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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase II Pilot Study of Hyper-CVAD Plus Rituximab for Previously Untreated Mantle Cell Lymphoma

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 Summary: 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
Sponsor: University of Wisconsin, Madison

Current Primary Outcome: Complete Response Rate to Induction Therapy [ Time Frame: 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).


Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Wisconsin, Madison

Dates:
Date Received: December 19, 2007
Date Started: June 2000
Date Completion:
Last Updated: June 25, 2014
Last Verified: June 2014