New Clinical Trial: Ibrutinib in Combination with Bendamustine & Rituximab or R-CHOP in Subjects with Previously Treated Indolent Non-Hodgkin LymphomaPosted: August 12, 2014
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 firstname.lastname@example.org.
- 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
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.
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.