Recurrent Adult Acute Lymphoblastic Leukemia Clinical Trial
Official title:
A Phase 1/2 Study of SNDX-275 in Combination With Imatinib for Relapsed/Refractory Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
This phase I/II trial is studying the side effects and best dose of entinostat when given together with imatinib mesylate and to see how well it works in treating patients with relapsed or refractory Philadelphia chromosome-positive acute lymphoblastic leukemia. Entinostat and imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth
PRIMARY OBJECTIVES:
I. To determine the maximum tolerated dose (MTD) of entinostat when given in combination
with imatinib (matinib mesylate).
SECONDARY OBJECTIVES:
I. To estimate the rate of complete response (CR) for patients greater ≥ 18 years of age
with relapsed/refractory Ph+ ALL treated with a combination of entinostat and imatinib.
II. To estimate the 1 year progression free survival (PFS) for patients greater ≥ 18 years
of age with relapsed/refractory Ph+ ALL treated with a combination of entinostat and
imatinib III. To describe the comparative pharmacokinetics (PK) and pharmacodynamics (PD) of
entinostat when administered alone vs. in combination with imatinib.
IV. To assess the predictive value of levels of flow cytometric minimal residual disease
(MRD) on duration of progression free survival for the study population.
OUTLINE: This is a phase I, dose-escalation study of entinostat followed by a phase II
study.
Patients receive entinostat orally (PO) daily on days 1, 8, 15, and 22 and imatinib mesylate
PO twice daily on days 1-28 (days 4-28 of course 1). Courses repeat every 28 days in the
absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 30 days.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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