Diffuse large B cell lymphoma Diffuus grootcellig B cel lymfoom
Conditions
Interventions
Patients will be injected with 10 mg 89Zr-ofatumumab (74 MBq) or 10 mg 89Zr-rituximab (74 MBq) intravenously, on the first day of the second-line treatment with respectively ofatumumab or rituximab pl
Sponsors
VU University Medical Center
Eligibility
Inclusion criteria
Inclusion criteria: Patients to be included must be before initiation of second-line treatment in or conform OMB 110928 study, meeting the following criteria (conform the inclusion criteria of OMB 110928 study protocol): 1. Patients have refractory or relapsed (see protocol for definition) CD20 positive DLBCL during or after first line treatment with rituximab combined with anthracycline-based chemotherapy, confirmed by biopsy after first line treatment; 2. Age 18 years or older; 3. Baseline 18F-FDG PET scan with positive lesions, compatible with CT defined anatomical tumor sites; 4. CT-scan showing at least one or more clearly demarcated lesions with a largest diameter larger or equal to 1.5 cm, or 1 clearly demarcated lesion with a largest diameter larger or equal to 2.0 cm (not previously irradiated); 5. ECOG performance status 0,1 or 2 6. Patients must be eligible for high dose chemotherapy and autologous stem cell transplantation; 7. Resolution of toxicities from first-line therapy to grade 1 or below; 8. Patients must be able to adhere to the study appointments and other protocol requirements; 9. Patients must be capable of giving written informed consent and the consent must have been obtained prior to the study related procedures.
Exclusion criteria
Exclusion criteria: Patients are excluded if they meet the following criteria (conform the exclusion criteria of OMB 110928 study protocol): 1. Any previous therapy for DLBCL, with the exception of first-line treatment with rituximab in combination with anthracycline-based chemotherapy, or radiotherapy as part of the first-line treatment plan or to a limited field at a maximum dose equal to or less than 10Gy to control life-threatening symptoms; 2. Received any of the following treatments within 4 weeks prior to start of trial therapy (unless otherwise stated): Anti-cancer therapy, radiotherapy (unless limited field at a maximum dose equal to or less than 10Gy to control life-threatening symptoms), treatment with any known non-marketed drug substance or experimental therapy within 5 terminal half lives or 4 weeks prior to enrolment (whichever is longer) or currently participating in any other interventional clinical study, glucocorticoid use, unless given in doses equal to or less than 100 mg/day hydrocortisone (or equivalent dose of other glucocorticoids) for < 7 days for exacerbations other than lymphoma (e.g. asthma); 3. Significant cerebrovascular disease; 4. Chronic or active infections with systemic treatment with antibiotics, antifungal or antiviral medication; 5. Other malignancy; 6. Prior treatment with monoclonal antibodies, with the exception of rituximab, within 3 months prior to start of the study; 7. Pregnancy or lactation; 8. Women of childbearing potential or male subjects, unable or unwilling to adhere to the adequate contraception conform study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The detection of 89Zr-ofatumumab and 89Zr-rituximab in DLBCL tumor lesions: 1. Visual (present/absent); 2. Quantitative (measured in peak Standardized Uptake Value (SUVpeak)). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The detection of 18F-FDG in DLBCL tumor lesions: A. Visual (present/absent); B. Quantitative (in SUVpreak). 2. The detection of 89Zr-ofatumumab and 89Zr-rituximab in normal tissue: A. Visual: Description of biodistribution; B. Quantitative (% uptake (of total injected) 89Zr-ofatumumab and 89Zr-rituximab, calculated residence times and calculated organ absorbed doses for 89Zr-ofatumumab and 89Zr-rituximab). 3. Clinical outcome: A. In categories: complete remission, partial remission, stable disease or relapsed/progressive disease, using the Revised Response Criteria for Malignant Lymphoma (RRMCML) for disease assessment, assessed by CT after the second cycle of therapy / by PET performed after the third cycle of therapy, conform OMB110928 study protocol. | — |
Contacts
Public ContactY.W.S. Jauw
VU University Medical Center Department of Hematology De Boelelaan 1117
Outcome results
None listed