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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Mantle Cell Lymphoma

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome 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).

Outcome 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.

Outcome Time Frame:

At completion of induction therapy (21 weeks)

Safety Issue:

No

Principal Investigator

Brad S Kahl, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Wisconsin, Madison

Authority:

United States: Institutional Review Board

Study ID:

HO05401

NCT ID:

NCT00581776

Start Date:

May 2005

Completion Date:

November 2013

Related Keywords:

  • Mantle Cell Lymphoma
  • Untreated Mantle Cell Lymphoma
  • Lymphoma
  • Lymphoma, Mantle-Cell

Name

Location
University of Wisconsin Cancer Center Madison, Wisconsin  53792