A Phase IB/IIA Study of Carfilzomib, Romidepsin, and Lenalidomide in Patients with Recurrent or Persistent Lymphoma

Full Title

A Phase Ib/IIa Study of Combination Therapy with Carfilzomib, Romidepsin, Lenalidomide in Patients with Relapsed or Refractory B- and T-cell Lymphomas

Purpose

Despite several available treatments for lymphoma, many patients experience a return (relapse) of their disease. Doctors are therefore seeking more effective therapies. The purpose of this study is to find the highest doses of three drugs — carfilzomib, romidepsin, and lenalidomide — that can be given safely together in patients with B-cell or T-cell lymphoma that has returned or continued to grow despite prior therapy. Researchers will also see how effective this therapy is.

Carfilzomib is a drug (called a proteasome inhibitor) that has been approved by the FDA to treat patients with relapsed multiple myeloma. Romidepsin is a drug approved to treat cutaneous T-cell lymphoma in patients who have already received prior therapy. Lenalidomide is approved for treating multiple myeloma, mantle cell lymphoma, and myelodysplastic syndromes. While these drugs are approved to treat cancer, their use together in this study is considered investigational.

Carfilzomib and romidepsin are given intravenously (by vein), while lenalidomide is 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 T-cell or B-cell lymphoma that has come back or continued to grow despite therapy.
  • At least 3 weeks must pass between completion of prior chemotherapy and entry into the study (2 weeks since radiation therapy, hormonal therapy, or major surgery).
  • 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. Steven M. Horwitz at 212-639-3045.

Protocol

14-179

Phase

I/II

Investigator

Co-Investigators