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Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab in Adults With Previously Untreated Chronic Lymphocytic Leukemia

Phase 3
Terminated
Conditions
Chronic Lymphocytic Leukemia
Interventions
Registration Number
NCT01980888
Lead Sponsor
Gilead Sciences
Brief Summary

The primary objective of this study is to evaluate the progression-free survival in participants with previously untreated chronic lymphocytic leukemia (CLL) who would otherwise be suitable for bendamustine and rituximab treatment as standard of care.

An increased rate of deaths and serious adverse events (SAEs) among participants with front-line 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 this study in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA).

Detailed Description

Not available

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
311
Inclusion Criteria
  • Documented diagnosis of B-cell CLL, with diagnosis established according to International Workshop on Chronic Lymphocytic Leukemia (IWCLL)
  • No prior therapy for CLL other than corticosteroids for disease complications
  • CLL that warrants treatment
  • Presence of measurable lymphadenopathy
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2

Key

Exclusion Criteria
  • Known histological transformation from CLL to an aggressive lymphoma (ie, Richter transformation)
  • Known presence of myelodysplastic syndrome
  • Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of randomization
  • Ongoing liver injury
  • History of non-infectious pneumonitis
  • Ongoing inflammatory bowel disease
  • History of prior allogeneic bone marrow progenitor cell or solid organ transplantation
  • Ongoing immunosuppressive therapy other than corticosteroids
  • Received last dose of study drug on another therapeutic clinical trial within 30 days prior to randomization

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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Placebo+bendamustine+rituximabRituximabParticipants will receive placebo to match idelalisib for 96 weeks plus bendamustine+rituximab for 21 weeks.
Idelalisib+bendamustine+rituximabBendamustineParticipants will receive idelalisib for 96 weeks plus bendamustine+rituximab for 21 weeks.
Placebo+bendamustine+rituximabPlaceboParticipants will receive placebo to match idelalisib for 96 weeks plus bendamustine+rituximab for 21 weeks.
Idelalisib+bendamustine+rituximabIdelalisibParticipants will receive idelalisib for 96 weeks plus bendamustine+rituximab for 21 weeks.
Placebo+bendamustine+rituximabBendamustineParticipants will receive placebo to match idelalisib for 96 weeks plus bendamustine+rituximab for 21 weeks.
Idelalisib+bendamustine+rituximabRituximabParticipants will receive idelalisib for 96 weeks plus bendamustine+rituximab for 21 weeks.
Primary Outcome Measures
NameTimeMethod
Progression-Free SurvivalUp to 22 months

Progression-free survival (PFS) is defined as the interval from randomization to the first documentation of definitive disease progression or death from any cause. Definitive disease progression is CLL progression based on standard criteria, excluding lymphocytosis alone. PFS was to be assessed by an independent review committee (IRC).

Secondary Outcome Measures
NameTimeMethod
Overall Response RateUp to 22 months

Overall response rate (ORR) is defined as the proportion of participants who achieve a confirmed complete or partial response. ORR was to be assessed by an IRC.

Minimal Residual Disease Negativity Rate at Week 36Up to 22 months

Minimal residual disease (MRD) negativity rate is defined as the proportion of participants with MRD \< 10\^-4 assessed by flow cytometry in bone marrow at Week 36 after therapy initiation or at least 12 weeks after the last dose of rituximab or bendamustine (whichever is later) for participants receiving the final dose of rituximab after the original scheduled date. MRD negativity rate was to be assessed by an IRC.

Overall SurvivalUp to 22 months

Overall survival is defined as the interval from randomization to death from any cause. Overall survival was to be assessed by an IRC.

Nodal Response RateUp to 22 months

Nodal response rate is defined as the proportion of participants who achieve a 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters of index lesions. Nodal response rate was to be assessed by an IRC.

Complete Response RateUp to 22 months

Complete response rate is defined as the proportion of participants who achieve a confirmed complete response. Complete response rate was to be assessed by an IRC.

Trial Locations

Locations (90)

St. Jude Heritage Healthcare Virginia K. Crosson Cancer Center

🇺🇸

Fullerton, California, United States

UCSD Moores Cancer Center

🇺🇸

La Jolla, California, United States

Central Coast Medical Oncology

🇺🇸

Santa Maria, California, United States

Georgetown University

🇺🇸

Washington, District of Columbia, United States

Memorial Healthcare System

🇺🇸

Hollywood, Florida, United States

Cancer Specialists of North Florida

🇺🇸

Jacksonville, Florida, United States

Florida Cancer Specialists-South

🇺🇸

Sarasota, Florida, United States

Franciscan Physician Network Oncology & Hematology

🇺🇸

Indianapolis, Indiana, United States

Siouxland Hematology-Oncology Associates, LLP

🇺🇸

Sioux City, Iowa, United States

Center for Cancer and Blood Disorders

🇺🇸

Bethesda, Maryland, United States

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St. Jude Heritage Healthcare Virginia K. Crosson Cancer Center
🇺🇸Fullerton, California, United States
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