Status:
TERMINATED
Study to Evaluate Efficacy, Safety, Tolerability, and Pharmacodynamics of Entospletinib in Adults With Relapsed or Refractory Hematologic Malignancies
Lead Sponsor:
Gilead Sciences
Conditions:
Chronic Lymphocytic Leukemia
Mantle Cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
March 14 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2020
Estimated Enrollment :
326 Patients enrolled
Trial Details
Trial ID
NCT01799889
Start Date
March 14 2013
End Date
January 30 2020
Last Update
November 19 2020
Active Locations (48)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Arizona Oncology Associates
Tucson, Arizona, United States, 85710
3
City of Hope National Medical Center
Duarte, California, United States, 91010
4
Sharp Memorial Hospital
San Diego, California, United States, 92123