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

Mantle Cell Lymphoma Clinical Trial

Official title:

Phase II Pilot Study of Hyper-CVAD Plus Rituximab for Previously Untreated Mantle Cell Lymphoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00581854
• Other study ID #: HO00401
• Status: Completed
• Phase: Phase 2
• Start date: June 2000
• Est. completion date: March 2010

Study information

• Verified date: June 2019
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: March 2010
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Untreated mantle cell lymphoma

Exclusion Criteria:

• Pregnant or breast feeding

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Mantle-Cell
• Mantle Cell Lymphoma

Intervention

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

Locations

Country	Name	City	State
United States	UWCCC	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

References & 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 mantl — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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