Phase 2 Hyper-CVAD/Rituximab for Untreated Mantle Cell Lymphoma

Phase 2

Completed

• Conditions: Mantle Cell Lymphoma

• Registration Number: NCT00581854
• Lead Sponsor: University of Wisconsin, Madison

Brief Summary

rituximab and modified (hyperCVAD) administered every 28 days for 4-6 cycles followed by rituximab maintenance therapy consisting of four weekly doses every six months for two years

Detailed Description

rituximab and modified hyperfractionated cyclophosphamide, vincristine doxorubicin, dexamethasone (hyperCVAD) administered every 28 days for 4-6 cycles followed by rituximab maintenance therapy consisting of four weekly doses every six months for two years

Study Timeline

• Study Start: 2000-06
• Primary Completion: 2006-06
• Study First Submitted: 2007-12-19
• Study First Submitted QC: 2007-12-27
• Study First Posted: 2007-12-28
• Study Completion: 2010-03
• Results First Submitted: 2011-12-02
• Results First Submitted QC: 2014-06-25
• Results First Posted: 2014-07-21
• Status Verified: 2019-06
• Last Update Submitted: 2019-12-11
• Last Update Posted: 2019-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• Untreated mantle cell lymphoma

Exclusion Criteria

• Pregnant or breast feeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Complete Response Rate to Induction Therapy	Median follow up of 37 months	Outcome is the % of subjects who achieved a Complete Response (CR) or Complete Response Unconfirmed (CRu) after induction therapy, following the Cheson et al criteria for standardized response criteria (1999).

Trial Locations

Locations (1)

UWCCC; 🇺🇸 Madison, Wisconsin, United States