A Phase I/II Study of Copanlisib and Ibrutinib in Mantle Cell Lymphoma

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Full Title

Phase I/II Clinical Trial of Copanlisib and Ibrutinib in Mantle Cell Lymphoma

Purpose

This study is evaluating the safety and effectiveness of combining the drugs copanlisib and ibrutinib in patients with previously treated mantle cell lymphoma (MCL) that persists or has gotten worse. Ibrutinib blocks a protein called Bruton’s tyrosine kinase (BTK) that may help lymphoma cells multiply and survive. Copanlisib blocks an enzyme called PI3K, which plays an important role in the growth and spread of cancer. Earlier research suggests that the combination of copanlisib and ibrutinib will prevent cancer cells from growing, and may cause them to die.

Ibrutinib is already used to treat previously treated MCL. Copanlisib is used to treat follicular cell lymphoma; its use against MCL and in combination with ibrutinib is considered investigational. Ibrutinib is taken orally (by mouth) and copanlisib is given intravenously (by vein).

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 or has gotten worse following prior treatment.
  • Previous treatment with BTK and PI3K inhibitors is permitted.
  • At least 2 weeks must pass since the completion of previous chemotherapy or radiation therapy and entry into the study.
  • 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 about this study and to inquire about eligibility, please contact Dr. Connie Batlevi at 212-639-8081.

Protocol

18-450

Phase

I/II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators