Non Hodgkin Lymphoma Clinical Trial

Study to Evaluate Efficacy, Safety, Tolerability, and Pharmacodynamics of Entospletinib in Adults With Relapsed or Refractory Hematologic Malignancies

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]).

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria:

Diagnosis of B-cell iNHL, DLBCL, MCL, or CLL as documented by medical records and with histology based on criteria established by the World Health Organization
For institutions that have Phase 3 or Phase 4 protocols studying idelalisib (Zydelig®) ; individuals with malignancies being studied in these protocols must have failed screening in the respective idelalisib protocol
Prior treatment for lymphoid malignancy requiring treatment for progressive disease
Presence of radiographically measurable lymphadenopathy or extranodal lymphoid malignancy
All acute toxic effects of any prior antitumor therapy resolved to Grade ≤ 1 before the start of study drug
Karnofsky performance status of ≥ 60
Life expectancy of at least 3 months

Key Exclusion Criteria:

Known histological transformation from iNHL or CLL to an aggressive form of non-Hodgkin lymphoma (ie, Richter transformation) except if the CLL participant is enrolling in the BCR previously treated cohort
Known active central nervous system or leptomeningeal lymphoma
Presence of known intermediate- or high-grade myelodysplastic syndrome
Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of start of study drug
Ongoing liver injury
Ongoing or recent hepatic encephalopathy
Ongoing drug-induced pneumonitis
Ongoing inflammatory bowel disease
Ongoing alcohol or drug addiction
Pregnancy or breastfeeding
History of prior allogeneic bone marrow progenitor cell or solid organ transplantation
Ongoing immunosuppressive therapy
Concurrent participation in an investigational drug trial with therapeutic intent

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

326

Study ID:

NCT01799889

Recruitment Status:

Terminated

Sponsor:

Gilead Sciences

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There are 48 Locations for this study

See Locations Near You

University of Alabama at Birmingham
Birmingham Alabama, 35294, United States
Arizona Oncology Associates
Tucson Arizona, 85710, United States
City of Hope National Medical Center
Duarte California, 91010, United States
Sharp Memorial Hospital
San Diego California, 92123, United States
Rocky Mountain Cancer Centers, LLP
Boulder Colorado, 80303, United States
Kaiser Permanente of Colorado
Denver Colorado, 80218, United States
Cancer Center of Central Connecticut
Southington Connecticut, 06489, United States
Florida Cancer - Colonial
Fort Myers Florida, 33905, United States
Memorial Cancer Institute
Hollywood Florida, 33021, United States
Ocala Oncology Center
Ocala Florida, 34471, United States
Northside Hospital
Atlanta Georgia, 30341, United States
Gwinnett Hospital System Dba The Center for Cancer Care
Lawrenceville Georgia, 30046, United States
Northwest Georgia Oncology Center
Marietta Georgia, 30060, United States
University of Chicago
Chicago Illinois, 60637, United States
Illinois Cancer Specialists
Niles Illinois, 60714, United States
Indiana University Simon Cancer Center
Indianapolis Indiana, 46202, United States
Hematology Oncology Clinic, PLLC
Baton Rouge Louisiana, 70809, United States
Tufts Medical Center
Boston Massachusetts, 02111, United States
University of Michigan Health System
Ann Arbor Michigan, 48109, United States
Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Minnesota Oncology Hematology, PA
Minneapolis Minnesota, 55404, United States
Hattiesburg Clinic
Hattiesburg Mississippi, 39401, United States
Oncology Hematology West PC dba Nebraska Cancer Specialists
Omaha Nebraska, 68130, United States
One Medical Center Drive
Lebanon New Hampshire, 03756, United States
Summit Medical Group, P.A.
Florham Park New Jersey, 07932, United States
Clinical Research Alliance
New York New York, 10021, United States
University of North Carolina
Chapel Hill North Carolina, 27599, United States
Gabrail Cancer Center Research
Canton Ohio, 44718, United States
Oncology Hematology Care
Cincinnati Ohio, 45242, United States
Cleveland Clinic
Cleveland Ohio, 44195, United States
Ohio State University Comprehensive Cancer Center
Columbus Ohio, 43210, United States
Williamette Valley Cancer Center and Research Institute
Springfield Oregon, 97477, United States
Prairie Lakes Health Care System, Inc.
Watertown South Dakota, 57201, United States
Jones Clinic PC
Germantown Tennessee, 38138, United States
Tennessee Oncology, PLLC
Nashville Tennessee, 37203, United States
Texas Oncology-Austin Midtown
Austin Texas, 78705, United States
Texas Oncology-Medical City Dallas
Dallas Texas, 75230, United States
Center for Cancer and Blood Disorders
Fort Worth Texas, 76104, United States
Cancer Care Network of South Texas
San Antonio Texas, 78217, United States
Cancer Care Center of South Texas
San Antonio Texas, 78229, United States
Virginia Cancer Specialists, PC
Fairfax Virginia, 22031, United States
Virginia Cancer Institute
Richmond Virginia, 23226, United States
Columbia Basin Hematology and Oncology
Kennewick Washington, 99336, United States
University of Washington
Seattle Washington, 98109, United States
Northwest Cancer Specialists, PC
Vancouver Washington, 98684, United States
Yakima Valley Memorial Hospital North Star Lodge
Yakima Washington, 98902, United States
Royal Victoria Regional Health Centre
Barrie Ontario, L4M 6, Canada
Sir Mortimer B. Davis-Jewish General Hospital
Montreal Quebec, H3T 1, Canada

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

326

Study ID:

NCT01799889

Recruitment Status:

Terminated

Sponsor:


Gilead Sciences

How clear is this clinincal trial information?

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