Study to Evaluate Efficacy, Safety, Tolerability, and Pharmacodynamics of Entospletinib in Adults With Relapsed or Refractory Hematologic Malignancies
NCT01799889 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 326
Last updated 2020-11-19
Summary
The primary objective of the study is to evaluate efficacy of entospletinib in participants with relapsed or refractory hematologic malignancies. Participants with the following relapsed or refractory hematologic malignancies will be enrolled into the study: relapsed or refractory chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), or non-FL indolent non-Hodgkin lymphomas (iNHL; including lymphoplasmacytoid lymphoma/ Waldenström macroglobulinemia \[LPL/WM\], small lymphocytic lymphoma \[SLL\], or marginal zone lymphoma \[MZL\]).
Conditions
- Chronic Lymphocytic Leukemia
- Mantle Cell Lymphoma
- Diffuse Large B-cell Lymphoma
- Non-FL Indolent Non-Hodgkin's Lymphoma
- Follicular Lymphoma
Interventions
- DRUG
-
Entospletinib MM
Entospletinib MM tablet administered orally
- DRUG
-
Entospletinib SDD
Entospletinib SDD tablet administered orally
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Gilead Study Director · Gilead Sciences
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-03-14
- Primary Completion
- 2017-09-14
- Completion
- 2020-01-30
- FDA Drug
- Yes
Countries
- United States
- Canada
Study Locations
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