Phase 2 Hyper-CVAD/Rituximab for Untreated Mantle Cell Lymphoma

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

Phase II Pilot Study of Hyper-CVAD Plus Rituximab for Previously Untreated Mantle Cell Lymphoma

rituximab and modified (hyperCVAD) administered every 28 days for 4-6 cycles followed by rituximab maintenance therapy consisting of four weekly doses every six months for two years

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

rituximab and modified hyperfractionated cyclophosphamide, vincristine doxorubicin, dexamethasone (hyperCVAD) administered every 28 days for 4-6 cycles followed by rituximab maintenance therapy consisting of four weekly doses every six months for two years

Study Type

Interventional

Enrollment (Actual)

22

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
        • UWCCC

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:

  • Untreated mantle cell lymphoma

Exclusion Criteria:

  • Pregnant or breast feeding

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete Response Rate to Induction Therapy
Time Frame: Median follow up of 37 months
Outcome is the % of subjects who achieved a Complete Response (CR) or Complete Response Unconfirmed (CRu) after induction therapy, following the Cheson et al criteria for standardized response criteria (1999).
Median follow up of 37 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

June 1, 2000

Primary Completion (Actual)

June 1, 2006

Study Completion (Actual)

March 1, 2010

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 13, 2019

Last Update Submitted That Met QC Criteria

December 11, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HO00401

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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