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NCT01003054 · ClinicalTrials.gov registry record · Phase 2
Autologous Transplantation for Chronic Myelogenous Leukemia
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
NCT01003054: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT01003054 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 24 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01003054, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
Study Summary
The goal of this clinical research is to learn if treatment with high-dose busulfan and cyclophosphamide plus autologous bone marrow transplantation followed by treatment with Gleevec (imatinib mesylate) is effective in treating chronic myelogenous leukemia (CML). Objectives: 1. To assess the efficacy of high dose busulfan-cyclophosphamide and autologous hematopoietic transplantation with post transplant Imatinib mesylate for the treatment of CML. The primary endpoint of the study is to determine the proportion of patients with CML alive in cytogenetic remission at one year following this treatment. 2. Secondary endpoints are time to progression and survival.
Primary Outcome
Cytogenetic complete remission confirmed via bone marrow examination for morphology, cytogenetics or Fluorescence in situ hybridization (FISH).
Interventions
- DRUG Cyclophosphamide
- DRUG Busulfan
- DRUG Imatinib Mesylate
- PROCEDURE Autologous Stem Cell Transplantation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2005-03 |
| Est. Completion | 2009-10 |
| Phase | Phase 2 |
What the finished NCT01003054 record still lists
NCT01003054 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT01003054 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01003054 about?
NCT01003054 is a clinical study titled "Autologous Transplantation for Chronic Myelogenous Leukemia". The goal of this clinical research is to learn if treatment with high-dose busulfan and cyclophosphamide plus autologous bone marrow transplantation followed by treatment with Gleevec (imatinib mesylate) is effective in treating chronic myelogenous leukemia (CML). Objectives: 1. To assess the effi...
What is the current status of trial NCT01003054?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2005-03. Estimated completion is 2009-10.
What interventions are being tested in trial NCT01003054?
The interventions under investigation include: Cyclophosphamide (DRUG), Busulfan (DRUG), Imatinib Mesylate (DRUG), Autologous Stem Cell Transplantation (PROCEDURE).
Who is sponsoring clinical trial NCT01003054?
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 NCT01003054's enrollment target sits among peer trials
24 1756th of 2000 higher than 217 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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