drugset / Trial / NCT00210119

Imatinib Mesylate and Zoledronic Acid in Patients With Chronic Myeloid Leukaemia in Cytogenetic Response Without Molecular Response

NCT00210119 ↗

Phase 2 Terminated 19 enrolled Institut Bergonié Novartis · collab
NaSingle-groupOpen-labelTreatment

Summary

Imatinib mesylate is standard treatment of Chronic myeloid leukaemia, complete cytogenetic response is obtained in most of cases but molecular response concerned only a small part of the patients. To increase molecular response ratio we decided to increase imatinib dose to limited resistance to this drug and to add zoledronate for it anti tumoral activity to increase anti leukemic effect. We plan to accrue 37 patients in 5 centers. We will analyse molecular expression of BCR-ABL transcript after 6 months of treatment, safety, duration of response, VEGF expression and LTgd production.

Timeline

Start
2006-07-12
Primary completion
2007-09
Completion
2009-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Imatinib Small molecule 600 mg Oral
Subject Imatinib Small molecule 800 mg Oral