NCT01426334

Dasatinib and Cyclosporine in Treating Patients With Chronic Myelogenous Leukemia Refractory or Intolerant to Imatinib Mesylate

Exploiting Synergy in Chronic Myelogenous Leukemia: A Phase Ib Evaluation of Dasatinib Plus Cyclosporine in Patients With Ph+ Leukemia (ESCAPE1b)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial studies the side effects and the best way to give dasatinib and cyclosporine in treating patients with chronic myelogenous leukemia (CML) refractory or intolerant to imatinib mesylate. Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Cyclosporine may help dasatinib work better by making cancer cells more sensitive to the drug. Giving dasatinib together with cyclosporine may be an effective treatment for CML.

Detailed description

PRIMARY OBJECTIVES: I. To define the safety and tolerability of cyclosporine A in combination with dasatinib in adults with Bcr-Abl+ chronic myelogenous leukemia in chronic phase, or when used in specified patients with accelerated phase CML. SECONDARY OBJECTIVES: I. To assess pharmacokinetic parameters of dasatinib when combined with cyclosporine. II. To assess whether the combination of dasatinib and cyclosporine alters T cell number and function. III. To assess the feasibility of determining phosphorylation of Src in peripheral blood mononuclear cells by flow cytometry as a surrogate measure of dasatinib activity. OUTLINE: Patients receive dasatinib orally (PO) once daily (QD) on days 1-28 and cyclosporine PO twice daily (BID) on days 8-28. Treatment repeats every 28 days for 4 months in the absence of disease progression or unacceptable toxicity. Patients undergo peripheral blood sample collection at baseline and periodically during treatment for pharmacokinetic and pharmacodynamic studies and T-cell number and function by flow cytometry. After completion of study treatment, patients are followed up for 4 weeks.

Conditions

• Accelerated Phase Chronic Myelogenous Leukemia
• Chronic Myelogenous Leukemia, BCR-ABL1 Positive
• Chronic Phase Chronic Myelogenous Leukemia
• Relapsing Chronic Myelogenous Leukemia

Interventions

Type	Name	Description
DRUG	dasatinib	Given PO
OTHER	diagnostic laboratory biomarker analysis	Correlative studies
OTHER	pharmacological study	Correlative studies
DRUG	cyclosporine	Given PO

Timeline

• Start date: 2011-09-01
• Primary completion: 2012-06-01
• First posted: 2011-08-31
• Last updated: 2014-04-02

Locations

2 sites across 1 country: United States