A Phase II Study of VcR-CVAD With Rituximab Maintenance for Untreated Mantle Cell Lymphoma
I. To evaluate the CR rate in patients with mantle cell lymphoma, who are treated with
I. To evaluate the overall response rate to VcR-CVAD. II. To evaluate the PFS and OS of
patients receiving maintenance rituximab after VcRCVAD induction.
III. To evaluate the PFS and OS of patients who receive autologous stem cell transplantation
after VcR-CVAD induction.
IV. To evaluate the toxicity of VcR-CVAD.
I. Evaluation of antigen expression patterns to determine or confirm possible unique
expressions of MCL.
II. To evaluate the percentage of circulating MCL cells.
OUTLINE: This is a multicenter study.
Induction therapy (VcR-CVAD): Patients receive VcR-CVAD comprising bortezomib IV over 3-5
seconds on days 1 and 4; rituximab IV over 3-4 hours on day 1; doxorubicin hydrochloride IV
over 48 hours on days 1 and 2; cyclophosphamide IV over 3 hours every 12 hours on days 1-3;
vincristine IV over 3-5 seconds on day 3; and dexamethasone IV or orally once daily on days
1-4. Patients also receive filgrastim (G-CSF) subcutaneously (SC) or IV once daily beginning
on day 5 or 6 and continuing until blood counts recover OR pegfilgrastim SC on day 5 or 6.
Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or
Maintenance therapy: Beginning 4-8 weeks after completion of induction therapy, patients
receive rituximab IV over 3-4 hours once weekly for 4 weeks. Treatment repeats every 6
months for up to 4 courses in the absence of disease progression or unacceptable toxicity.
After completion of induction therapy, patients who are eligible may have the option to
receive consolidation therapy for autologous stem cell transplantation (off-study). These
patients undergo stem cell harvest during courses 4, 5, or 6 of induction therapy.
After completion of study treatment, patients are followed periodically for up to 10 years.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Rate of CR defined as complete disappearance of all detectable clinical evidence of disease, and disease-related symptoms if present prior to therapy
Up to 10 years
Eastern Cooperative Oncology Group
United States: Food and Drug Administration
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