New Clinical Trial: GS-1101 in Combination with Bendamustine and Rituximab for Previously Treated CLL

Update: this study is closed to enrollment. 

The Weill Cornell Lymphoma Program is now recruiting men and women with previously treated, recurrent chronic lymphocytic leukemia (CLL) for a clinical trial evaluating the experimental drug GS-1101 (also called Idelalisib, formerly called CAL-101), combined with bendamustine and rituximab, in treating CLL. The study sponsor is Gilead Sciences, Inc, and the principal investigator at Weill Cornell is Dr. Richard Furman. For more information about the study, please call Amelyn Rodgriguez, RN at (212) 746-1362 or e-mail Amelyn at amr2017@med.cornell.edu.

Key Eligibility
  • Age 18 and older
  • Diagnosis of B-cell chronic lymphocytic leukemia (CLL)
  • Previously treated for CLL
  • Detailed eligibility reviewed when you contact the study team
Study Details

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. Rituximab and bendamustine are approved by the FDA as a treatment for CLL. The study will help determine whether adding GS-1101 (CAL-101) to the standard treatment of rituximab and bendamustine will have a better effect on controlling CLL.

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

  • Group A: GS-1101 and rituximab/bendamustine
  • Group B: Rituximab/bendamustine and placebo (an inactive pill that looks like GS-1101 but contains no medicine)

After 20 weeks of therapy with rituximab, bendamustine and GS-1101 or placebo, participants will continue with GS-1101 or placebo as long as their CLL is controlled.

New Clinical Trial: GS-1101 (CAL-101) + Rituximab for Previously Treated CLL

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of GS 1101 (CAL 101) in Combination with Rituximab for Patients with Previously Treated Chronic Lymphocytic Leukemia

Update: this study is closed to enrollment. 

The Weill Cornell Lymphoma Program is now enrolling patients in a new clinical trial for people with previously treated Chronic Lymphocytic Leukemia (CLL). The sponsor is Gilead Sciences, and the principal investigator at Weill Cornell is Dr. Richard Furman. For more information about the study, please call Amelyn Rodriguez, RN at (212) 746-1362 or email Amelyn at amr2017@med.cornell.edu.

Study Details

The study will evaluate the effectiveness of the experimental drug GS-1101 (CAL-101) combined with rituximab 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. Rituximab is FDA-approved as a treatment for CLL. It is possible that giving rituximab together with GS-1101 may have more activity against the CLL disease process than giving rituximab alone.

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

  • Group A: rituximab and GS-1101
  • Group B: rituximab and placebo (an inactive pill that looks like GS-1101 but contains no medicine)

Treatment Plan

All study participants will receive rituximab via infusion 8 times over 24 weeks: Day 1, then Weeks 2, 4, 6, 8, 12, 16 and 20.

Participants will take GS-1101 or placebo twice daily for 24 weeks.

After 24 weeks of therapy with rituximab and GS-1101 or placebo, participants will continue on GS-1101 or placebo as long as their CLL is controlled. If their CLL gets worse, participants may be able to take part in a separate extension study where they receive GS-1101 at a higher or lower dose. Thus, everyone who is treated in this study has an opportunity to receive active GS-1101, either in the main study or the extension study.

Study of CAL-101 in Patients With Indolent B-Cell Non-Hodgkin Lymphoma

Update: this study is closed to enrollment. 

The Weill Cornell Lymphoma Program is enrolling patients in a clinical trial testing the experimental drug CAL-101. The study evaluates the efficacy and safety of CAL-101 in patients with previously treated indolent Non-Hodgkin Lymphoma (iNHL) that is refractory both to rituximab and to alkylating-agent-containing chemotherapy. The principal investigator at Weill Cornell is Dr. Peter Martin.

All cells in the body receive signals to grow and survive, but sometimes these signals can get out of control, causing too much cell growth. When cell growth gets out of control, cancers like iNHL can develop. CAL-101 blocks some of the cell functions that cause iNHL to grow and survive. By blocking these functions, CAL-101 may reduce or prevent iNHL from growing and surviving. Results from earlier studies suggest that CAL-101 may help control iNHL.

This is a clinical trial for people with the following types of B-cell indolent non-Hodgkin lymphoma (iNHL):

  • follicular lymphoma
  • small lymphocytic lymphoma
  • lymphoplasmacytoid lymphoma
  • marginal zone lymphoma

Study participants must have received at least 2 different prior treatments for iNHL, and at some point during prior therapy they must have received rituximab and a type of chemotherapy called an alkylating agent.

The purpose of the study is to determine whether the investigational drug CAL-101 is safe and effective for treating people with iNHL once their iNHL has become too difficult to control with available therapies.

CAL-101 is a tablet. Study participants will take CAL-101 twice per day. Participants will be seen for study visits:

  • every 2 weeks for the first 12 weeks of study treatment
  • every 4 weeks until Week 24
  • every 6 weeks until Week 48
  • every 12 weeks until the end of the study

For more information, please call June Greenberg, RN at (212) 746-2651 or email June at jdg2002@med.cornell.edu.