Ph2 Gem/Nov/Rituxan Rel/Ref MantleCell

Conditions

• Relapsed or Refractory Mantle Cell Lymphoma (MCL)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• gemcitabine — DRUG
  900 mg/m2 on Days 1 and 8 of each 21-day cycle The order of administration will be: Gemzar--\>Novantrone--\>Rituxan.
• mitoxantrone — DRUG
  Novantrone 10 mg/m2on Day 1. The order of administration will be: Gemzar--\>Novantrone--\>Rituxan.
• rituximab — DRUG
  Rituxan 375 mg/m2 on Day 1. The order of administration will be: Gemzar--\>Novantrone--\>Rituxan.

Study Details

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

Key Dates

Start date

Dec 31, 2004

Status verified

Sep 2016

Primary completion

Jan 31, 2007

Completion

Jan 31, 2008

Study Design

Enrollment

16 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• 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.

Primary Outcome Measure

Objective Response Rate (CR + PR) [ Time Frame: 2 years ]