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

Gilead Sciences

Status and phase: Terminated; Phase 3

Conditions: Indolent Non-Hodgkin's Lymphomas

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01732913

GS-US-313-0124

Details and patient eligibility

About

The primary objective of this study is to evaluate the effect of the addition of idelalisib to 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: 295 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) with absolute lymphocyte count < 5 x 10^9/L at the time of diagnosis
  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.
• Received previous treatment with rituximab 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

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295 participants in 2 patient groups, including a placebo group

Rituximab + idelalisib

Experimental group

Description:

Participants will receive rituximab + idelalisib.

Treatment:

Drug: Idelalisib

Drug: Rituximab

Rituximab + Placebo

Placebo Comparator group

Description:

Participants will receive rituximab + placebo. Following confirmation of iNHL disease progression by the independent review committee and unblinding, participants may be eligible to receive open-label idelalisib 150 mg twice daily.

Treatment:

Drug: Idelalisib

Drug: Placebo

Drug: Rituximab