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]).
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.
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There are 48 Locations for this study
Birmingham Alabama, 35294, United States
Tucson Arizona, 85710, United States
Duarte California, 91010, United States
San Diego California, 92123, United States
Boulder Colorado, 80303, United States
Denver Colorado, 80218, United States
Southington Connecticut, 06489, United States
Fort Myers Florida, 33905, United States
Hollywood Florida, 33021, United States
Ocala Florida, 34471, United States
Atlanta Georgia, 30341, United States
Lawrenceville Georgia, 30046, United States
Marietta Georgia, 30060, United States
Chicago Illinois, 60637, United States
Niles Illinois, 60714, United States
Indianapolis Indiana, 46202, United States
Baton Rouge Louisiana, 70809, United States
Boston Massachusetts, 02111, United States
Ann Arbor Michigan, 48109, United States
Detroit Michigan, 48201, United States
Minneapolis Minnesota, 55404, United States
Hattiesburg Mississippi, 39401, United States
Omaha Nebraska, 68130, United States
Lebanon New Hampshire, 03756, United States
Florham Park New Jersey, 07932, United States
New York New York, 10021, United States
Chapel Hill North Carolina, 27599, United States
Canton Ohio, 44718, United States
Cincinnati Ohio, 45242, United States
Cleveland Ohio, 44195, United States
Columbus Ohio, 43210, United States
Springfield Oregon, 97477, United States
Watertown South Dakota, 57201, United States
Germantown Tennessee, 38138, United States
Nashville Tennessee, 37203, United States
Austin Texas, 78705, United States
Dallas Texas, 75230, United States
Fort Worth Texas, 76104, United States
San Antonio Texas, 78217, United States
San Antonio Texas, 78229, United States
Fairfax Virginia, 22031, United States
Richmond Virginia, 23226, United States
Kennewick Washington, 99336, United States
Seattle Washington, 98109, United States
Vancouver Washington, 98684, United States
Yakima Washington, 98902, United States
Barrie Ontario, L4M 6, Canada
Montreal Quebec, H3T 1, Canada
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