A Phase 1/2 Study of SNDX-275 in Combination With Imatinib for Relapsed/Refractory Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
I. To determine the maximum tolerated dose (MTD) of entinostat when given in combination
with imatinib (matinib mesylate).
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
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
Maximum tolerated dose (MTD) of entinostat when given in combination with imatinib mesylate
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
Up to 30 days post-treatment
Johns Hopkins University
United States: Food and Drug Administration
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