Conditions: Relapsed or Refractory Mantle Cell Lymphoma (MCL)
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 16
Healthy volunteers: no

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

Detailed description:

Arms:
arm 1: 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.

Interventions: intervention 1: gemcitabine intervention 2: mitoxantrone intervention 3: rituximab
Intervention descriptions: intervention 1: 900 mg/m2 on Days 1 and 8 of each 21-day cycle The order of administration will be: Gemzar--\>Novantrone--\>Rituxan. intervention 2: Novantrone 10 mg/m2on Day 1. The order of administration will be:

Gemzar--\>Novantrone--\>Rituxan. intervention 3: Rituxan 375 mg/m2 on Day 1. The order of administration will be:

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

Protocol document: