The study hypothesis is that the addition of zevalin radioimmunotherapy to the conditioning regimen given prior to BEAM high-dose chemotherapy and autologous stem cell transplantation in patients with aggressive lymphoma will reduced disease recurrence rate and improve overall and disease-free survival.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
0.4 mCi/kg
Mayo Clinic Arizona
Scottsdale, Arizona, United States
City of Hope National Medical Center
Duarte, California, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
Moffitt Cancer Center
Tampa, Florida, United States
Overall Survival
actuarial 2 year survival
Time frame: 2 years after transplantation
Progression-free Survival
actuarial 2-year PFS
Time frame: 2 years after transplantation
Clinical Response
complete response (CR) and partial response (PR) proportion at day 100,
Time frame: 100 days after transplantation
Hematopoietic Recovery
time to hematopoietic recovery
Time frame: 100 days after transplantation
Grade III Toxicity
incidence of infection, grade III-IV toxicities, treatment-related mortality
Time frame: 100 days after transplantation
Secondary Malignancies
incidence of myelodysplastic syndrome (MDS), and secondary acute myelogenous leukemia (AML).
Time frame: 5 years after transplantation
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