Two Newly Opened Clinical Trials Evaluate Idelalisib in Indolent non-Hodgkin Lymphoma

The Weill Cornell Lymphoma Program has recently opened two clinical trials evaluating the experimental drug idelalisib in previously treated indolent non-Hodgkin lymphomas (iNHL). The sponsor of the trials is Gilead Sciences.  The principal investigator at Weill Cornell is Dr. Peter Martin. For more information about the studies please call Amelyn Rodriguez, RN at (212) 746-1362 or e-mail Amelyn at amr2017@med.cornell.edu.

Idelalisib (GS-1101, previously CAL-101) works by blocking some of the cell functions that cause iNHL to grow and survive.

Gilead 0124: Idelalisib in Combination With Rituximab 

This study evaluates the effectiveness of idelalisib combined with rituximab in treating iNHL. 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.

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

Click here for a detailed summary of this trial.

Gilead 0125: Idelalisib in Combination With Bendamustine and Rituximab

This study evaluates the effectiveness of idelalisib combined with bendamustine and rituximab. Rituximab and bendamustine are FDA-approved for treating iNHL. It is possible that giving rituximab and bendamustine together with idelalisib is more effective in treating iNHL than giving rituximab and bendamustine alone.

Key Eligibility

  • Men and women age 18 and older
  • B-cell indolent non-Hodgkin lymphoma
  • Have received prior therapy containing anti-CD20 antibody and chemotherapy
  • iNHL is not refractory to bendamustine

Click here for a detailed summary of this trial.


ASCO 2013: Idelalisib Effective in Combination Therapy for Indolent non-Hodgkin Lymphoma

Frequently Asked QuestionsBy John P. Leonard, MD

Idelalisib (previously called CAL-101 and GS-1101) is a first-in-class selective, oral inhibitor of the PI3K-delta enzymes that while essential to the process of activation, proliferation, and survival of B cells, is also hyperactive in B-cell malignancies. The treatment has previously shown considerable promise as a both a monotherapy and a combination therapy in recurrent non-Hodgkin lymphoma and a variety of other lymphomas.

At the recent annual meeting of the American Society of Clinical Oncology in Chicago, I presented updated results from a recent combination therapy study, contrasting the tolerability and activity of the PI3K-inhibitor idelalisib with rituximab and/or bendamustine in patients with previously treated indolent non-Hodgkin lymphoma.  From the 78 patients there was an overall response rate (ORR) was 81% with a complete response (CR) of 28%. The ORR/CR for idelalisib/rituximab was 77%/20%, idelalisib/bendamustine 85%/29%, and idelalisib/bendamustine/rituximab 79%/43%, with a progression free survival of 73% after 20 months.

The study concluded that idelalisib-based combination therapy deserves further clinical development as this combination therapy is highly active and well tolerated in patients with relapsed/refractory indolent non-Hodgkin lymphoma.

For a full listing of all current clinical trials underway in the Lymphoma Program, please click here.


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

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.


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