A Phase III Study of Ofatumumab versus Rituximab Salvage Chemoimmunotherapy Followed by Autologous Stem Cell Transplant in Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Protocol
11-079
Full Title
Ofatumumab Versus Rituximab Salvage Chemoimmunotherapy Followed by ASCT in Relapsed or Refractory DLBCL
Phase
III
Disease Status
Relapsed/Refractory
Purpose

The standard treatment for diffuse large B-cell lymphoma (DLBCL) or grade 3b follicular lymphoma that has relapsed after first treatment is rituximab combined with chemotherapy. Patients who respond well have their own stem cells collected and then re-infused after additional high-dose chemotherapy. However, rituximab improves the effectiveness of chemotherapy in only a small percentage of patients.

The purpose of this study is to see if giving the drug ofatumumab in place of rituximab in this treatment regimen is more effective than rituximab. Patients will receive either ofatumumab or rituximab, combined with standard chemotherapy, but not both. Patients in whom treatment works to control their lymphoma with then be treated with standard high-dose chemotherapy with transplantation of their own stem cells. This regimen will be assessed in patients with DLBCL or grade 3b follicular lymphoma that has returned or progressed despite prior treatment.

Ofatumumab is approved for treating chronic lymphocytic leukemia and has been assessed in non-Hodgkin¿s lymphoma, but its use 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 a confirmed diagnosis of CD20-positive DLBCL or grade 3b follicular lymphoma that has progressed or returned despite prior therapy with rituximab plus chemotherapy.
  • At least 2 weeks must have passed since completion of prior treatment and entry into the study.
  • Patients must be able to be ambulatory for more than half of their normal waking hours.
  • Patients must be age 18 or older and felt to be appropriate candidates for aggressive chemotherapy.

For more information and to inquire about eligibility for this study, please contact Dr. Matthew Matasar at 212-639-8889.

Disease(s)
Lymphoma
Lymphoma: Non-Hodgkin's Lymphoma
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