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

Conditions

• Chronic Lymphocytic Leukemia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Idelalisib — DRUG
  150 mg tablet administered orally twice daily
• Bendamustine — DRUG
  Administered intravenously at a starting dose of 90 mg/m\^2 for up to 6 cycles. Dosing will be based on mg/m\^2 of body surface area.
• Rituximab — DRUG
  Single-use vials administered intravenously weekly starting at 375 mg/m\^2 on Day 1 (Week 0) and 500 mg/m\^2 thereafter for a total of 6 infusions
• Placebo — DRUG
  Placebo to match idelalisib administered orally twice daily

Study Details

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).

Key Dates

Start date

Feb 5, 2014

Status verified

Sep 2017

Primary completion

May 30, 2016

Completion

Jun 16, 2016

Study Design

Enrollment

311 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Idelalisib+bendamustine+rituximab
  Participants will receive idelalisib for 96 weeks plus bendamustine+rituximab for 21 weeks.
• Placebo Comparator: Placebo+bendamustine+rituximab
  Participants will receive placebo to match idelalisib for 96 weeks plus bendamustine+rituximab for 21 weeks.

Primary Outcome Measure

Progression-Free Survival [ Time Frame: Up to 22 months ]

Locations (23)

Find similar trials in Fullerton, CA

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