Clinical trial · Interventional
Phase II Study of VcR-CVAD With Rituximab Consolidation and Maintenance for Untreated Mantle Cell Lymphoma
NCT00581776CI-TRIAL-00042351completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mantle Cell Lymphoma | Mantle Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bortezomib | Drug | Bortezomib | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
| Vincristine | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- VCR-CVAD with rituximab maintenance
- description
- Induction chemotherapy with Bortezomib, cyclophosphamide, rituximab, vincristine, doxorubicin, and dexamethasone. Subjects will receive 6 cycles of induction chemotherapy, of 21 days each. After completing induction, subjects will receive rituximab consolidation (4 weeks), and then rituximab maintenance therapy for up to 5 years.
- interventionNames
- Drug: Bortezomib
- Drug: Rituximab
- Drug: Cyclophosphamide
- Drug: Doxorubicin
- Drug: Vincristine
- Drug: Dexamethasone
Primary outcomes (2)
- measure
- Overall Response Rate (ORR) at the Completion of Induction Chemotherapy, Which is the Percent of Complete Responses (CR) Plus Percent of Partial Responses (PR).
- timeFrame
- At completion of induction therapy (21 weeks)
- description
- Patients were considered evaluable for response if they completed at least 2 cycles of therapy and had undergone an initial response evaluation, or had disease progression after 1 cycle of therapy. 1999 International Working Group criteria defines a CR as patients with complete disappearance of disease, or regression of all lymph nodes to 1.5 cm in greatest diameter or less. Partial Response indicates patients responded to treatment with a reduction in the amount of tumor (50 percent or more). Overall response rate is the percent of complete responses plus the percent of partial responses.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.