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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Follicular
Lymphoma, Non-Hodgkin
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on October 19, 2014