drugset / Trial / NCT00763763

Imatinib Mesylate With Vincristine and Dexamethasone in Acute Lymphoblastic Leukemias With BCR-ABL Positive

NCT00763763

Phase 2 Completed 55 enrolled Assistance Publique - Hôpitaux de Paris
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

EvaluationDrugModalityDoseRoute
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