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

Primary Purpose

Mantle Cell Lymphoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
modified Hyper-CVAD
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mantle Cell Lymphoma focused on measuring untreated mantle cell lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Untreated mantle cell lymphoma

Exclusion Criteria:

  • Pregnant or breast feeding

Sites / Locations

  • UWCCC

Outcomes

Primary Outcome Measures

Complete Response Rate to Induction Therapy
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).

Secondary Outcome Measures

Full Information

First Posted
December 19, 2007
Last Updated
December 11, 2019
Sponsor
University of Wisconsin, Madison
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1. Study Identification

Unique Protocol Identification Number
NCT00581854
Brief Title
Phase 2 Hyper-CVAD/Rituximab for Untreated Mantle Cell Lymphoma
Official Title
Phase II Pilot Study of Hyper-CVAD Plus Rituximab for Previously Untreated Mantle Cell Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
June 2000 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mantle Cell Lymphoma
Keywords
untreated mantle cell lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
modified Hyper-CVAD
Intervention 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
Primary Outcome Measure Information:
Title
Complete Response Rate to Induction Therapy
Description
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).
Time Frame
Median follow up of 37 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Untreated mantle cell lymphoma Exclusion Criteria: Pregnant or breast feeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brad S Kahl, MD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
UWCCC
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16766582
Citation
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. doi: 10.1093/annonc/mdl127. Epub 2006 Jun 9.
Results Reference
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Phase 2 Hyper-CVAD/Rituximab for Untreated Mantle Cell Lymphoma

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