NCT01383447

Entinostat And Imatinib Mesylate In Treating Patients With Relapsed or Refractory Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia

A Phase 1/2 Study of SNDX-275 in Combination With Imatinib for Relapsed/Refractory Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Philadelphia Chromosome Positive Adult Precursor Acute Lymphoblastic Leukemia
• Recurrent Adult Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
DRUG	entinostat	Given PO
DRUG	imatinib mesylate	Given PO
OTHER	laboratory biomarker analysis	Correlative studies
OTHER	pharmacological study	Correlative studies
GENETIC	western blotting	Correlative studies
OTHER	immunohistochemistry staining method	Correlative studies
OTHER	flow cytometry	Correlative studies
GENETIC	polymerase chain reaction	Correlative studies
OTHER	high performance liquid chromatography	Correlative studies
OTHER	mass spectrometry	Correlative studies

Timeline

• Start date: 2010-10-01
• Primary completion: 2012-04-01
• Completion: 2012-04-01
• First posted: 2011-06-28
• Last updated: 2017-08-08
• Results posted: 2017-08-08

Locations

1 site across 1 country: United States