Ph2 Gem/Nov/Rituxan Rel/Ref MantleCell
Relapsed or Refractory Mantle Cell Lymphoma (MCL)
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Gemzar, Novantrone and Rituxan in Relapsed or Refractory Mantle Cell Lymphoma (MCL) (B9E-US-X436)|
- Objective Response Rate (CR + PR) [ Time Frame: 2 years ]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.
- Duration of Response [ 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. ]
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.
- Overall Survival (OS) Rate at 1 Year [ Time Frame: 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.
- Progression-free Survival Rate at 1 Year. [ Time Frame: 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.
|Study Start Date:||December 2004|
|Study Completion Date:||January 2008|
|Primary Completion Date:||January 2007 (Final data collection date for primary outcome measure)|
Experimental: Experimental arm
Patients will be treated a maximum of 8 cycles or until the patient has evidence of a response, progressive disease, or until intolerable toxicity develops. Patients with a complete response will receive an additional 2 cycles of treatment (not to exceed 8 cycles). Drug order is gemcitabine, mitoxantrone, and rituximab.
900 mg/m2 on Days 1 and 8 of each 21-day cycle The order of administration will be: Gemzar-->Novantrone-->Rituxan.
Other Name: GemzarDrug: mitoxantrone
Novantrone 10 mg/m2on Day 1. The order of administration will be:
Other Name: NovantroneDrug: rituximab
Rituxan 375 mg/m2 on Day 1. The order of administration will be:
Other Name: Rituxan
Please refer to this study by its ClinicalTrials.gov identifier: NCT00656084
|Principal Investigator:||Lawrence Garbo, MD||US Oncology Research|