Idelalisib in Combination With Rituximab for Previously Untreated Follicular Lymphoma and Small Lymphocytic Lymphoma

Follicular Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02258529
• Other study ID #: GS-US-313-1414
• Status: Terminated
• Phase: Phase 2
• Start date: September 14, 2015
• Est. completion date: May 3, 2016

Study information

• Verified date: April 2017
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: May 3, 2016
• Est. primary completion date: April 12, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Follicular Lymphoma
• Leukemia, Lymphocytic, Chronic, B-Cell
• Lymphoma
• Lymphoma, Follicular
• Small Lymphocytic Lymphoma

Intervention

Drug:
• Idelalisib
150 tablets administered orally twice daily

Biological:
• Rituximab
375 mg/m^2 administered intravenously (weekly for 4 weeks and then every 8 weeks from Week 12 up to Week 100)

Locations

Country	Name	City	State
United States	St. Agnes Hospital	Baltimore	Maryland
United States	Florida Cancer Specialists	Fort Myers	Florida
United States	Pacific Shores Medical Group	Long Beach	California
United States	Tennessee Oncology, PLLC	Nashville	Tennessee
United States	Northwest Medical Specialties, PLLC	Tacoma	Washington
United States	Prarie Lakes Health Care Systems, Inc.	Watertown	South Dakota

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate	Overall response rate (ORR) was defined as the proportion of participants who achieve a confirmed complete or partial response during idelalisib treatment. ORR was to be assessed by an independent review committee (IRC).
Secondary	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		Up to 24 weeks plus 30 days
Secondary	Rate of Grade = 3 Transaminase Elevations Based on Laboratory Findings	The rate of Grade = 3 transaminase elevations was defined as the number of participants with any Grade 3 or 4 alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevations.	Up to 24 weeks plus 30 days
Secondary	Idelalisib Trough and Peak Plasma Concentrations		Predose and 1.5 hour postdose at Weeks 2, 4, and 12
Secondary	Time to Response	Time to response was defined as the the interval from the start of idelalisib treatment to the first documentation of complete or partial response.
Secondary	Duration of Response	Duration of response (DOR) was defined as the interval from the first documentation of complete response or partial response to the earlier of the first documentation of disease progression or death from any cause.
Secondary	Progression-Free Survival	Progression-free survival (PFS) was defined as the interval from the start of idelalisib treatment to the earlier of the first documentation of disease progression or death from any cause.
Secondary	Overall Survival	Overall survival was defined as the interval from enrollment to death from any cause.
Secondary	Changes in Health-Related Quality of Life	Changes in health-related quality of life was to be reported by participants using the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) questionnaire.