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NCT00050531 · ClinicalTrials.gov registry record · Phase 3
High-Dose Gleevec Alone or in Combination With Peg-Intron and GM-CSF in Early Phase Chronic Myelogenous Leukemia (CML)
A Phase 3 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 94
- Enrollment target
NCT00050531: Completed Phase 3 study, sponsored by M.D. Anderson Cancer Center.
NCT00050531 is a Phase 3 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 94 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00050531, a Phase 3 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 94 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to learn if giving PEG-Alpha Interferon (PEG-Intron) and Sargramostim (GM-CSF) to patients receiving treatment with high dose Gleevec (imatinib mesylate) is more effective in treating CML in chronic phase than therapy with imatinib mesylate alone.
Primary Outcome
Duration measured in time from first response to disease progression; Cytogenetic (or FISH), and PCR quantification every 3-4 months as indicated in year one then FISH every 1-3 years and PCR every year
Interventions
- DRUG Gleevec
- DRUG Peg-alpha interferon (Peg-Intron)
- DRUG Sargramostim (GM-CSF)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 94 participants |
| Start Date | 2003-04 |
| Est. Completion | 2015-08 |
| Phase | Phase 3 |
What the finished NCT00050531 record still lists
NCT00050531 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 94 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 3 interventions - of which Gleevec is the first listed.
NCT00050531 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00050531 about?
NCT00050531 is a clinical study titled "High-Dose Gleevec Alone or in Combination With Peg-Intron and GM-CSF in Early Phase Chronic Myelogenous Leukemia (CML)". The goal of this clinical research study is to learn if giving PEG-Alpha Interferon (PEG-Intron) and Sargramostim (GM-CSF) to patients receiving treatment with high dose Gleevec (imatinib mesylate) is more effective in treating CML in chronic phase than therapy with imatinib mesylate alone.
What is the current status of trial NCT00050531?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 94 participants. The study started on 2003-04. Estimated completion is 2015-08.
What interventions are being tested in trial NCT00050531?
The interventions under investigation include: Gleevec (DRUG), Peg-alpha interferon (Peg-Intron) (DRUG), Sargramostim (GM-CSF) (DRUG).
Who is sponsoring clinical trial NCT00050531?
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 NCT00050531's enrollment target sits among peer trials
94 1719th of 2000 higher than 279 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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