A Phase III Study of Ibrutinib Alone or with Venetoclax in Patients with Relapsed Mantle Cell Lymphoma

Full Title

PCYC-1143-CA: Phase 3 Study of Ibrutinib in Combination with Venetoclax in Subjects with Mantle Cell Lymphoma

Purpose

Ibrutinib is a drug approved to treat patients with relapsed mantle cell lymphoma (MCL). It works by blocking a protein inside cancer cells called Bruton’s tyrosine kinase (BTK), which helps cancer cells to live and grow. In this study, researchers want to see if adding the drug venetoclax to ibrutinib therapy is more effective than ibrutinib alone in patients with relapsed MCL.

Venetoclax is approved by the FDA to treat patients with a different type of B cell lymphoma called small lymphocytic lymphoma/leukemia. Although venetoclax can be active in patients with relapsed MCL, it is not approved for this indication. Venetoclax blocks a protein called Bcl-2, which helps cancer cells survive and resist the effects of anticancer treatments. By blocking Bcl-2, venetoclax could kill MCL cells and/or make them more vulnerable to the effects of other cancer treatments, such as ibrutinib.

Patients in this study will be randomly assigned to receive ibrutinib alone or with venetoclax. Both drugs are taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have MCL that persists despite at least one but no more than five prior regimens of therapy.
  • Patients may not have previously received ibrutinib or venetoclax.
  • At least 3 weeks must pass between the completion of previous treatments and entry into the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Anas Younes at 212-639-5059.

Protocol

18-157

Phase

III

Investigator

Co-Investigators