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

• Status: Terminated
• Trial end date: 2020-01-30
• Target enrollment: 0
• Participant gender: All

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]).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences

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.