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NCT00038649 · ClinicalTrials.gov registry record · Phase 2
Therapy of Early Chronic Phase CML With Higher-Dose Gleevec, Alpha Interferon, and Low-Dose Ara-C
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 117
- Enrollment target
NCT00038649: Clinical Trial Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT00038649 is a Phase 2 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 117 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (12% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00038649, a Phase 2 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 117 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to see if higher doses of imatinib mesylate (Gleevec, STI571) can improve chronic myelogenous leukemia (CML) in chronic phase.
Primary Outcome
Complete Hematologic Remission (CHR): normalization \>4 weeks of bone marrow (\<5% blasts), peripheral blood with White Blood Cells (WBC) \<10 x 109/L \& no peripheral blasts, promyelocytes or myelocytes; disappearance all signs/symptoms disease. Partial Hematologic Response (PHR) = CHR except persistence of immature cells (myelocytes, metamyelocytes), or splenomegaly \< 50% of pretreatment, or thrombocytosis \>450x109/L but \<50% of pretreatment. Hematologic surveys twice per year with bone asp
Interventions
- DRUG Gleevec
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 117 participants |
| Start Date | 2001-06 |
| Est. Completion | 2013-11 |
| Phase | Phase 2 |
Why NCT00038649 stopped before completion
NCT00038649 is an interventional study that assigns participants to a tested intervention. The registered 117 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (12% lower).
The record links to 0 conditions, and to 1 intervention - of which Gleevec is the first listed.
NCT00038649 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00038649 about?
NCT00038649 is a clinical study titled "Therapy of Early Chronic Phase CML With Higher-Dose Gleevec, Alpha Interferon, and Low-Dose Ara-C". The goal of this clinical research study is to see if higher doses of imatinib mesylate (Gleevec, STI571) can improve chronic myelogenous leukemia (CML) in chronic phase.
What is the current status of trial NCT00038649?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 117 participants. The study started on 2001-06. Estimated completion is 2013-11.
What interventions are being tested in trial NCT00038649?
The interventions under investigation include: Gleevec (DRUG).
Who is sponsoring clinical trial NCT00038649?
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 NCT00038649's enrollment target sits among peer trials
117 623rd of 2000 higher than 1,378 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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