DIFFUSE LARGE BCELL LYMPHOMA MedDRA version: 9.1 Level: LLT Classification code 10012818 Term: Diffuse large B-cell lymphoma
Conditions
Sponsors
AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Histologically confirmed, Ann Arbor stage II, III, or IV DLBCL according to the REAL/WHO classification (from initial diagnosis made prior to starting CHOP21-R therapy); 2. Central pathology review confirming the DLBCL 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: 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 CHOP21-R 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. Treatment with investigational drugs less than 4 weeks before the planned Day 1 or nonrecovery from the toxic effects of such therapy; 14. Surgery less than 4 weeks before the planned Day 1 or nonrecovery from the side effects of such surgery; 15. 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; 16. Unwillingness or inability to comply with the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of efficacy and safety of [90Y]-ibritumomab tiuxetan, as well as assessment of quality of life;Secondary Objective: 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 CHOP from 6-8 to 4.;Primary end point(s): Overall response rate and complete response rate will be the primary endpoints, | — |
Countries
Italy
Outcome results
None listed