Study Evaluating the Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL) (Tugela )

Gilead Sciences

Status and phase: Completed; Phase 3

Conditions: Chronic Lymphocytic Leukemia

Treatments: Drug: Rituximab; Drug: Placebo to match idelalisib; Drug: Bendamustine; Drug: Idelalisib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01569295

2011-006292-20 (EudraCT Number)

GS-US-312-0115

Details and patient eligibility

About

The primary objective of this study is to evaluate the effect of the addition of idelalisib (formerly GS-1101) to bendamustine + rituximab (BR) on progression-free survival (PFS) in participants with previously treated chronic lymphocytic leukemia (CLL)

Enrollment: 416 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Previously treated recurrent CLL
• Measurable lymphadenopathy
• Requires therapy for CLL
• Has experienced CLL progression < 36 months since the completion of the last prior therapy

Key Exclusion Criteria:

• Recent history of a major non-CLL malignancy
• Evidence of an ongoing infection
• CLL refractory to bendamustine
• Concurrent participation in another therapeutic clinical trial

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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416 participants in 2 patient groups, including a placebo group

Idelalisib+bendamustine+rituximab

Experimental group

Description:

Participants will receive idelalisib plus bendamustine and rituximab

Treatment:

Drug: Idelalisib

Drug: Rituximab

Drug: Bendamustine

Placebo to match idelalisib+bendamustine+rituximab

Placebo Comparator group

Description:

Participants will receive placebo to match idelalisib plus bendamustine and rituximab

Treatment:

Drug: Rituximab

Drug: Placebo to match idelalisib

Drug: Bendamustine