The purpose of this study is to evaluate the efficacy and safety of Zevalin compared with observation alone in participants who are in PET-negative complete remission after first-line R-CHOP or R-CHOP like therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
79
Zevalin administered intravenous infusion.
Y-90-Zevalin administered by intravenous infusion.
Rituximab administered by intravenous infusion.
In-111-Zevalin administered by intravenously.
Cancer Treatment Services Arizona
Casa Grande, Arizona, United States
Sutter East Bay Hospitals
Berkeley, California, United States
City of Hope
Duarte, California, United States
Halifax Health Medical Center
Daytona Beach, Florida, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, United States
Overall Survival (OS) for Living Participants
OS was the time from randomization to death. In living participants, survival time was censored on the last date that participants were known to be alive. OS for living participant was calculated as (end of study date/last visit date - randomization date)+ 1/30.4375. Overall Survival was summarized separately for living participants as only few participants died in this study.
Time frame: From randomization till death or end of study, whichever occurs first (Up to approximately 2.5 years)
Overall Survival for Death
OS was the time from randomization to death. OS for death calculated as (date of death - randomization date)+ 1/30.4375. Overall Survival was summarized separately for participants who were died as only few participants died in this study.
Time frame: From randomization till death or end of study, whichever occurs first (Up to approximately 2.5 years)
Progression-Free Survival (PFS)
PFS was defined as the time interval between the date of randomization and the date of relapse or death from any cause.
Time frame: From randomization till death or end of study, whichever occurs first (Up to approximately 2.5 years)
Overall Survival Rate at 24 Months
The OS rate at 24-month defined as the percentage of all randomized participants who died within 24 months of randomization.
Time frame: 24 Months
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Piedmont Hospital Cancer Center
Atlanta, Georgia, United States
St. Luke's Mountain States Tumor Institute (MSTI)
Boise, Idaho, United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
Decatur Memorial Hospital Cancer Care Specialists of Central Illinois
Decatur, Illinois, United States
...and 83 more locations