The Weill Cornell Lymphoma Program has recently opened a new clinical trial for men and women with follicular and marginal zone lymphoma. The study sponsor is Janssen Research & Development LLC., and the principal investigator at Weill Cornell is Peter Martin, M.D.. 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.
This clinical trial is for men and women with follicular or marginal zone lymphoma who have been previously treated.
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 result in a longer progression-free survival than BR or R-CHOP alone.
The type of chemotherapy received 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 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 you’re receiving the study medication, ibrutinib or placebo. 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.