Efficacy and Safety of Idelalisib (GS-1101) in Combination With Bendamustine and Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas

Conditions

• Indolent Non-Hodgkin's Lymphomas

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Idelalisib — DRUG
  150 mg tablet administered orally twice daily
• Rituximab — DRUG
  375 mg/m\^2 single-use vials administered intravenously every 4 weeks (up to a total of 6 infusions)
• Bendamustine — DRUG
  90 mg/m\^2 single-use vials administered intravenously for two consecutive days every 4 weeks (up to a total of 4-6 cycles as tolerated)
• Placebo — DRUG
  Tablet administered orally twice daily

Study Details

The primary objective of this study is to evaluate the addition of idelalisib to bendamustine/rituximab on progression-free survival (PFS) in adults with previously treated indolent non-Hodgkin lymphoma (iNHL). An increased rate of deaths and serious adverse events (SAEs) among participants with front-line chronic lymphocytic leukemia (CLL) and early-line 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

Jan 2, 2013

Status verified

Mar 2017

Primary completion

May 17, 2016

Completion

May 17, 2016

Study Design

Enrollment

475 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Rituximab + Bendamustine + Idelalisib
  Participants will receive rituximab + bendamustine + idelalisib.
• Experimental: Rituximab + Bendamustine + Placebo
  Participants will receive rituximab + bendamustine + placebo.

Primary Outcome Measure

Progression-free Survival (PFS)

Locations (33)

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