PH2 Hyper-CVAD/Rituximab for Untreated Mantle Cell Lymphoma - Full Text View

Sponsored by:	University of Wisconsin, Madison
Information provided by:	University of Wisconsin, Madison
ClinicalTrials.gov Identifier:	NCT00581854

Purpose

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

Condition	Intervention	Phase
Mantle Cell Lymphoma	Drug: modified Hyper-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 Piolot Study of Hyper-CVAD Plus Rituximab for Previously Untreated Mantle Cell Lymphoma

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

Primary Outcome Measures:

Complete Response Rate to Induction Therapy [ Designated as safety issue: No ]

Enrollment:	22
Study Start Date:	June 2000
Estimated Study Completion Date:	December 2009
Primary Completion Date:	June 2006 (Final data collection date for primary outcome measure)

Intervention Details:

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

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

Eligibility

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

Criteria

Inclusion Criteria:

Untreated mantle cell lymphoma

Exclusion Criteria:

Pregnant or breast feeding

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00581854

Locations

United States, Wisconsin
UWCCC
Madison, Wisconsin, United States, 53792

Sponsors and Collaborators

University of Wisconsin, Madison

More Information

Publications:

Kahl BS, Longo WL, Eickhoff JC, Zehnder J, Jones C, Blank J, McFarland T, Bottner W, Rezazedeh H, Werndli J, Bailey HH; Wisconsin Oncology Network. Maintenance rituximab following induction chemoimmunotherapy may prolong progression-free survival in mantle cell lymphoma: a pilot study from the Wisconsin Oncology Network. Ann Oncol. 2006 Sep;17(9):1418-23. Epub 2006 Jun 9.

Responsible Party:	University of Wisconsin ( Brad Kahl MD )
Study ID Numbers:	HO00401
Study First Received:	December 19, 2007
Last Updated:	March 26, 2009
ClinicalTrials.gov Identifier:	NCT00581854 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
Vincristine
Mantle Cell Lymphoma
Cyclophosphamide

Doxorubicin
Lymphatic Diseases
Hyperkinesis
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