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

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. Identifier: NCT00177554
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : May 29, 2008
Information provided by:
University of Pittsburgh

Brief Summary:
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 or disease Intervention/treatment Phase
Non-Hodgkin Lymphoma Drug: Chemotherapy and Radioimmunotherapy Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
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
Study Start Date : November 2003
Actual Primary Completion Date : May 2007
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab

Intervention Details:
  • Drug: Chemotherapy and Radioimmunotherapy
    CHOP-R x 3 cycles followed by zevalin and extended rituximab

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

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

Information from the National Library of Medicine

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

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

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 identifier (NCT number): NCT00177554

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

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

Keywords provided by University of Pittsburgh:
Non-Hodgkin Lymphoma

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