Relapsing Chronic Myelogenous Leukemia Clinical Trial
Official title:
Exploiting Synergy in Chronic Myelogenous Leukemia: A Phase Ib Evaluation of Dasatinib Plus Cyclosporine in Patients With Ph+ Leukemia (ESCAPE1b)
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.
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.
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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