Phase II Trial of CHOP-R Followed by Zevalin and Rituxan in Follicular Lymphoma
Phase 2
Completed
- Conditions
- Non-Hodgkin Lymphoma
- Registration Number
- NCT00177554
- Lead Sponsor
- 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
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Complete response rate May 2007,May 2008, May2009, May 2010
- Secondary Outcome Measures
Name Time Method Time to next lymphoma therapy May 2207,May2008,May2009, May2010 PET-CT conversion rate May2007 Frequency and severity of adverse events May 2007 Duration of complete response May 2007,May 2008, May 2009, May 2010
Trial Locations
- Locations (1)
UPMC Cancer Centers
🇺🇸Pittsburgh, Pennsylvania, United States