A Randomized, Double-Blind and Placebo-Controlled Study of Idelalisib in Combination With Bendamustine and Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL)

Status: Recruiting
Phase: Phase 3
Diagnosis: Leukemia/MDS
NCT ID: NCT01569295 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-480

 

This Phase 3, randomized, double-blind, placebo-controlled study is to evaluate the effect of idelalisib on the onset, magnitude, and duration of tumor control. Eligible patients will be randomized with a 1:1 ratio into 1 of the 2 treatment arms to receive either idelalisib or placebo. All subjects will be administered bendamustine and rituximab.

 

Conducting Institutions:
Brigham and Women's Hospital, Dana-Farber Cancer Institute, Beth-Israel Deaconess Medical Center

Overall PI:
Jennifer Brown, MD, PhD, Dana-Farber Cancer Institute

Site-responsible Investigators:
Jon Arnason, MD, Beth Israel Deaconess Medical Center

Contacts:
Dana-Farber Cancer Institute: Ilene Galinsky, 617-632-3902, igalinsky@partners.org
Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060

Eligibility Criteria

Inclusion: - Previously treated recurrent CLL - Measurable lymphadenopathy - Requires therapy for CLL - Has experienced CLL progression <36 months since the completion of the last prior therapy Exclusion: - Recent history of a major non-CLL malignancy - Evidence of an ongoing infection - CLL refractory to bendamustine - Concurrent participation in another therapeutic clinical trial
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