Tag: ibrutinib

New Clinical Trial: Phase 3 Study of Ibrutinib in Combination with Either Bendamustine and 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 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 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 

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.

Dr. Peter Martin Explains a Trial Testing the Combination of Ibrutinib + Palbociclib for Patients with Previously Treated Mantle Cell Lymphoma

In this video Dr. Peter Martin explains the benefits of a recently opened phase I trial of ibrutinib plus palbociclib for patients with previously treated mantle cell lymphoma (MCL). The trial will evaluate the safety and activity of the combination. This is a Weill Cornell Medical College investigator-initiated clinical trial, sponsored by the Cancer Therapy Evaluation Program at the National Cancer Institute.

If you’re interested in participating in this trial please call 646-962-2074 for more information.

FDA Approves Ibrutinib for the Treatment of Patients with Waldenstrom’s Macroglobulinemia

Earlier today the FDA announced the expanded approval of ibrutinib in the treatment of patients with Waldenstrom’s Macroglobulinemia. Ibrutinib had previously received a “breakthrough therapy” designation for this use.

“The FDA based its approval of Imbruvica for WM on a clinical study of 63 previously treated participants. All study participants received a daily 420 milligram orally administered dose of the medication until disease progression or side effects became intolerable. Results showed 62 percent of participants had their cancer shrink after treatment (overall response rate). At the time of the study, the duration of response ranged from 2.8 months to approximately 18.8 months.”

This is the fourth lymphoma related indication that ibrutinib has received approval to treat. Previously the drug received approval for the treatment of patients with  mantle cell lymphoma who received one prior therapy, patients with previously treated chronic lymphocytic leukemia (CLL), and treatment of CLL patients who carry a deletion in chromosome 17. Currently, further studies with ibrutinib for patients with Waldenstrom’s are ongoing at Weill Cornell. 

Finally, we would like to recognize all the patients with WM that have participated in these trials at WCMC and elsewhere for making FDA approval of this groundbreaking drug a reality.