Trials / Terminated
TerminatedNCT00219765
Safety and Efficacy of Imatinib in Combination With High Dose Chemotherapy for Acute Phase Chronic Myelogenous Patients
Phase I/II Trial to Study the Dose, Tolerability and the Effectiveness of Imatinib in Combination With Daunorubicine and Cytarabine for Patients With Chronic Myelogenous Leukemia in Myeloid Acute Phase
- Status
- Terminated
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 30 (planned)
- Sponsor
- Poitiers University Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The aim of this phase I/II trial is to determine the dose of daunorubicine to be associated with cytarabine and Imatinib for induction therapy in patients with chronic myelogenous leukemia in myeloid acute phase.
Detailed description
Study design Imatinib: starting at day -3: 600mg/day; continuous administration In combination with cytarabine: continuous iv/24h: 100mg/m² ; 7 days and daunorubicine: 4 levels level 1: 0 level 2: 15mg/m² ; 3 days level 3: 30mg/m² ; 3 days level 4: 45mg/m² ; 3 days
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Imatinib mesylate 600 mg | |
| DRUG | Cytarabine | |
| DRUG | Daunorubicine |
Timeline
- Start date
- 2001-05-01
- Completion
- 2006-01-01
- First posted
- 2005-09-22
- Last updated
- 2005-11-28
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT00219765. Inclusion in this directory is not an endorsement.