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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

September 13, 2005
May 27, 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 ] [ Designated as safety issue: No ]
Complete response rate
Complete list of historical versions of study NCT00177554 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

*   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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00177554
UPCI #03-005
Yes
Samuel Jacobs,MD, University of Pittsburgh cancer Institute
University of Pittsburgh
Biogen Idec
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