Non-Hodgkin Lymphoma
Conditions
Keywords
Non-Hodgkin 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.
Interventions
DRUGChemotherapy and Radioimmunotherapy
CHOP-R x 3 cycles followed by zevalin and extended rituximab
Sponsors
Biogen
University of Pittsburgh
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response rate | May 2007,May 2008, May2009, May 2010 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Time to next lymphoma therapy | May 2207,May2008,May2009, May2010 |
Countries
United States
Outcome results
None listed