Clinical trial NCT02258529: Idelalisib in Combination With Rituximab for Previously Untreated Follicular Lymphoma and Small Lymphocytic Lymphoma
Official title: A Phase 2, Single Arm Study Evaluating the Safety and Efficacy of Idelalisib in Combination With Rituximab for Previously Untreated Follicular Lymphoma and Small Lymphocytic Lymphoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Follicular Lymphoma
Small Lymphocytic Lymphoma
Keywords: Cancer
Indolent Non-Hodgkin Lymphoma
FL
SLL
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2014-10-07
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 adults with follicular lymphoma (FL) or small lymphocytic lymphoma (SLL).

An increased rate of deaths and serious adverse events (SAEs) among participants with front-line chronic lymphocytic leukemia (CLL) and early-line indolent non-Hodgkin lymphoma (iNHL) treated with idelalisib in combination with standard therapies was observed by the independent data monitoring committee (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data and terminated those studies in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA). All front-line studies of idelalisib, including this study, were also terminated.


Eligibility criteria: Key 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

Key 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

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Overall Response Rate
Secondary outcomes:
measure: Overall Safety Profile of Idelalisib as Measured by the Incidence of Adverse Events (AEs), Severe AEs (SAEs), AEs Leading to Idelalisib (IDL) Interruption, Idelalisib Dose Reduction, Premature Discontinuation of Idelalisib, or Death
timeFrame: Up to 24 weeks plus 30 days
measure: Rate of Grade ≥ 3 Transaminase Elevations Based on Laboratory Findings
timeFrame: Up to 24 weeks plus 30 days
measure: Idelalisib Trough and Peak Plasma Concentrations
timeFrame: Predose and 1.5 hour postdose at Weeks 2, 4, and 12
measure: Time to Response
measure: Duration of Response
measure: Progression-Free Survival
measure: Overall Survival
measure: Changes in Health-Related Quality of Life
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Pacific Shores Medical Group
state: California
city: Fort Myers
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Baltimore
country: United States
facility: St. Agnes Hospital
state: Maryland
city: Watertown
country: United States
facility: Prarie Lakes Health Care Systems, Inc.
state: South Dakota
city: Nashville
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Tacoma
country: United States
facility: Northwest Medical Specialties, PLLC
state: Washington
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References: