Phase II Study of VcR-CVAD With Rituximab Consolidation and Maintenance for Untreated Mantle Cell Lymphoma

University of Wisconsin (UW)

Status and phase: Completed; Phase 2

Conditions: Mantle Cell Lymphoma

Treatments: Drug: Vincristine; Drug: Rituximab; Drug: Dexamethasone; Drug: Doxorubicin; Drug: Bortezomib; Drug: Cyclophosphamide

Study type: Interventional

Funder types: Other

Identifiers

NCT00581776

A534260 (Other Identifier)

HO05401

SMPH\MEDICINE\HEM-ONC (Other Identifier)

2011-0807 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

VCR-CVAD with rituximab maintenance

Experimental group

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.

Treatment:

Drug: Dexamethasone

Drug: Cyclophosphamide

Drug: Bortezomib

Drug: Vincristine

Drug: Doxorubicin

Drug: Rituximab