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NCT00038610 · ClinicalTrials.gov registry record · Phase 2
Study of Hyper-CVAD Plus Imatinib Mesylate for Philadelphia-Positive Acute Lymphocytic Leukemia
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 54
- Enrollment target
NCT00038610: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT00038610 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 54 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00038610, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 54 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to learn if intensive chemotherapy, combined with imatinib mesylate (Gleevec, STI571) given for 8 courses over 6 months, followed by maintenance imatinib mesylate plus chemotherapy for 2 years, followed by imatinib mesylate indefinitely can improve Philadelphia-positive acute lymphoblastic leukemia. The safety of this treatment will also be studied.
Primary Outcome
Complete Remission (CR): Defined as the presence of 5% or less blasts in the bone marrow, with a granulocyte count of 1.0 × 109/L or higher and a platelet count of 100 × 109/L and no extramedullary disease. Partial Response (PR): As above for CR except for the presence of 6-25% marrow blasts. Molecular CR: Same as for CR with RT-PCR negativity for bcr-abl. Induction Death: Defined as death occurring after start of therapy without meeting the definition of CR or resistant disease.
Interventions
- DRUG Cyclophosphamide
- DRUG Doxorubicin
- DRUG Dexamethasone
- DRUG Vincristine
- DRUG Imatinib Mesylate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2001-03 |
| Est. Completion | 2014-07 |
| Phase | Phase 2 |
What the finished NCT00038610 record still lists
NCT00038610 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% lower).
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT00038610 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00038610 about?
NCT00038610 is a clinical study titled "Study of Hyper-CVAD Plus Imatinib Mesylate for Philadelphia-Positive Acute Lymphocytic Leukemia". The goal of this clinical research study is to learn if intensive chemotherapy, combined with imatinib mesylate (Gleevec, STI571) given for 8 courses over 6 months, followed by maintenance imatinib mesylate plus chemotherapy for 2 years, followed by imatinib mesylate indefinitely can improve Philade...
What is the current status of trial NCT00038610?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 54 participants. The study started on 2001-03. Estimated completion is 2014-07.
What interventions are being tested in trial NCT00038610?
The interventions under investigation include: Cyclophosphamide (DRUG), Doxorubicin (DRUG), Dexamethasone (DRUG), Vincristine (DRUG), Imatinib Mesylate (DRUG).
Who is sponsoring clinical trial NCT00038610?
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 NCT00038610's enrollment target sits among peer trials
54 1160th of 2000 higher than 830 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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