To determine the efficacy (response rate) produced by the combination of Gemzar, Novantrone, and Rituxan in relapsed or refractory MCL
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
900 mg/m2 on Days 1 and 8 of each 21-day cycle The order of administration will be: Gemzar--\>Novantrone--\>Rituxan.
Novantrone 10 mg/m2on Day 1. The order of administration will be: Gemzar--\>Novantrone--\>Rituxan.
Rituxan 375 mg/m2 on Day 1. The order of administration will be: Gemzar--\>Novantrone--\>Rituxan.
Objective Response Rate (CR + PR)
Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.
Time frame: 2 years
Duration of Response
The duration of response is measured from the time measurement criteria are first met for CR/PR until the first date that recurrent or progressive disease is objectively documented. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.
Time frame: From date of randomization until the date of first documented progression or the date of death from any cause, whichever came first, assessed up to 33 months.
Overall Survival (OS) Rate at 1 Year
OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.
Time frame: 1 year.
Progression-free Survival Rate at 1 Year.
PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date.
Time frame: 1 year.
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