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Ph2 Gem/Nov/Rituxan Rel/Ref MantleCell

NCT00656084 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2016-11-03

Study results available
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Summary

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

Conditions

  • Relapsed or Refractory Mantle Cell Lymphoma (MCL)

Interventions

DRUG

gemcitabine

900 mg/m2 on Days 1 and 8 of each 21-day cycle The order of administration will be: Gemzar--\>Novantrone--\>Rituxan.

DRUG

mitoxantrone

Novantrone 10 mg/m2on Day 1. The order of administration will be: Gemzar--\>Novantrone--\>Rituxan.

DRUG

rituximab

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

Sponsors & Collaborators

Principal Investigators

  • Lawrence Garbo, MD · US Oncology Research

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-12-31
Primary Completion
2007-01-31
Completion
2008-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00656084 on ClinicalTrials.gov