Overview

This trial is active, not recruiting.

Condition mantle cell lymphoma
Treatments bortezomib, rituximab, cyclophosphamide, doxorubicin, vincristine, dexamethasone
Phase phase 2
Targets CD20, proteasome
Sponsor University of Wisconsin, Madison
Start date May 2005
End date November 2008
Trial size 30 participants
Trial identifier NCT00581776, HO05401

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
bortezomib Velcade, PS-341
Administered by IV at 1.3 mg/m2 days 1 and 4 of each 21 day cycle.
rituximab Rituxan
Administered by IV 375 mg/m2 IV day 1 of each cycle during induction chemotherapy, then weekly for four weeks during consolidation therapy; and then once every 12 weeks for up to 5 years (or until disease progression).
cyclophosphamide cytoxan
Administered by IV at 300 mg/m2, 6 doses spaced 12 hours apart on days 1-3 of each cycle, to start after completion of rituximab infusion
doxorubicin
Given as a continuous infusion, 50 mg/m2 over 48 hours days 1-2 of each cycle, to start after completion of rituximab infusion.
vincristine
1 mg administered by IV on day 3 of each cycle.
dexamethasone
40 mg orally on days 1-4 of each cycle.

Primary Outcomes

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).
time frame: At completion of induction therapy (21 weeks)
Complete Response Rate (CR) at the End of Induction Chemotherapy
time frame: at 21 weeks

Secondary Outcomes

Measure
3 Year Progression Free Survival
time frame: 36 months
3 Year Overall Survival (OS)
time frame: 36 months

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Phase II Study of VcR-CVAD With Rituximab Consolidation and Maintenance for Untreated Mantle Cell Lymphoma
Principal investigator Brad S Kahl, MD
Description Primary objective is to estimate the overall response rate (ORR) and the complete response rate (CRR) to the VcR CVAD regimen (response rate at completion of induction). 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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by University of Wisconsin, Madison.