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

This study has been completed.
Sponsor:
Collaborator:
Biogen Idec
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00177554
First received: September 13, 2005
Last updated: May 27, 2008
Last verified: May 2008
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PET-CT conversion rate [ Time Frame: May2007 ] [ Designated as safety issue: No ]
  • Frequency and severity of adverse events [ Time Frame: May 2007 ] [ Designated as safety issue: Yes ]
  • Duration of complete response [ Time Frame: May 2007,May 2008, May 2009, May 2010 ] [ Designated as safety issue: No ]
  • Time to next lymphoma therapy [ Time Frame: May 2207,May2008,May2009, May2010 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00177554

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

No publications provided by University of Pittsburgh

Additional 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
Study First Received: September 13, 2005
Last Updated: May 27, 2008
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 14, 2014