At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 16 enrolled
Drug / intervention
gemcitabine +2 moredrug
Likely dose
gemcitabine 900 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Study of Gemzar, Novantrone and Rituxan in Relapsed or Refractory Mantle Cell Lymphoma (MCL) (B9E-US-X436)
In Brief
A Phase 2 clinical trial evaluating gemcitabine, mitoxantrone, and 1 other intervention for Relapsed or Refractory Mantle Cell Lymphoma (MCL). Completed, enrolled 16 participants.
Detailed Summary
To determine the efficacy (response rate) produced by the combination of Gemzar, Novantrone, and Rituxan in relapsed or refractory MCL
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
CollaboratorsEli Lilly and Company
Timeline
Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartDec 2004
Primary CompletionJan 2007
Study CompletionJan 2008
First PostedApr 2008
TodayJul 2026
First PostedApr 10, 2008
Enrollment StartDec 1, 2004
Primary CompletionJan 1, 2007
Study CompletionJan 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 18.2 years ago
Interventions
gemcitabinedrug
900 mg/m2 on Days 1 and 8 of each 21-day cycle The order of administration will be: Gemzar--\>Novantrone--\>Rituxan.
mitoxantronedrug
Novantrone 10 mg/m2on Day 1. The order of administration will be: Gemzar--\>Novantrone--\>Rituxan.
rituximabdrug
Rituxan 375 mg/m2 on Day 1. The order of administration will be: Gemzar--\>Novantrone--\>Rituxan.