A Phase III Study of Ibritumomab Tiuxetan versus Observation in Older Patients with Diffuse Large B-Cell Lymphoma in Remission following R-CHOP

Protocol
12-061
Full Title
A Phase 3, Open-label, Multicenter, Randomized Study of Sequential Zevalin (ibritumomab tiuxetan) versus Observation in Patients at Least 60 Years of Age with Newly Diagnosed Diffuse Large B-cell Lymphoma in PET-negative Complete Remission After R-CHOP or R-CHOP-like Therapy (ZEAL)
Phase
III
Disease Status
Newly Diagnosed
Purpose

Ibritumomab tiuxetan is an approved therapy for non-Hodgkin lymphoma (NHL), including B-cell lymphomas. It is an antibody that carries a radioactive substance directly to NHL cells, where the radiation can kill the cancer cells.

In this study, researchers are assessing the use of ibritumomab as potential consolidation therapy in patients age 60 and older who have achieved remission of their diffuse B-cell lymphoma (DLBCL) after receiving standard chemotherapy. Patients will be randomly assigned to receive ibritumomab or observation (no treatment unless the NHL returns), and researchers will follow and compare the two groups.

Eligibility

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

  • Patients must have CD20-positive DLBCL that is in remission after receiving R-CHOP therapy or treatment similar to R-CHOP.
  • Patients must be age 60 or older.
  • Patients may not have had prior radiation therapy or radioimmunotherapy for their DLBCL.
  • Patients must be able to be ambulatory for more than half of their normal waking hours.

For more information about this study and to inquire about eligibility, please contact Dr. Paul A. Hamlin at 212-639-6143.

Disease(s)
Lymphoma
Lymphoma: Non-Hodgkin's Lymphoma
Locations
Related Diseases