Idelalisib in Combination With Rituximab for Previously Untreated Follicular Lymphoma and Small Lymphocytic Lymphoma
Conditions
Follicular Lymphoma - Small Lymphocytic Lymphoma
Conditions: official terms
Leukemia, Lymphocytic, Chronic, B-Cell - Lymphoma - Lymphoma, Follicular
Conditions: Keywords
Cancer, Indolent Non-Hodgkin Lymphoma, FL, SLL
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Idelalisib Type: Drug
Name: Rituximab Type: Biological
Overall Status
Not yet recruiting
Summary
This study of idelalisib in combination with rituximab will evaluate the overall response rate (ORR), complete response (CR) rate, overall safety profile, impact on liver function, progression-free survival (PFS), and duration of response (DOR) in participants with follicular lymphoma (FL) and small lymphocytic lymphoma (SLL) who have not received prior treatment.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
Location
Start Date
September 2015
Completion Date
October 2018
Sponsors
Gilead Sciences
Source
Gilead Sciences
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page