Phase II Study of VcR-CVAD With Rituximab Consolidation and Maintenance for Untreated Mantle Cell Lymphoma

This study is ongoing, but not recruiting participants.

First Received: December 19, 2007 Last Updated: March 26, 2009 History of Changes

Sponsored by:	University of Wisconsin, Madison
Information provided by:	University of Wisconsin, Madison
ClinicalTrials.gov Identifier:	NCT00581776

Purpose

Patients will receive Rituximab, Bortezomib, cyclophosphamide, Doxorubicin, Vincristine, Dexamethasone in three week intervals for 6 cycles; then rituximab consolidation (weekly x 4) , then one dose of rituximab every 12 weeks until 5 years or disease progression.

Condition	Intervention	Phase
Mantle Cell Lymphoma	Drug: VCR-CVAD	Phase II

MedlinePlus related topics: Lymphoma

Drug Information available for: Rituximab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase II Study of VcR-CVAD With Rituximab Consolidation and Maintenance for Untreated Mantle Cell Lymphoma

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:

CT scan [ Time Frame: every 2nd cycle ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	May 2005
Estimated Study Completion Date:	November 2013
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
VCR-CVAD with rituximab maintenance: Experimental	Drug: VCR-CVAD Rituximab, Bortezomib, cyclophosphamide, Doxorubicin, Vincristine, Dexamethasone

Detailed Description:

Primary objective is to estimate the overall response rate (ORR) and the complete response rate (CRR) to the VcR CVAD regimen (response rate at completion of induction). Patients will receive Rituximab, Bortezomib, cyclophosphamide, Doxorubicin, Vincristine, Dexamethasone in three week intervals for 6 cycles; then rituximab consolidation (weekly x 4) , then one dose of rituximab every 12 weeks until 5 years or disease progression.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically confirmed CD20+ mantle cell lymphoma, with measurable or evaluable disease, no prior chemo, immunotherapy or radiotherapy except for 1 cycle of CHOP-like chemotherapy.

Exclusion Criteria:

Patients with known CNS disease, known HIV infection, grade 2 or greater peripheral neuropathy, history of myocardial infarction in last 6 months, or patients who are Hep B Surface Antigen positive.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00581776

Locations

United States, Wisconsin
University Of Wisconsin Cancer Center
Madison, Wisconsin, United States, 53792

Sponsors and Collaborators

University of Wisconsin, Madison

Investigators

Principal Investigator:

Brad S Kahl, MD

University of Wisconsin, Madison

More Information

No publications provided

Responsible Party:	university fo Wisconsin ( brad Kahl MD )
Study ID Numbers:	HO05401
Study First Received:	December 19, 2007
Last Updated:	March 26, 2009
ClinicalTrials.gov Identifier:	NCT00581776 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:

Untreated Mantle Cell Lymphoma

Study placed in the following topic categories:

Dexamethasone
Immunoproliferative Disorders
Immunologic Factors
Rituximab
Lymphoma, Mantle-Cell
Bortezomib
Vincristine
Mantle Cell Lymphoma

Cyclophosphamide
Doxorubicin
Lymphatic Diseases
Antirheumatic Agents
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma
Dexamethasone acetate

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Immunologic Factors
Antineoplastic Agents
Rituximab
Lymphoma, Mantle-Cell
Physiological Effects of Drugs

Pharmacologic Actions
Lymphatic Diseases
Neoplasms
Therapeutic Uses
Antirheumatic Agents
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma

ClinicalTrials.gov processed this record on May 07, 2009