Diffuse large B-cell lymphoma
Conditions
Interventions
Product Name: Zevalin
Pharmaceutical Form: Kit for radiopharmaceutical preparation
INN or Proposed INN: Ibritumomab tiuxetan
CAS Number: 174722-31-7
Concentration unit: mg/ml milligram(s)/millilitre
C
Sponsors
Schering AG, Global Medical Development
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed, Ann Arbor stage II, III, or IV DLBCL according to the REAL/WHO classification (from initial diagnosis made prior to starting CHOP-R therapy) 2. Central pathology review confirming the DLBCL diagnosis and CD20 positivity, and no evidence of DLBCL in bone marrow 3. First-line treatment of DLBCL must have been 6 or 8 cycles of standard CHOP chemotherapy (cyclophosphamide 750 mg/m2, doxorubicin 50 mg/m2, vincristine 1.4 mg/m2 up to a maximum of 2 mg on day 1, and at least 40 mg/m2/day prednisone on Days 1 to 5 every three weeks, with generally accepted adjustments in dose or frequency due to toxicity, patient scheduling, etc.) in combination with rituximab (375 mg/m2) 4. Complete remission (CR) or unconfirmed complete remission (CRu) according to the International Workshop Response Criteria for NHL described by Cheson et al and modified for this study (see Appendix 2) after first-line treatment with CHOP- R. CT scans of chest, abdomen, pelvis, and neck (if applicable) must have been performed within 6 weeks after the last dose of the last course of CHOP R. Applicability of the neck CT means that the patient had involvement of the neck region by palpation / physical examination at first diagnosis 5. Central radiographic review of the CT scans (chest, abdomen, pelvis and if applicable, neck) from before and after first-line treatment with CHOP-R fulfilling the radiological requirements for CR/CRu 6. Patients 60-years-of-age or older at time of randomization 7. WHO performance status (PS) of 0 to 2 within 1 week of randomization 8. Absolute neutrophil count (ANC) > 1.5 x 109/L within 1 week of randomization 9. Hemoglobin (Hgb) > 10 g/dL within 1 week of randomization 10. Platelets > 150 x 109/L within 1 week of randomization 11. Life expectancy of 3 months or longer 12. Written informed consent obtained according to local guidelines Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=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 except first-line CHOP-R 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 randomization 8. Abnormal renal function: serum creatinine > 2.0 x ULN within 1 week of randomization 9. Nonrecovery from the toxic effects of CHOP-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 and uncontrolled 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 |
|---|---|
| Secondary Objective: Disease-free survival (DFS) will be the secondary endpoint. An additional secondary endpoint will be health-related quality of life (HRQL) as assessed by the patient using standard questionnaires (FACT-G and EuroQoL EQ-5D).;Primary end point(s): Overall survival;Main Objective: To evaluate the efficacy and safety of the Zevalin study regimen compared with observation alone in patients with DLBCL who are in complete remission (CR or CRu) after first-line CHOP-R. Overall survival (OS) will be the primary endpoint. | — |
Countries
Austria, Finland, Germany, Hungary, Ireland, Italy, Portugal, Spain, Sweden, United Kingdom
Outcome results
None listed