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

December 11, 2019 updated by: University of Wisconsin, Madison
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VCR-CVAD with rituximab maintenance
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.
Drug: Bortezomib
Administered by IV at 1.3 mg/m2 days 1 and 4 of each 21 day cycle.
Other Names:
  • Velcade, PS-341
Drug: Rituximab
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).
Other Names:
  • Rituxan
Drug: Cyclophosphamide
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
Other Names:
  • cytoxan
Drug: 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.
Drug: Vincristine
1 mg administered by IV on day 3 of each cycle.
Drug: Dexamethasone
40 mg orally on days 1-4 of each cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)

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.
At completion of induction therapy (21 weeks)
Complete Response Rate (CR) at the End of Induction Chemotherapy
Time Frame: at 21 weeks
Complete Response Rate (CRR) as defined by 1999 International Working Group criteria, is defined as patients with complete disappearance of disease, or regression of all lymph nodes to 1.5 cm in greatest diameter or less. All subjects who had completed 2 cycles of therapy and had at least one disease evaluation, or had completed 1 cycle of therapy with progressive disease, were considered evaluable.
at 21 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3 Year Progression Free Survival
Time Frame: 36 months
This is the percent of subjects who had not had any recurrence or relapse of disease as of 3 years after enrollment in the study.
36 months
3 Year Overall Survival (OS)
Time Frame: 36 months
This is the percent of participants who were still alive at 3 years after study entry.
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Investigators

  • Principal Investigator: Brad S Kahl, MD, University of Wisconsin, Madison

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

December 19, 2007

First Submitted That Met QC Criteria

December 27, 2007

First Posted (Estimate)

December 28, 2007

Study Record Updates

Last Update Posted (Actual)

December 17, 2019

Last Update Submitted That Met QC Criteria

December 11, 2019

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HO05401
  • A534260 (Other Identifier: UW Madison)
  • SMPH\MEDICINE\HEM-ONC (Other Identifier: UW Madison)
  • 2011-0807 (Other Identifier: Institutional Review Board)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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