patients with diffuse Large B-Cell lymphoma, CD20-positive MedDRA version: 8.1 Level: LLT Classification code 10012820 Term: Diffuse large B-cell lymphoma NOS
Conditions
Sponsors
HOVON Foundation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Age = 60 years old -WHO performance status of 0-2 (see Appendix E) -Life expectancy of at least 3 months -Histologically confirmed CD20 positive Diffuse large B-cell lymphoma (DLBCL), according to the WHO classification (see Appendix B) -First-line induction treatment with R-CHOP or R-CHOP-like chemotherapy (only CHOP in combination with rituximab; CHOP14 and CHOP21 are both allowed) -Partial response on CT-scans after first-line treatment, with measurable disease -PET-positive residual mass -Patient is not eligible for high dose chemotherapy followed by autologous stem cell transplantation -Less than 25% bone marrow involvement at the end of first-line treatment during PR analysis (measurement in a representative bone marrow biopsy) -Absolute neutrophil count (ANC) = 1.5 x 109/l -Hemoglobin (Hb) = 6 mmol/l -Platelets = 150 x 109/l -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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Hypoplastic bone marrow at biopsy -Prolonged pancytopenia during induction chemotherapy and delayed courses during R-CHOP induction (more than two weeks delay due to insufficient bone marrow reserve) -Known hypersensitivity to murine antibodies or proteins -Significant splenomegaly -Patients with abnormal liver function (total bilirubin > 2.0 x ULN) -Patients with abnormal renal function (serum creatinine > 2.0 x ULN) -Presence of CNS involvement by NHL -Presence of any other active neoplasms or history of prior malignancy, except non-melanoma skin tumours or stage 0 (in situ) cervical carcinoma during the past 5 years -More than one prior R-CHOP or R-CHOP-like chemotherapy regimen for DLBCL -Patients who have received prior external beam radiotherapy to > 25% of active bone marrow (involved field or regional) -Patients who have received G-CSF or GM-CSF therapy within two weeks prior to study enrollment -Concurrent severe and/or uncontrolled medical condition (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 -Patients who have received biologic therapy, immunotherapy, R-CHOP(-like) chemotherapy, surgery, or an investigational drugs less than 4 weeks prior to first day of study treatment or who have not recovered from the toxic effects of such therapy -Patients who have received systemic corticosteroids at doses higher than 20 mg/day prednisolone or equivalent less than 2 weeks prior to 90Y-ibritumomab tiuxetan administration -Known diagnosis of HIV infection -Patients unwilling or unable to comply with the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the conversion rate from PET-positive to PET-negative residual masses after 90Y-ibritumomab tiuxetan treatment in patients with PET-positive partial remission following first-line R-CHOP chemotherapy.;Secondary Objective: To evaluate the progression-free survival, the overall survival (OS) and the toxicity of DLBCL-patients with PET-positive partial remission treated with 90Y-ibritumomab tiuxetan.;Primary end point(s): Complete response on FDG-PET (i.e. PET-negative residual masses) | — |
Countries
Belgium
Outcome results
None listed