Idelalisib in Combination With Rituximab for Previously Untreated Follicular Lymphoma and Small Lymphocytic Lymphoma
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|ClinicalTrials.gov Identifier: NCT02258529|
Recruitment Status : Terminated
First Posted : October 7, 2014
Results First Posted : May 18, 2017
Last Update Posted : May 14, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Follicular Lymphoma Small Lymphocytic Lymphoma||Drug: Idelalisib Biological: Rituximab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||September 14, 2015|
|Actual Primary Completion Date :||April 12, 2016|
|Actual Study Completion Date :||May 3, 2016|
Experimental: Idelalisib + rituximab
Idelalisib + rituximab for up to 104 weeks
150 tablets administered orally twice daily
375 mg/m^2 administered intravenously (weekly for 4 weeks and then every 8 weeks from Week 12 up to Week 100)
- Overall Response RateOverall 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).
- 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 [ Time Frame: Up to 24 weeks plus 30 days ]
- Rate of Grade ≥ 3 Transaminase Elevations Based on Laboratory Findings [ Time Frame: Up to 24 weeks plus 30 days ]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.
- Idelalisib Trough and Peak Plasma Concentrations [ Time Frame: Predose and 1.5 hour postdose at Weeks 2, 4, and 12 ]
- Time to ResponseTime to response was defined as the the interval from the start of idelalisib treatment to the first documentation of complete or partial response.
- Duration of ResponseDuration 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.
- Progression-Free SurvivalProgression-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.
- Overall SurvivalOverall survival was defined as the interval from enrollment to death from any cause.
- Changes in Health-Related Quality of LifeChanges in health-related quality of life was to be reported by participants using the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) questionnaire.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02258529
|United States, California|
|Pacific Shores Medical Group|
|Long Beach, California, United States, 90813|
|United States, Florida|
|Florida Cancer Specialists|
|Fort Myers, Florida, United States, 33916|
|United States, Maryland|
|St. Agnes Hospital|
|Baltimore, Maryland, United States, 21229|
|United States, South Dakota|
|Prarie Lakes Health Care Systems, Inc.|
|Watertown, South Dakota, United States, 57201|
|United States, Tennessee|
|Tennessee Oncology, PLLC|
|Nashville, Tennessee, United States, 37203|
|United States, Washington|
|Northwest Medical Specialties, PLLC|
|Tacoma, Washington, United States, 98405|
|Study Director:||Gilead Study Director||Gilead Sciences|