Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, Mantle-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphosarcoma

Mantle Cell Lymphoma

Antineoplastic Agents

All Drugs and Chemicals

Analgesics

Antirheumatic Agents

Gemcitabine

Mitoxantrone

Rituximab

Antineoplastic Agents, Immunological

Immunologic Factors

Antimetabolites

Enzyme Inhibitors

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.

gemcitabine

Novantrone 10 mg/m2on Day 1. The order of administration will be:

Gemzar--\>Novantrone--\>Rituxan.

mitoxantrone

Rituxan 375 mg/m2 on Day 1. The order of administration will be:

Gemzar--\>Novantrone--\>Rituxan.

rituximab

Lawrence Garbo, MD

To determine the efficacy (response rate) produced by the combination of Gemzar, Novantrone, and Rituxan in relapsed or refractory MCL

Ph2 Gem/Nov/Rituxan Rel/Ref MantleCell

A Phase II Study of Gemzar, Novantrone and Rituxan in Relapsed or Refractory Mantle Cell Lymphoma (MCL) (B9E-US-X436)

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.

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.

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.

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.

Eli Lilly and Company

US Oncology Research

Dr. Lawrence Garbo, Principal Investigator

For treated patients only, assessed at each treatment visit.

Gemzar, Novantrone, and Rituxan in relapsed or refractory mantle cell lymphoma (MCL)

Gemzar + Novantrone + Rituxan

Age, Continuous

Sex: Female, Male

Caucasian

Race/Ethnicity, Customized

United States

Region of Enrollment

Dr. Lawrence E. Garbo

Objective Response Rate (CR + PR)

For patients who achieve a major objective response (CR or PR) the time to response will be assessed as the date of registration to the date of response.

Spots Global Cancer Trial Database for relapsed or refractory mantle cell lymphoma (mcl)