Phase 2
Completed N=30
Phase II Study of VcR-CVAD With Rituximab Consolidation and Maintenance for Untreated Mantle Cell Lymphoma
Source: ClinicalTrials.gov NCT00581776 ↗Enrolled (actual)
30
Serious AEs
60.0%
Results posted
Feb 2011
Primary outcomePrimary: Overall Response Rate (ORR) at the Completion of Induction Chemotherapy, Which is the Percent of Complete Responses (CR) Plus Percent of Partial Responses (PR). — 90 Percent of participants
Summary
Patients will receive Rituximab, Bortezomib, cyclophosphamide, Doxorubicin, Vincristine, Dexamethasone in three week intervals for 6 cycles; then rituximab consolidation (weekly x 4) , then one dose of rituximab every 12 weeks until 5 years or disease progression.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response Rate (ORR) at the Completion of Induction Chemotherapy, Which is the Percent of Complete Responses (CR) Plus Percent of Partial Responses (PR). |
90 | — |
| PRIMARY Complete Response Rate (CR) at the End of Induction Chemotherapy |
77 | — |
| SECONDARY 3 Year Progression Free Survival |
63 | — |
| SECONDARY 3 Year Overall Survival (OS) |
86 | — |
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed CD20+ mantle cell lymphoma, with measurable or evaluable disease, no prior chemotherapy, immunotherapy or radiotherapy except for 1 cycle of CHOP-like chemotherapy.
Exclusion Criteria
- Patients with known CNS disease, known HIV infection, grade 2 or greater peripheral neuropathy, history of myocardial infarction in last 6 months, or patients who are Hepatitis B Surface Antigen positive.
Data sourced from ClinicalTrials.gov (NCT00581776). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.