A Phase II Trial of Rituxan and BEAM High-Dose Chemotherapy and Autologous Peripheral Blood Progenitor Transplant for Lymphoma
OBJECTIVES: I. Determine the complete and partial response rate of patients with relapsed or
refractory B-cell non-Hodgkin's lymphoma treated with rituximab and high-dose carmustine,
etoposide, cytarabine and melphalan followed by autologous bone marrow or peripheral blood
stem cell transplantation. II. Determine the toxicity profile of this regimen in these
patients. III. Compare the levels of soluble CD20 antigen and rituximab blood levels with
patient outcomes in this patient population.
OUTLINE: Patients receive two doses of rituximab IV over 3-4 hours 1 week apart. Stem cells
from the peripheral blood or bone marrow are collected at least 1 week after the second dose
of rituximab. Following stem cell collection, patients receive a third dose of rituximab IV
as above between days -10 and -6. Patients then receive high-dose chemotherapy consisting of
carmustine IV on day -6, etoposide IV twice daily and cytarabine IV on days -5 to -2, and
melphalan IV on day -1. On day 0 patients undergo autologous bone marrow or peripheral blood
stem cell transplantation. After transplantation, patients receive a fourth dose of
rituximab as above at approximately day 30, and then weekly over 4 weeks at approximately 6
months in the absence of disease progression or unacceptable toxicity. Patients are followed
at 1 year and then annually thereafter.
PROJECTED ACCRUAL: A total of 23-40 patients will be accrued for this study within 3 years.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary endpoint for this study is 100 day (complete + partial) response rate
Julie M. Vose, MD
University of Nebraska
United States: Federal Government
|University of Nebraska Medical Center||Omaha, Nebraska 68198-3330|