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

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ClinicalTrials.gov Identifier: NCT00581854
Recruitment Status : Completed
First Posted : December 28, 2007
Results First Posted : July 21, 2014
Last Update Posted : July 21, 2014
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Mantle Cell Lymphoma Drug: modified Hyper-CVAD Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Pilot Study of Hyper-CVAD Plus Rituximab for Previously Untreated Mantle Cell Lymphoma
Study Start Date : June 2000
Primary Completion Date : June 2006
Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab
U.S. FDA Resources


Intervention Details:
    Drug: modified Hyper-CVAD
    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


Primary Outcome Measures :
  1. 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Untreated mantle cell lymphoma

Exclusion Criteria:

  • Pregnant or breast feeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00581854


Locations
United States, Wisconsin
UWCCC
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Brad S Kahl, MD University of Wisconsin, Madison

Publications:
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00581854     History of Changes
Other Study ID Numbers: HO00401
First Posted: December 28, 2007    Key Record Dates
Results First Posted: July 21, 2014
Last Update Posted: July 21, 2014
Last Verified: June 2014

Keywords provided by University of Wisconsin, Madison:
untreated mantle cell lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Rituximab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents