Gilead 0119: A Phase 3, Randomized, Controlled Study Evaluating the Efficacy and Safety of GS 1101 (CAL-101) in Combination with Ofatumumab for Previously Treated Chronic Lymphocytic Leukemia

Study Status

Open to Enrollment

Study Description

This clinical trial is for men and women with previously treated chronic lymphocytic leukemia (CLL). The study is evaluating the effectiveness of the experimental drug GS-1101 (Idelalisib, previously called CAL-101) in combination with the standard drug ofatumumab in treating CLL.

GS-1101 (CAL-101) is a pill designed to block some of the cell functions that cause CLL to grow and survive and may help control the disease. Ofatumumab, which is FDA-approved for treating CLL, kills CLL cells. It is possible that giving ofatumumab together with GS-1101 may be more effective than giving ofatumumab alone.

Study participants will be randomly assigned to one of two treatment groups:

  • Group 1: GS-1101 + Ofatumumab
  • Group 2: Ofatumumab alone

Participants have a two-thirds chance of being assigned to Group 1 (GS-1101 + Ofatumumab) and a one-third chance of being assigned to Group 2 (Ofatumumab alone).

Treatment Plan

Group 1

Participants will receive 24 weeks of therapy: GS-1101 by mouth twice a day, plus ofatumumab via infusion once a week for 8 weeks, then once a month for 4 months, for a total of 24 weeks. After 24 weeks of therapy, participants will continue on GS-1101 alone for as long as they are responding to treatment and not experiencing unacceptable side effects.

Group 2

Participants will receive 24 weeks of therapy: ofatumumab via infusion once a week for 8 weeks, then once a month for 4 months for a total of 24 weeks. Participants will then be followed for observation. 

Disease Status and/or Stage

Previously Treated Chronic Lymphocytic Leukemia (CLL)

Sponsor

Gilead

Key Eligibility

  • Men and women age 18 and older
  • Diagnosed with chronic lymphocytic leukemia (CLL)
  • Previously treated for CLL
  • Have not previously participated in a GS-1101 clinical trial
  • Detailed eligibility reviewed when you contact the study team

Principal Investigator

Richard Furman, MD

Contact

Protocol ID

Gilead 0119

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Contact Us

For general inquiries, or if you need assistance finding a study, please contact:

Robert Hagerty
Subject Recruitment Manager
Tel: (646) 962-9340
[email protected]

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