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]).

View Eligibility Criteria

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.

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

66

Study ID:

NCT01796470

Recruitment Status:

Terminated

Sponsor:

Gilead Sciences

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There are 13 Locations for this study

See Locations Near You

UC San Diego Moores Cancer Center
La Jolla California, 92093, United States
Pacific Shores Medical Group
Long Beach California, 90813, United States
Ventura County Hematology Oncology Specialists
Oxnard California, 93030, United States
Cancer Center of Santa Barbara
Santa Barbara California, 93105, United States
Georgetown University Medical Center
Washington District of Columbia, 20007, United States
Collaborative Research Group LLC
Boynton Beach Florida, 33435, United States
Weill Cornell Medical College
New York New York, 10021, United States
University of Rochester, James P. Wilmot Cancer Center
Rochester New York, 14642, United States
Signal Point Clinical Research Center, LLC
Middletown Ohio, 45042, United States
Oregon Health and Science University
Portland Oregon, 97239, United States
Charleston Hematology Oncology
Charleston South Carolina, 29414, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States
Northwest Medical Specialties
Tacoma Washington, 98405, United States

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

66

Study ID:

NCT01796470

Recruitment Status:

Terminated

Sponsor:


Gilead Sciences

How clear is this clinincal trial information?

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