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

Gilead Sciences

Status and phase: Terminated; Phase 3

Conditions: Indolent Non-Hodgkin's Lymphomas

Treatments: Drug: Placebo; Drug: Rituximab; Drug: Bendamustine; Drug: Idelalisib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01732926

2012-004034-42 (EudraCT Number)

GS-US-313-0125

Details and patient eligibility

About

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).

Enrollment: 475 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Histologically confirmed diagnosis of B-cell iNHL, with histological subtype limited to the following

  1. Follicular lymphoma (FL) Grade 1, 2, or 3a
  2. Small lymphocytic lymphoma (SLL)
  3. Lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia (LPL/WM)
  4. Marginal zone lymphoma (MZL) (splenic, nodal, or extra-nodal)

Key Exclusion Criteria:

• History of lymphoid malignancy other than those allowed per inclusion criteria.
• Ongoing drug-induced liver injury, active hepatitis C, active hepatitis B, alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, extrahepatic obstruction caused by cholelithiasis, cirrhosis of the liver, or portal hypertension.
• Prior treatment with bendamustine that was not effective.

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

475 participants in 2 patient groups

Rituximab + Bendamustine + Idelalisib

Experimental group

Description:

Participants will receive rituximab + bendamustine + idelalisib.

Treatment:

Drug: Rituximab

Drug: Idelalisib

Drug: Bendamustine

Rituximab + Bendamustine + Placebo

Experimental group

Description:

Participants will receive rituximab + bendamustine + placebo.

Treatment:

Drug: Rituximab

Drug: Bendamustine

Drug: Placebo