drugset / Trial / NCT00171249

An Extension Study to Determine the Safety and Anti-Leukemic Effects of Imatinib Mesylate in Adult Participants With Ph+ Leukemia

NCT00171249 ↗

Phase 2 Completed 293 enrolled Novartis Pharmaceuticals
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The objectives of Part 1 of the study were: * To determine the rate of hematologic response (HR) lasting ≥4 weeks in participants with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in the accelerated phase (AP). * To evaluate duration of HR, overall survival, cytogenetic response (CyR), time to blast crisis in CML participants in the AP, improvement of symptomatic parameters, tolerability and safety of STI571 treatment. The objective of the extension (Part 2) was: -To enable participants to have access to study drug and continue study treatment and to decrease data collection to include only overall survival and serious adverse events.

Timeline

Start
1999-08-09
Primary completion
2013-09-23
Completion
2013-09-23

Drugs

EvaluationDrugModalityDoseRoute
Subject Imatinib Small molecule 400 mg Oral
Subject Imatinib Small molecule 600 mg Oral