Ibrutinib is Effective Therapy for Patients with Previously Treated Mantle Cell Lymphoma

On June 20, 2013, the exciting results of a phase 2 clinical trial of ibrutinib in patients with previously treated mantle cell lymphoma (MCL) were published in the New England Journal of Medicine. Ibrutinib is an oral inhibitor of Bruton’s Tyrosine Kinase (BTK), an enzyme that plays a critical role in the survival and growth of some lymphomas, including MCL, CLL/SLL, follicular lymphoma, DLBCL, and Waldenstrom’s macroglobulinemia.

In this trial, 111 patients with MCL received oral ibrutinib at a dose of 560 mg daily. Despite a high number of prior therapies, 68% of patients experienced a significant response to ibrutinib, including 21% of patients experiencing a complete response. The estimated average response duration was almost 18 months. Overall, the treatment was well tolerated. The study authors concluded that ibrutinib is highly effective in treating relapsed and refractory MCL, achieving responses comparable to intensive chemotherapy regimens with less toxicity. Weill Cornell’s Dr. Peter Martin, one of the study’s lead authors, commented, “It has been tremendously gratifying to be able to offer ibrutinib to our patients with mantle cell lymphoma. We are all working hard so that this drug can be made available to all patients in the near future.”

The Lymphoma Program at Weill Cornell will be participating in an early access trial that will help provide ibrutinib to patients with MCL pending its official FDA approval.  Look to this space for further updates.

New Clinical Trial: Ibrutinib in Refractory Follicular Lymphoma

The Weill Cornell Lymphoma Program has recently opened a clinical trial evaluating ibrutinib in men and women with refractory follicular lymphoma. The study sponsor is Janssen Pharmaceuticals, and the principal investigator at Weill Cornell is Dr. Peter Martin. For more information about the study, please call Amelyn Rodriguez, RN at (212) 746-1362 or e-mail Amelyn at amr2017@med.cornell.edu.

Key Eligibility
  • Age 18 and older
  • Refractory follicular lymphoma
  • Previously treated with at least 2 prior lines of therapy
  • Did not respond to last prior therapy
  • Detailed eligibility reviewed when you contact the study team
Study Details

The purpose of the study is to evaluate the response to treatment with the experimental drug ibrutinib, also called PCI-32765. Ibrutinib is an oral drug that inhibits the enzyme Bruton’s Tyrosine Kinase (BTK), decreasing the ability of lymphoma cells to grow and survive.

Treatment Plan

All study participants will receive ibrutinib; there is no placebo. Participants will take 4 capsules by mouth once every day. Participants will continue taking ibrutinib as long as they are responding to treatment and not experiencing unacceptable side effects.

Click here to view all current lymphoma trials at Weill Cornell Medical College.

New Clinical Trial: Ibrutinib in Relapsed/Refractory CLL/SLL with 17p Deletion

Update: this study is closed to enrollment. 

The Weill Cornell Lymphoma Program is now recruiting men and women with relapsed or refractory Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) with 17p deletion for a new clinical trial evaluating the experimental drug ibrutinib. The study sponsor is Pharmacyclics, and the principal investigator at Weill Cornell is Dr. Richard Furman. 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
  • Men and women age 18 and older
  • Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) with 17p deletion
  • Relapsed or refractory disease after receiving at least one prior line line of systemic therapy which included at least two cycles of chemotherapy or immunotherapy for CLL/SLL
  • Detailed eligibility reviewed when you contact the study team
Study Details

Ibrutinib (also known as PCI-32765) is a type of drug called a kinase inhibitor; the drug blocks an enzyme that helps cancer cells live and grow. By blocking the enzyme, it is possible that ibrutinib will kill cancer cells or stop them from growing.

The purpose of the study is to determine whether ibrutinib is safe and effective in treating CLL/SLL with 17p deletion.

Treatment Plan

All study participants will receive ibrutinib; there is no placebo in this study. Participants will take 3 capsules by mouth once a day and continue on treatment as long as they are responding to therapy and not experiencing unacceptable side effects.