Gilead 0124: A Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination With Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas

Study Status

Open to Enrollment

Study Description

This clinical trial is for men and women with indolent non-Hodgkin lymphoma (iNHL) that has been previously treated. The study is evaluating an experimental drug called idelalisib (also called GS-1101, previously CAL-101) in combination with a standard drug, rituximab.

The purpose of the study is to evaluate the effectiveness of idelalisib combined with rituximab in treating iNHL. Idelalisib blocks some of the cell functions that cause iNHL to grow and survive. Rituximab is FDA-approved for treating iNHL. It is possible that giving rituximab together with idelalisib may have more activity against iNHL than giving rituximab alone.

Study participants will be randomly assigned to one of two treatment groups:
  • Group 1: rituximab + idelalisib
  • Group 2: rituximab + placebo (a tablet that looks like idelalisib but contains no medicine)

Participants have a 2:1 chance of being assigned to Group 1 vs. Group 2, meaning participants are twice as likely to receive rituximab and idelalisib. Participants in both treatment groups will receive 8 rituximab infusions over 36 weeks. Participants will take idelalisib tablets by mouth twice daily.

Participants will continue on idelalisib/placebo as long as they are responding to therapy and not experiencing unacceptable side effects.

Disease Status and/or Stage

Previously Treated Indolent non-Hodgkin Lymphoma

Sponsor

Gilead

Key Eligibility

  • Men and women age 18 and older
  • B-cell indolent non-Hodgkin lymphoma (iNHL)
  • Have received prior therapy containing anti-CD20 antibody
  • iNHL is not refractory to rituximab
  • Detailed eligibility reviewed when you contact the study team

Principal Investigator

Peter Martin, MD

Contact

Protocol ID

Gilead 0124

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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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