Ph2 Gem/Nov/Rituxan Rel/Ref MantleCell
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|ClinicalTrials.gov Identifier: NCT00656084|
Recruitment Status : Completed
First Posted : April 10, 2008
Results First Posted : November 3, 2016
Last Update Posted : November 3, 2016
|Condition or disease||Intervention/treatment||Phase|
|Relapsed or Refractory Mantle Cell Lymphoma (MCL)||Drug: gemcitabine Drug: mitoxantrone Drug: rituximab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Gemzar, Novantrone and Rituxan in Relapsed or Refractory Mantle Cell Lymphoma (MCL) (B9E-US-X436)|
|Study Start Date :||December 2004|
|Actual Primary Completion Date :||January 2007|
|Actual Study Completion Date :||January 2008|
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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00656084
|Principal Investigator:||Lawrence Garbo, MD||US Oncology Research|