Tag: ibrutinib

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.

New Options for Treating Patients with Ibrutinib Resistant Mantle Cell Lymphoma

Earlier today the prestigious journal Cancer Discovery published the results of our program’s latest work in mantle cell lymphoma. Although previous clinical trials have demonstrated the effectiveness of ibrutinib in treating patients with mantle cell lymphoma, researchers also noted that some patient’s lymphoma developed ibrutinib resistance during treatment. Our findings revealed some insight into why this resistance occurs and offers several potential treatment strategies for patients who develop ibrutinib resistance. Based on their findings,

“…the researchers devised two treatment strategies that they tested in lymphoma cell lines. Both involve serial use of two anti-cancer drugs — the first to weaken or “prime” the cancer cells, and the second to deliver an added impact. Both use the experimental agent palbociclib (which selectively inhibits two cell-cycle promoting proteins, CDK4 and CDK6) to slow down the cancer’s growth and sensitize cells to the killing power of a second drug.”

As the study’s lead researcher, Dr. Selina Chen-Kiang commented,

“While for many patients ibrutinib represents a valuable treatment option, it has limitations, and we have been able to demonstrate how novel therapy combinations that target the cancer’s resistance pathways might possibly work better.”

These results build on years of laboratory and clinical work at WCMC, and they highlight the need for further research such as our ongoing trial with ibrutinib plus palbociclib

If you have any questions please contact us and look to our clinical trials page for our ongoing trials.

For additional information see the press release from the American Association for Cancer Research.

FDA Expands Ibrutinib Approval for Patients with CLL

Earlier today the US FDA announced approval for the expanded use of ibrutinib (Imbruvica) to treat patients with chronic lymphocytic leukemia (CLL), who carry a deletion in chromosome 17 (17p deletion). This chromosome is often associated with poor responses to standard CLL treatments. Additionally the FDA also approved,

“…new labeling to reflect that Imbruvica’s clinical benefit in treating CLL has been verified. In February 2014, Imbruvica received accelerated approval to treat CLL based on its effect on overall response rate. New clinical trial results examining progression-free survival and overall survival have confirmed the drug’s clinical benefit.”

This approval and new labeling reflect the results of previous clinical studies of CLL patients with 17p deletion. Please look to this blog and our clinical trials page for further developments regarding the use of ibrutinib in patients with CLL.