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.



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