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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
September 13, 2005
September 15, 2005
May 29, 2008
November 2003
May 2007   (Final data collection date for primary outcome measure)
Complete response rate [ Time Frame: May 2007,May 2008, May2009, May 2010 ]
Complete response rate
Complete list of historical versions of study NCT00177554 on ClinicalTrials.gov Archive Site
  • 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 ]
  • PET-CT conversion rate
  • Frequency and severity of adverse events
  • Duration of complete response
  • Time to next lymphoma therapy
Not Provided
Not Provided
 
Phase II Trial of CHOP-R Followed by Zevalin and Rituxan in Follicular Lymphoma
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
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.
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Non-Hodgkin Lymphoma
Drug: Chemotherapy and Radioimmunotherapy
CHOP-R x 3 cycles followed by zevalin and extended rituximab
Not Provided
Jacobs SA, Swerdlow SH, Kant J, Foon KA, Jankowitz R, Land SR, DeMonaco N, Joyce J, Osborn JL, Evans TL, Schaefer PM, Luong TM. Phase II trial of short-course CHOP-R followed by 90Y-ibritumomab tiuxetan and extended rituximab in previously untreated follicular lymphoma. Clin Cancer Res. 2008 Nov 1;14(21):7088-94. doi: 10.1158/1078-0432.CCR-08-0529.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
May 2007
May 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00177554
UPCI #03-005
Yes
Not Provided
Not Provided
Samuel Jacobs,MD, University of Pittsburgh cancer Institute
University of Pittsburgh
Biogen
Principal Investigator: Samuel A Jacobs, MD University of Pittsburgh
University of Pittsburgh
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP