Category: Clinical Trials

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.

Zydelig Approved by FDA for Patients with CLL, FL, & SLL

Earlier this afternoon the FDA announced the approval of Zydelig (idelalisib) for patients with relapsed chronic lymphocytic leukemia (CLL). Accelerated approval was also granted for the use of  Zydelig in patients with relapsed follicular B-cell non-Hodgkin lymphoma (FL) and relapsed small lymphocytic lymphoma (SLL). According to the FDA press release:

“Zydelig’s safety and effectiveness to treat relapsed CLL were established in a clinical trial of 220 participants who were randomly assigned to receive Zydelig and Rituxan or placebo and Rituxan. The trial was stopped for efficacy following the first pre-specified interim analysis point, which showed participants treated with Zydelig and Rituxan lived 10.7 months without their disease progressing (progression-free survival) compared to about 5.5 months for participants treated with placebo and Rituxan. Results from a second interim analysis continued to show a statistically significant improvement for Zydelig and Rituxan over placebo and Rituxan.”

…

“Zydelig’s safety and effectiveness to treat relapsed FL and relapsed SLL were established in a clinical trial with 123 participants with slow-growing (indolent) non-Hodgkin lymphomas. All participants were treated with Zydelig and were evaluated for complete or partial disappearance of their cancer after treatment (objective response rate, or ORR). Results showed 54 percent of participants with relapsed FL and 58 percent of participants with SLL experienced ORR.”

Commenting on this welcomed development Dr. Richard Furman said, “We are very excited to have idelalisib to add to our armentarium of agents that are now available for use and would like to thank all of the patients and their families who made this possible by participating in the clinical trials.” Look to this blog and our clinical trials page for further developments regarding the use of Zydelig in the treatment of CLL, FL, & SLL patients.