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.

Ibrutinib Granted Third Breakthrough Status for Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL)

On April 8, the FDA granted a third Breakthrough Therapy Designation for the investigational agent ibrutinib. Previously, receiving breakthrough status for the treatment of patients with Waldenström’s macroglobulinemia and mantle cell lymphoma, the drug has now achieved breakthrough status as a monotherapy for the treatment of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) in patients with deletion of the short arm of chromosome 17 (deletion 17p). This is an especially important development as CLL and SLL affected carriers of the deletion of chromosome 17 mutation are prone to poor prognoses, often due to their poor responses to chemoimmunotherapy.

Ibrutinib, an oral drug designed to specifically target an enzyme called Bruton’s tyrosine kinase (BTK), has demonstrated promising activity in multiple phase 1 and 2 clinical trials performed at Weill Cornell Medical College and around the world. As one of the leading institutions in the study of ibrutinib since its first testing 3 years ago, Weill Cornell is uniquely positioned in its experience with ibrutinib.

Currently, there are ongoing ibrutinib clinical trials at the Weill Cornell Lymphoma Program open to patients with CLL and SLL. Additional clinical trials for Waldenström’s macroglobulinemia and mantle cell lymphoma with ibrutinib are ongoing.

Please stay updated with our clinical trials listing for forthcoming trials involving ibrutinib and the Cornell Lymphoma Program website for further clinical research updates.