Efficacy and Safety of Idelalisib in Combination With Rituximab in Patients With Previously Untreated Chronic Lymphocytic Leukemia With 17p Deletion

Conditions

• B-cell Chronic Lymphocytic Leukemia (CLL) With 17p Deletion

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Idelalisib — DRUG
  150 mg tablets administered orally twice daily
• Rituximab — DRUG
  375 mg/m\^2 administered intravenously once weekly x 8 weeks

Study Details

The primary objective of this study is to evaluate overall response rate (ORR) following treatment with idelalisib plus rituximab in participants with previously untreated chronic lymphocytic leukemia (CLL) with 17p deletion. 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 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.

Key Dates

Start date

Aug 6, 2014

Status verified

Mar 2017

Primary completion

Apr 27, 2016

Completion

May 17, 2016

Study Design

Enrollment

102 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Idelalisib + rituximab
  Participants will receive rituximab for 8 weeks and Idelalisib continuously throughout the study (up to 10 years).

Primary Outcome Measure

Overall Response Rate

Locations (11)

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