Non Hodgkin Lymphoma Clinical Trial
Entospletinib in Combination With Idelalisib in Adults With Relapsed or Refractory Hematologic Malignancies
Summary
This study will evaluate the efficacy of the combination entospletinib and idelalisib in participants with relapsed or refractory hematologic malignancies. Participants will be enrolled who have one of the following hematological tumor types: chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), diffuse large B-cell lymphoma (DLBCL), or indolent non-Hodgkin lymphomas (iNHL; including follicular lymphoma (FL) and lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia [LPL/WM], small lymphocytic lymphoma [SLL], or marginal zone lymphoma [MZL]).
Eligibility Criteria
Key Inclusion Criteria:
Diagnosis of B-cell indolent non-Hodgkin lymphoma (iNHL),diffuse large B-cell lymphoma (DLBCL),mantle cell lymphoma (MCL), or chronic lymphocytic leukemia (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®; GS-1101); individuals with malignancies being studied in these protocols must have failed screening and be registered as a screen failure in the respective idelalisib protocol
Prior treatment for lymphoid malignancy
Presence of radiographically measurable lymphadenopathy or extranodal lymphoid malignancy
Discontinuation of all therapy for the treatment of cancer ≥ 3 weeks before the start of study drug
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 NHL (ie, Richter transformation)
Known active central nervous system or leptomeningeal lymphoma
Presence of known intermediate- or high-grade myelodysplastic syndrome
Current therapy with agents that reduce gastric acidity, including but not limited to antacids, H2 inhibitors, and proton pump inhibitors
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 13 Locations for this study
La Jolla California, 92093, United States
Long Beach California, 90813, United States
Oxnard California, 93030, United States
Santa Barbara California, 93105, United States
Washington District of Columbia, 20007, United States
Boynton Beach Florida, 33435, United States
New York New York, 10021, United States
Rochester New York, 14642, United States
Middletown Ohio, 45042, United States
Portland Oregon, 97239, United States
Charleston South Carolina, 29414, United States
Houston Texas, 77030, United States
Tacoma Washington, 98405, United States
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