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

This study has been completed.

Sponsor:

Information provided by:

University of Wisconsin, Madison

ClinicalTrials.gov Identifier:

NCT00581854

First received: December 19, 2007

Last updated: December 9, 2010

Last verified: December 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	December 19, 2007
Last Updated Date	December 9, 2010
Start Date ^ICMJE	June 2000
Primary Completion Date	June 2006 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 23, 2010)	Complete Response Rate to Induction Therapy [ Time Frame: 10/31/2004 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00581854 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Phase 2 Hyper-CVAD/Rituximab for Untreated Mantle Cell Lymphoma
Official Title ^ICMJE	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 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 ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Mantle Cell Lymphoma
Intervention ^ICMJE	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
Study Arm (s)	Not Provided
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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	22
Completion Date	March 2010
Primary Completion Date	June 2006 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Untreated mantle cell lymphoma Exclusion Criteria: Pregnant or breast feeding
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00581854
Other Study ID Numbers ^ICMJE	HO00401
Has Data Monitoring Committee	Yes
Responsible Party	Brad Kahl MD, University of Wisconsin
Study Sponsor ^ICMJE	University of Wisconsin, Madison
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University of Wisconsin, Madison
Verification Date	December 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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