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Completed

NCT Number: NCT00177554

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

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UPMC Cancer Centers

Pittsburgh, Pennsylvania, 15232, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chemotherapy and Radioimmunotherapy

Drug

CHOP-R x 3 cycles followed by zevalin and extended rituximab

Primary outcomes

  1. Complete response rate

    Time frame: May 2007,May 2008, May2009, May 2010

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • Biogen

Registry information

Important dates

Study start
2003
Primary completion
2007
Study completion
2007
First posted
Sep 15, 2005
Registry last updated
May 29, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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