follicular grade I-II lymphoma MedDRA version: 9.1 Level: HLGT Classification code 10025320 Term: Lymphomas non-Hodgkin's B-cell
Conditions
Sponsors
AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 6 Histologically confirmed FL grade I-II according to the REAL/WHO classification (from initial diagnosis made prior to starting FMR therapy); 2. FLIPI ? 3; 3 3. Central pathology review confirming the FL grade I-II diagnosis and CD20 positivity, and no evidence/evidence with an infiltration =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Presence of any other malignancy or history of prior malignancy except non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma; 2. Prior radioimmunotherapy, radiation therapy, or any other NHL therapy; 3. Presence of gastric, central nervous system (CNS), or testicular lymphoma at first diagnosis; 4. Histological transformation of low-grade NHL; 5. Known seropositivity for hepatitis C virus (HCV) or hepatitis B surface antigen (HbsAg); 6. Known history of HIV infection; 7. Abnormal liver function: total bilirubin > 1.5 x ULN or ALT > 2.5 x ULN within 1 week of accrual; 8. Abnormal renal function: serum creatinine > 2.0 x ULN within 1 week of accrual; 9. Nonrecovery from the toxic effects of FMR therapy; 10. Known hypersensitivity to murine or chimeric antibodies or proteins; 11. G-CSF or GM-CSF therapy within two weeks (or four weeks if pegylated) prior to screening laboratory sampling; 12. Concurrent severe and/or uncontrolled medical disease (e.g., uncontrolled diabetes, congestive heart failure, myocardial infarction within 6 months of study, unstable anduncontrolled hypertension, chronic renal disease, or active uncontrolled infection) which could compromise participation in the study; 13. Male and female patients of child-bearing potential unwilling to practice effective contraception during the study and unwilling or unable to continue contraception for 12 months after their last dose of study treatment; 14. Female patients who are pregnant or are currently breastfeeding; 15. Treatment with investigational drugs less than 4 weeks before the planned Day 1 or nonrecovery from the toxic effects of such therapy; 16. Surgery less than 4 weeks before the planned Day 1 or nonrecovery from the side effects of such surgery; 17. Concurrent corticosteroid use for any reason except as premedication in case of known or suspected allergies to contrast media or as premedication for potential side effects of rituximab treatment; 18. Unwillingness or inability to comply with the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objectives of this study are to evaluate the efficacy and safety of the Zevalin study regimen after 4 cycles of FMR.;Secondary Objective: disease-free survival (DFS) and the rate of complete response will be the secondary endpoint. An additional secondary endpoint will be health-related quality of life(HRQL) considering that on this way (with introduction of Zevalin) we reduce the total number of cycles of conventional chemotherapy FM from 6-8 to 4.;Primary end point(s): Overall survival (OS) will be the primary endpoint, | — |
Countries
Italy
Outcome results
None listed