Phase 2 Hyper-CVAD/Rituximab for Untreated Mantle Cell Lymphoma
Phase II Pilot Study of Hyper-CVAD Plus Rituximab for Previously Untreated Mantle Cell Lymphoma
1 other identifier
interventional
22
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jun 2000
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
December 19, 2007
CompletedFirst Posted
Study publicly available on registry
December 28, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedResults Posted
Study results publicly available
July 21, 2014
CompletedDecember 13, 2019
June 1, 2019
6 years
December 19, 2007
December 2, 2011
December 11, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
Median follow up of 37 months
Interventions
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 Criteria
You may qualify if:
- Untreated mantle cell lymphoma
You may not qualify if:
- Pregnant or breast feeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UWCCC
Madison, Wisconsin, 53792, United States
Related Publications (1)
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.
PMID: 16766582RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Brad S Kahl, MD
- Organization
- University of Wisconsin
Study Officials
- PRINCIPAL INVESTIGATOR
Brad S Kahl, MD
University of Wisconsin, Madison
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2007
First Posted
December 28, 2007
Study Start
June 1, 2000
Primary Completion
June 1, 2006
Study Completion
March 1, 2010
Last Updated
December 13, 2019
Results First Posted
July 21, 2014
Record last verified: 2019-06