New Clinical Trial: Ibrutinib in Combination with Bendamustine & Rituximab or R-CHOP in Subjects with Previously Treated Indolent Non-Hodgkin Lymphoma

The Weill Cornell Lymphoma Program has recently opened a new clinical trial for men and women with previously treated follicular or marginal zone lymphoma. The study sponsor is Janssen Research & Development LLC., and the principal investigator at Weill Cornell is Dr. Peter Martin. 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:

  • Open to men and women age 18 and older
  • Follicular or Marginal Zone Non-Hodgkin lymphoma
  • Relapsed or Refractory after receiving at least one prior chemotherapy regimen
  • At least one site of measurable disease
  • Detailed eligibility reviewed when you contact the study team

Study Details

The purpose of this study is to compare whether adding ibrutinib to the standard chemotherapy options for this population bendamustine & rituximab (BR) or R-CHOP results in a longer progression-free survival than BR or R-CHOP alone. The type of chemotherapy that the patient will receive will be dependent on refractory versus relapsed disease, type of indolent non-Hodgkin Lymphoma, and number of prior lines of therapy.

Treatment Plans

All participants will be randomized (randomly) in a one to one ratio to receive the study drug, ibrutinib, or placebo.

Randomization arms: This study is comparing BR or R-CHOP in combination with ibrutinib or placebo. This is a double blind study so neither the patient or the physician will know if they are receiving the study medication, ibrutinib or placebo. The placebo is a blank pill that will look similar to ibrutinib but contains no medicine. The physicians will decide whether patients will receive BR or R-CHOP chemotherapy depending on prior treatments.

Patients will receive the standard 6 cycles of BR or R-CHOP and will continue taking ibrutinib or placebo as long as they are responding to therapy and not experiencing unacceptable side effects.

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

Update: this study is closed to enrollment. 

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.