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Phase II Trial of CHOP-R Followed by Zevalin and Rituxan in Follicular Lymphoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00177554
First Posted: September 15, 2005
Last Update Posted: May 29, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Biogen
Information provided by:
University of Pittsburgh
  Purpose
The purpose of this study is to determine the complete response rate when CHOP-R chemotherapy in followed by Zevalin in previous untreated patients with follicular lymphoma

Condition Intervention Phase
Non-Hodgkin Lymphoma Drug: Chemotherapy and Radioimmunotherapy Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of CHOP-R Followed by Zevalin and Rituxan in Follicular Lymphoma

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Complete response rate [ Time Frame: May 2007,May 2008, May2009, May 2010 ]

Secondary Outcome Measures:
  • PET-CT conversion rate [ Time Frame: May2007 ]
  • Frequency and severity of adverse events [ Time Frame: May 2007 ]
  • Duration of complete response [ Time Frame: May 2007,May 2008, May 2009, May 2010 ]
  • Time to next lymphoma therapy [ Time Frame: May 2207,May2008,May2009, May2010 ]

Enrollment: 60
Study Start Date: November 2003
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Chemotherapy and Radioimmunotherapy
    CHOP-R x 3 cycles followed by zevalin and extended rituximab
Detailed Description:
Patients with follicular lymphoma who require therapy and have been previously untreated are eligible for this non-randomized, phase II study evaluating up front therapy with CHOP-R x 3 cycles followed by zevalin and 4 additional weeks of rituxan.The complete response will be determined by combining IWC criteria and PET scanning.Secondary objectives include PET-CT conversion rate, frequency and severity of adverse events, duration of complete remission and time to next lymphoma therapy.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Conformed diagnosis of follicular lymphoma, grades 1,2 or 3
  • No prior chemotherapy
  • No prior monoclonal antibody therapy
  • Bulky or symptomatic disease, stage II-IV
  • Performance status 0-2

Exclusion Criteria:

  • Impaired bone marrow reserve
  • Presence of CNS lymphoma
  • Serious nonmalignant disease or active infection
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00177554


Locations
United States, Pennsylvania
UPMC Cancer Centers
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
University of Pittsburgh
Biogen
Investigators
Principal Investigator: Samuel A Jacobs, MD University of Pittsburgh
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Samuel Jacobs,MD, University of Pittsburgh cancer Institute
ClinicalTrials.gov Identifier: NCT00177554     History of Changes
Other Study ID Numbers: UPCI #03-005
First Submitted: September 13, 2005
First Posted: September 15, 2005
Last Update Posted: May 29, 2008
Last Verified: May 2008

Keywords provided by University of Pittsburgh:
Non-Hodgkin Lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents