038831 is a clinical study titled "Allo Transplantation With Mylotarg, Fludarabine and Melphalan for AML, CML and MDS". The goal of this clinical research study is to find the highest safe dose of Mylotarg that can be combined with chemotherapy in patients receiving allogeneic bone marrow transplantation. Researchers will study the effects of this treatment combination on patients with high-risk acute leukemia, chron...
What is the current status of trial NCT00038831?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 47 participants. The study started on 2001-05. Estimated completion is 2006-10.
What interventions are being tested in trial NCT00038831?
The interventions under investigation include: Fludarabine (DRUG), Melphalan (DRUG), Anti-thymocyte globulin (DRUG), Stem cell transplant (PROCEDURE), Mylotarg (DRUG).
Who is sponsoring clinical trial NCT00038831?
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 NCT00038831's enrollment target sits among peer trials
47 1053rd of 2000 higher than 943 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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