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NCT00201240 · ClinicalTrials.gov registry record · Phase 2
Acute Myeloid Leukemia T Cell Depletion to Improve Transplants in Adults With Acute Myeloid Leukemia (BMT CTN 0303)
A Phase 2 study of Leukemia, Myelocytic, Acute, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- Phase 2
- Development phase
- 47
- Enrollment target
- 8
- Study locations
NCT00201240: Completed Phase 2 study of Leukemia, Myelocytic, Acute, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
NCT00201240 is a Phase 2 study of Leukemia, Myelocytic, Acute that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 47 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower). The trial reports 8 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00201240, a Phase 2 study of Leukemia, Myelocytic, Acute, has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 47 participants
- Enrollment target
- 8
- Study locations
Study Summary
This study is a single arm Phase II, multicenter trial. It is designed to determine whether the anticipated endpoints for a T cell depleted transplant arm of a planned prospective randomized trial comparing T cell depleted and unmodified hematopoietic allografts are likely to be achieved in a multicenter study conducted by the Blood and Marrow Transplant Clinical Trials Network (BMT CTN or Network). The study population is patients with acute myeloid leukemia (AML) in first or second morphologic complete remission. The enrollment is 45 patients. Based on published results of unmodified transplants from HLA-matched siblings applied to patients with AML in first or second morphologic complete remission, a significant improvement in results with a graft modified as specified in this protocol would be expected if disease-free survival (DFS) at 6 months was greater than 75%, the true incidence of transplant-related mortality at 1 year was less than 30%, and the DFS rate at 2 years was greater 70% for patients transplanted in first remission and less than 60% for patients transplanted in second remission. Additional secondary endpoints include the following: graft failure rate and incidences of acute grade II-IV and chronic graft-versus-host disease (GVHD). Additionally, the trial will have target specific doses of CD34+ progenitors and CD3+ T cells to be obtained following fractionation with the CliniMACS system. Based on the results of this trial, a Phase III trial comparing T cell depleted peripheral blood stem cell transplants (PBSCT) with unmanipulated bone marrow or unmanipulated PBSCT will be designed.
Primary Outcome
The primary analysis will consist of estimating the 6-month DFS (from day of enrollment) probability based on the Kaplan-Meier product limit estimator. The 6-month DFS probability and confidence interval will be calculated. All registered patients will be considered for this analysis.
Conditions Studied
Interventions
- BIOLOGICAL CD34+ selection with CliniMACS device
Study Locations (8)
California
- City of Hope National Medical Center - Duarte
- University of California, San Francisco - San Francisco
Ohio
- University Hospitals of Cleveland/Case Western - Cleveland
- Ohio State/Arthur G. James Cancer Hospital - Columbus
Massachusetts
- Dana Farber Cancer Institute/Brigham & Women's Hospital - Boston
New York
- Memorial Sloan-Kettering Cancer Center - New York
Pennsylvania
- University of Pennsylvania Cancer Center - Philadelphia
Wisconsin
- Medical College of Wisconsin - Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2005-06 |
| Est. Completion | 2013-12 |
| Phase | Phase 2 |
What the finished NCT00201240 record still lists
NCT00201240 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 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower).
The record links to 1 condition, with Leukemia, Myelocytic, Acute appearing as the primary indexed condition, and to 1 intervention - of which CD34+ selection with CliniMACS device is the first listed.
NCT00201240 lists 8 locations in 6 states (California, Ohio, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT00201240 about?
NCT00201240 is a clinical study titled "Acute Myeloid Leukemia T Cell Depletion to Improve Transplants in Adults With Acute Myeloid Leukemia (BMT CTN 0303)". This study is a single arm Phase II, multicenter trial. It is designed to determine whether the anticipated endpoints for a T cell depleted transplant arm of a planned prospective randomized trial comparing T cell depleted and unmodified hematopoietic allografts are likely to be achieved in a multic...
What is the current status of trial NCT00201240?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 47 participants. The study started on 2005-06. Estimated completion is 2013-12.
What conditions does trial NCT00201240 study?
This clinical trial studies the following conditions: Leukemia, Myelocytic, Acute.
What interventions are being tested in trial NCT00201240?
The interventions under investigation include: CD34+ selection with CliniMACS device (BIOLOGICAL).
Who is sponsoring clinical trial NCT00201240?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00201240 being conducted?
This trial has 8 study locations across California, Massachusetts, New York, Ohio, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00201240's enrollment target sits among peer trials
47 1283rd of 2000 higher than 715 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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