Non-Hodgkin's lymphoma (NHL), B-Cell lymphoma
Conditions
Interventions
Infusion of Rituximab followed one week later by a second Rituximab infusion and a single dose of 90Y-ibritumomab tiuxetan.
Sponsors
Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON)
P/a HOVON Data Center
Erasmus MC - Daniel den Hoed
Postbus 5201
3008 AE Rotterdam
Tel: 010 7041560
Fax: 010 7041028
e-mail: hdc@erasmusmc.nl
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age >= 60 years old; 2. WHO performance status of 0-2; 3. Life expectancy of at least 3 months; 4. Histologically confirmed CD20 positive Diffuse large B-cell lymphoma (DLBCL), according to the WHO classification; 5. First-line induction treatment with R-CHOP or R-CHOP-like chemotherapy (only CHOP in combination with rituximab; CHOP14 and CHOP21 are both allowed); 6. Partial response on CT-scans after first-line treatment, with measurable disease; 7. PET-positive residual mass; 8. Patient is not eligible for high dose chemotherapy followed by autologous stem cell transplantation; 9. Less than 25% bone marrow involvement at the end of first-line treatment during PR analysis (measurement in a representative bone marrow biopsy); 10. Absolute neutrophil count (ANC) >= 1.5x10^9/l; 11. Hemoglobin (Hb) >= 6 mmol/l; 12. Platelets >= 150 x 10^9/l; 13. Written informed consent obtained according to local guidelines.
Exclusion criteria
Exclusion criteria: 1. Hypoplastic bone marrow at biopsy; 2. Prolonged pancytopenia during induction chemotherapy and delayed courses during R-CHOP induction (more than two weeks delay due to insufficient bone marrow reserve); 3. Known hypersensitivity to murine antibodies or proteins; 4. Significant splenomegaly; 5. Patients with abnormal liver function (total bilirubin > 2.0 x ULN); 6. Patients with abnormal renal function (serum creatinine > 2.0 x ULN); 7. Presence of CNS involvement by NHL; 8. 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; 9. More than one prior R-CHOP or R-CHOP-like chemotherapy regimen for DLBCL; 10. Patients who have received prior external beam radiotherapy to > 25% of active bone marrow (involved field or regional); 11. Patients who have received G-CSF or GM-CSF therapy within two weeks prior to study enrollment; 12. 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; 13. 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; 14. 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; 15. Known diagnosis of HIV infection; 16. Patients unwilling or unable to comply with the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response on FDG-PET (i.e. PET-negative residual masses). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Progression-free survival; 2. Overall survival; 3. Toxicity CTC AE grade 3-4. | — |
Contacts
Public ContactJ.M. Zijlstra
Postbus 7057
Outcome results
None listed