drugset / Trial / NCT00763763
Imatinib Mesylate With Vincristine and Dexamethasone in Acute Lymphoblastic Leukemias With BCR-ABL Positive
Non-randomizedSingle-groupOpen-labelTreatment
Summary
Patients not previously exposed to imatinib and with resistant or refractory Ph+ ALL, lymphoid blast crisis chronic myelogenous leukaemia (LBC CML) or with de novo Ph+ ALL and aged over 55y were eligible in the study. The DIV regimen consisted in one IV injection of vincristine 2 mg combined with 2 days of dexamethasone 40 mg PO repeated weekly for 4 weeks as induction and then monthly for 4 months as consolidation. Imatinib was administered at 800 mg per day during the induction period and at 600 mg/d continuously during consolidation. Patients in CR not eligible for HSCT were allocated to maintenance therapy consisting in weekly SC injection of Pegasys 45 µg and continuous administration of imatinib 400 mg per day for 2 years.
Timeline
- Start
- 2004-12
- Primary completion
- 2007-10
- Completion
- 2010-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Imatinib | Small molecule | 600 mg | — |
| Background | Dexamethasone | Small molecule | 40 mg | Oral |
| Background | Vincristine | Small molecule | 2 mg | Intravenous |
| Background | interferon alfa-2b | Protein / enzyme biologic | 45 ug | Subcutaneous |