NCT02906696

Bosutinib in Treating Patients With Chronic Myeloid Leukemia in Chronic Phase After Frontline TKI Failure

An Open-Label Phase II Dose Optimization Study of Bosutinib at a Starting Dose of 300 Mg Daily for Adult Patients With Chronic Myeloid Leukemia (CML) in Chronic Phase Post Frontline TKI Failure

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well bosutinib works in treating patients with chronic myeloid leukemia in chronic phase after frontline tyrosine kinase inhibitor (TKI) failure. Bosutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Detailed description

PRIMARY OBJECTIVES: I. To assess the response rate within 24 weeks in patients in chronic phase receiving bosutinib with the starting dose of 300 mg per day, with potential escalation to 400 mg, 500 mg and 600 mg per day. SECONDARY OBJECTIVES: I. Safety of dosing schedule. II. Frequency of treatment interruptions and dose reductions. III. Determine the rate of BCR-ABL/ABL \< 10% at 3 months and \< 1% at 6 months on the international scale and the rate of complete cytogenetic response (CCyR) at 6 months after the start of treatment. IV. Determine the cumulative rate of CCyR. V. Determine the rate of major molecular response, molecular response (MR)4, MR4.5 and complete molecular response. VI. Determine long-term outcomes, including progression-free survival, event-free survival, and overall survival. VIII. Investigate the correlation between ABL kinase domain mutations, if present at the time of enrollment, with outcome. IX. Determine the rate of development and type of ABL kinase domain mutations during therapy with bosutinib. OUTLINE: Patients receive bosutinib orally (PO) daily on days 1-28. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 12 weeks for up to 2 years, every 24 weeks for 2 years.

Conditions

• Blasts Under 15 Percent of Bone Marrow Nucleated Cells
• Blasts Under 15 Percent of Peripheral Blood White Cells
• Blasts Under 30 Percent of Bone Marrow Nucleated Cells
• Blasts Under 30 Percent of Peripheral Blood White Cells
• Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive

Interventions

Type	Name	Description
DRUG	Bosutinib	Given PO
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 2016-10-28
• Primary completion: 2019-08-08
• Completion: 2019-08-08
• First posted: 2016-09-20
• Last updated: 2020-05-11
• Results posted: 2020-04-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study