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NCT01092741 · ClinicalTrials.gov registry record · Phase 2
Late Chronic Phase Chronic Myelogenous Leukemia
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 47
- Enrollment target
NCT01092741: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT01092741 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. 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). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01092741, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 47 participants
- Enrollment target
Study Summary
Objectives: Primary endpoints: To achieve low levels of Polymerase Chain Reaction (PCR) ratios of B-cell antigen receptor (Bcr-Abl)/Bcr (molecular CR) in a significant proportion of patients after 12 months of higher doses (800 mg daily) of Gleevec therapy To increase the proportion of patients achieving a complete cytogenetic response in patients with Ph-positive chronic phase CML using initial higher dose Gleevec therapy. Secondary endpoints: To evaluate the durations of PCR negativity, cytogenetic response, hematologic control, and survival. To analyze differences in response rates and in prognosis within different risk groups and patient characteristics
Primary Outcome
CR Rate = Number participants out of total treated with complete cytogenetic response. Complete Hematologic Remission (CHR) - normalization \>4 weeks of bone marrow (less than 5% blasts) \& peripheral blood with white blood count (WBC)\<10x10\^9/L \& no peripheral blasts, promyelocytes or myelocytes, disappearance of all signs \& symptoms of disease. Partial Hematologic Response (PHR) = CHR except persistence of immature cells (myelocytes, metamyelocytes), or splenomegaly \<50% of pretreatment,
Interventions
- DRUG Gleevec
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2001-07 |
| Est. Completion | 2013-09 |
| Phase | Phase 2 |
What the finished NCT01092741 record still lists
NCT01092741 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 0 conditions, and to 1 intervention - of which Gleevec is the first listed.
NCT01092741 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01092741 about?
NCT01092741 is a clinical study titled "Late Chronic Phase Chronic Myelogenous Leukemia". Objectives: Primary endpoints: To achieve low levels of Polymerase Chain Reaction (PCR) ratios of B-cell antigen receptor (Bcr-Abl)/Bcr (molecular CR) in a significant proportion of patients after 12 months of higher doses (800 mg daily) of Gleevec therapy To increase the proportion of patients ac...
What is the current status of trial NCT01092741?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 47 participants. The study started on 2001-07. Estimated completion is 2013-09.
What interventions are being tested in trial NCT01092741?
The interventions under investigation include: Gleevec (DRUG).
Who is sponsoring clinical trial NCT01092741?
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 NCT01092741'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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