Status:
TERMINATED
Idelalisib in Combination With Rituximab for Previously Untreated Follicular Lymphoma and Small Lymphocytic Lymphoma
Lead Sponsor:
Gilead Sciences
Conditions:
Follicular Lymphoma
Small Lymphocytic Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The primary objective of this study is to evaluate the overall response rate (ORR) and complete response (CR) rate to treatment with idelalisib in combination with rituximab in previously untreated ad...
Eligibility Criteria
Inclusion
- Key
- Histologically confirmed diagnosis of B-cell lymphoma
- No previous systemic treatment for lymphoma
- Subject demonstrates need for treatment for lymphoma
- Ann-Arbor Stage 2 (noncontiguous), 3, or 4 disease
- Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy
- Adequate performance status
- Required baseline laboratory data within protocol-specified parameters
- Key
Exclusion
- Known history of transformed lymphoma or diffuse large cell lymphoid malignancy
- Known history of, or clinically apparent, central nervous system (CNS) lymphoma or leptomeningeal lymphoma
- Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of enrollment
- Known history of drug-induced liver injury, chronic active hepatitis B (HBV), chronic active hepatitis C (HCV), alcoholic liver disease, non-alcoholic steatohepatitis, cirrhosis of the liver, portal hypertension, primary biliary cirrhosis, or ongoing extrahepatic obstruction caused by cholelithiasis
- Ongoing inflammatory bowel disease
- Known human immunodeficiency virus (HIV) infection
- History of prior allogeneic bone marrow progenitor cell or solid organ transplantation
- Ongoing immunosuppressive therapy, including systemic corticosteroids (\> 10 mg prednisone or equivalent/day) with the exception of the use of topical, enteric, or inhaled corticosteroids as therapy for comorbid conditions and systemic steroids for autoimmune anemia and/or thrombocytopenia
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
September 14 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 3 2016
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT02258529
Start Date
September 14 2015
End Date
May 3 2016
Last Update
May 14 2019
Active Locations (6)
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1
Pacific Shores Medical Group
Long Beach, California, United States, 90813
2
Florida Cancer Specialists
Fort Myers, Florida, United States, 33916
3
St. Agnes Hospital
Baltimore, Maryland, United States, 21229
4
Prarie Lakes Health Care Systems, Inc.
Watertown, South Dakota, United States, 57201