Phase II Pilot Study of Hyper-CVAD Plus Rituximab for Previously Untreated Mantle Cell Lymphoma
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- Complete Response Rate to Induction Therapy
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Untreated mantle cell lymphoma
Exclusion Criteria
- •Pregnant or breast feeding
Outcomes
Primary Outcomes
Complete Response Rate to Induction Therapy
Time Frame: Median follow up of 37 months
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 Outcomes
No secondary outcomes reported