NCT00656084

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: US Oncology Research · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2004-12-01
• Primary completion: 2007-01-01
• Completion: 2008-01-01
• First posted: 2008-04-10
• Last updated: 2016-11-03
• Results posted: 2016-11-03