drugset / Trial / NCT00219765
Safety and Efficacy of Imatinib in Combination With High Dose Chemotherapy for Acute Phase Chronic Myelogenous Patients
Phase 1/2
Terminated
30 enrolled
Poitiers University Hospital
Ministry of Health, France · collabNovartis · collab
Non-randomizedSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2001-05
- Primary completion
- —
- Completion
- 2006-01
Publications
- Rousselot P, Cony-Makhoul P, Nicolini F, Mahon FX, Berthou C, Rea D, Reiffers J, Bornand A, Saint-Jean O, Guilhot J, Guilhot F; French Intergroup For Chronic Myelogenous Leukemia (Fi-LMC). Long-term safety and efficacy of imatinib mesylate (Gleevec(R)) in elderly patients with chronic phase chronic myelogenous leukemia: results of the AFR04 study. Am J Hematol. 2013 Jan;88(1):1-4. doi: 10.1002/ajh.23330. Epub 2012 Sep 17.
- Deau B, Nicolini FE, Guilhot J, Huguet F, Guerci A, Legros L, Pautas C, Berthou C, Guyotat D, Cony-Makhoul P, Gardembas M, Michallet M, Hayette S, Cayuela JM, Weiss IR, Rea D, Castaigne S, Mahon FX, Guilhot F, Rousselot P. The addition of daunorubicin to imatinib mesylate in combination with cytarabine improves the response rate and the survival of patients with myeloid blast crisis chronic myelogenous leukemia (AFR01 study). Leuk Res. 2011 Jun;35(6):777-82. doi: 10.1016/j.leukres.2010.11.004. Epub 2010 Dec 10.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Daunorubicin | Small molecule | 0 mg/m2 | — |
| Subject | Daunorubicin | Small molecule | 15 mg/m2 | — |
| Subject | Daunorubicin | Small molecule | 30 mg/m2 | — |
| Subject | Daunorubicin | Small molecule | 45 mg/m2 | — |
| Background | Cytarabine | Small molecule | 100 mg/m2 | Intravenous |
| Background | Imatinib | Small molecule | 600 mg | — |