BMS-354825 or Imatinib Mesylate in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia That Did Not Respond to Previous Imatinib Mesylate

Leukemia Clinical Trial

Official title: A Randomized Multi-Center Open Label Study of BMS-354825 vs Imatinib Mesylate (Gleevec®) 800 mg/d in Subjects With Chronic Phase Philadelphia Chromosome-Positive Chronic Myeloid Leukemia Who Have Disease That is Resistant to Iamtinib at a Dose of 400-600 mg/d

Status Active, not recruiting

Clinical Trial Summary

RATIONALE: BMS-354825 and imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This randomized phase II trial is studying BMS-354825 to see how well it works compared to imatinib mesylate in treating patients with chronic phase chronic myelogenous leukemia that did not respond to previous imatinib mesylate.

Clinical Trial Description

OBJECTIVES:

Primary

• Determine the 12-week major cytogenetic response (MCyR) rate in patients with imatinib mesylate-resistant Philadelphia chromosome-positive chronic phase chronic myelogenous leukemia treated with BMS-354825 vs imatinib mesylate.

Secondary

• Determine the MCyR rate prior to crossover in patients treated with these drugs.

• Determine the durability of MCyR and time to MCyR prior to crossover in patients treated with these drugs.

• Determine the complete hematologic response (CHR) rate prior to crossover in patients treated with these drugs.

• Determine the durability of CHR and time to CHR prior to crossover in patients treated with these drugs.

• Determine the major molecular response rate prior to crossover, as determined by BCR-ABL transcripts in blood during treatment using quantitative reverse transcriptase polymerase chain reaction, in patients treated with these drugs.

• Determine post-crossover efficacy endpoints in patients treated with these drugs who crossover.

• Assess health-related quality of life prior to crossover in patients treated with these drugs.

• Determine the safety and tolerability of BMS-354825 in these patients.

• Determine the pharmacokinetics of BMS-354825 in these patients.

OUTLINE: This is an open-label, multicenter, randomized, crossover study. Patients are stratified according to study site and cytogenetic response to prior imatinib mesylate (yes vs no). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive oral BMS-354825 twice daily in the absence of disease progression or unacceptable toxicity. Patients experiencing disease progression or persistent intolerance to BMS-354825 cross over to arm II after a 2-day washout period. After crossover, patients receive oral imatinib mesylate twice daily in the absence of further disease progression or unacceptable toxicity.

• Arm II: Patients receive oral imatinib mesylate twice daily in the absence of disease progression or unacceptable toxicity. Patients experiencing disease progression, intolerance to imatinib mesylate, lack of major cytogenetic response at 12 weeks, or < 30% absolute reduction in Philadelphia chromosome-positive metaphases at 12 weeks cross over to arm I after a 1-week washout period. After crossover, patients receive oral BMS-354825 twice daily in the absence of further disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, at day 29, every 4 weeks for 24 weeks, every 12 weeks for the remainder of study treatment, and then at the completion of study treatment.

After the completion of study treatment, patients are followed for at least 30 days.

PROJECTED ACCRUAL: A minimum of 150 patients (100 in arm I and 50 in arm II) will be accrued for this study within 6-12 months. ;

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Leukemia, Myeloid, Chronic-Phase

• NCT number: NCT00112775
• Study type: Interventional
• Source: National Cancer Institute (NCI)
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: March 2005