A Phase IB Study of Buparlisib plus Ibrutinib in Patients with Non-Hodgkin Lymphoma

Full Title

Phase I Clinical Trial of Buparlisib and Ibrutinib in Mantle Cell Lymphoma, Follicular Lymphoma and Diffuse Large B Cell Lymphoma

Purpose

The purpose of this study is to determine the highest doses of buparlisib and ibrutinib that can be given safely in patients with mantle cell lymphoma (MCL), follicular lymphoma (FL), or diffuse large B-cell lymphoma (DLBCL) that has continued to grow or came back after prior therapy.

Ibrutinib is used to treat lymphoma and chronic lymphocytic leukemia. It works by blocking a protein inside lymphoma cells called Bruton's tyrosine kinase (BTK), which helps lymphoma cells to live and grow. It is taken orally (by mouth).

Buparlisib (BKM120) is an investigational drug that blocks a molecule called PI3 kinase, which appears to function abnormally in many cancers. It is also taken orally. The use of buparlisib with ibrutinib in this study is considered investigational.

Eligibility

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

  • Patients must have MCL, FL, or DLBCL that has continued to grow or came back despite previous treatment.
  • At least 2 weeks must pass between completion of prior chemotherapy or radiation therapy and 4 weeks since any major surgery and entry into the study.
  • Patients may not have previously received inhibitors of BTK or PI3 kinase.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Anas Younes at 212-639-5059 or Amy Copeland at 212-639-6104.

Protocol

16-009

Phase

I

Investigator

Co-Investigators