A Phase Ib Study of Urelumab Given with Rituximab in Patients with Recurrent or Persistent Non-Hodgkin Lymphoma or Chronic Lymphocytic Leukemia

Protocol
13-252
Full Title
A Phase 1b, Open-label, Multicenter Study of Urelumab (BMS-663513) in Combination with Rituximab in Subjects with Relapsed/Refractory B-Cell Malignancies
Phase
I
Disease Status
Relapsed/Refractory
Purpose

Rituximab is a medication commonly used to treat B-cell cancers such as non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL). However, the cancer often comes back. In this study, researchers want to find the highest dose of an investigational drug called urelumab (BMS-663513) that can be given safely with rituximab in patients with B-cell NHL or CLL.

Urelumab is an antibody which recognizes a protein on immune cells called CD137. By binding to CD137, urelumab may stimulate patients’ immune cells to attack their cancer cells. The action of urelumab can help overcome resistance that patients’ cancer cells may have developed to rituximab. Both drugs are 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 B-cell NHL or CLL that is positive for the CD20 protein (the target of rituximab) and has returned or persisted despite at least one prior regimen of therapy.
  • Prior therapy with rituximab is permitted.
  • At least 4 weeks must pass between completion of prior therapy 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 open to patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Andrew Zelenetz at 212-639-2656.

Disease(s)
Leukemia: Chronic Lymphocytic Leukemia
Lymphoma: Non-Hodgkin's Lymphoma
Locations