Phase II Trial of CHOP-R Followed by Zevalin and Rituxan in Follicular Lymphoma
This study has been completed.
Sponsor:
University of Pittsburgh
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
Tracking Information | |||||
---|---|---|---|---|---|
First Received Date ICMJE | September 13, 2005 | ||||
Last Updated Date | May 27, 2008 | ||||
Start Date ICMJE | November 2003 | ||||
Primary Completion Date | May 2007 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Complete response rate [ Time Frame: May 2007,May 2008, May2009, May 2010 ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE |
Complete response rate | ||||
Change History | Complete list of historical versions of study NCT00177554 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
|
||||
Original Secondary Outcome Measures ICMJE |
|
||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Phase II Trial of CHOP-R Followed by Zevalin and Rituxan in Follicular Lymphoma | ||||
Official Title ICMJE | Phase II Trial of CHOP-R Followed by Zevalin and Rituxan in Follicular Lymphoma | ||||
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 |
||||
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. |
||||
Study Type ICMJE | Interventional | ||||
Study Phase | Phase 2 | ||||
Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
||||
Condition ICMJE | Non-Hodgkin Lymphoma | ||||
Intervention ICMJE | Drug: Chemotherapy and Radioimmunotherapy
CHOP-R x 3 cycles followed by zevalin and extended rituximab |
||||
Study Arm (s) | |||||
Publications * | 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. |
|||||
Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 60 | ||||
Completion Date | May 2007 | ||||
Primary Completion Date | May 2007 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00177554 | ||||
Other Study ID Numbers ICMJE | UPCI #03-005 | ||||
Has Data Monitoring Committee | Yes | ||||
Responsible Party | Samuel Jacobs,MD, University of Pittsburgh cancer Institute | ||||
Study Sponsor ICMJE | University of Pittsburgh | ||||
Collaborators ICMJE | Biogen Idec | ||||
Investigators ICMJE |
|
||||
Information Provided By | University of Pittsburgh | ||||
Verification Date | May 2008 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |