Extension Study of Idelalisib in Participants With Chronic Lymphocytic Leukemia (CLL) Who Participated in GS-US-312-0116 (NCT01539512)

Gilead Sciences

Status and phase: Terminated; Phase 3

Conditions: Chronic Lymphocytic Leukemia

Treatments: Drug: Idelalisib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01539291

GS-US-312-0117

2011-006293-72 (EudraCT Number)

Details and patient eligibility

About

The primary objective of this extension study (GS-US-312-0117) that is a companion study to Study GS-US-312-0116 (NCT01539512), is to evaluate the effect of idelalisib on the onset, magnitude, and duration of tumor control. Randomization was done in study GS-US-312-0116, and carried forward to study GS-US-312-117.

Enrollment: 161 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Individuals in the primary Phase 3 study (Study GS-US-312-0116) who are compliant
• Tolerating primary study therapy

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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161 participants in 2 patient groups

High-dose Idelalisib

Experimental group

Description:

Participants will receive idelalisib 300 mg twice daily (600 mg per day).

Treatment:

Drug: Idelalisib

Standard-dose Idelalisib

Experimental group

Description:

Participants will receive idelalisib 150 mg twice daily (300 mg per day)

Treatment:

Drug: Idelalisib