B-cell Lymphoma
Conditions
Keywords
B-cell lymphoma, Refractory, Recurrent, 90Y-ibritumomab, Stem cells support, Dosimetry study
Brief summary
90Y-ibritumomab given with stem cells support, based on absorbed dose escalation to the liver. Absorbed dose escalation starts at 12 Gy and is capped at 36 Gy to the liver.
Interventions
DRUG90Y-ibritumomab
90Y-ibritumomab given with stem cells support, based on absorbed dose escalation to the liver. Absorbed dose escalation starts at 12 Gy and is capped at 36 Gy to the liver.
Sponsors
Bayer
Lund University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Written informed concent * Age at least 18 years * WHO Performance status 0-3 * Histologically verified B-cell lymphoma * Diffuse large B-cell lymphoma and follicular grade III, failing an anthracycline containing regimen and patients not found suitable for a second line chemotherapy consolidated by high dose chemotherapy (HDCT) with stem cell support or radiotherapy * Transformed B-cell lymphoma, failing first line therapy and not suitable for high dose chemotherapy (HDCT) or with a history of HDCT with stem cell support * Follicular lymphoma grade II and I, and other indolent lymphomas must have failed second line treatment. * One of these treatments must have contained chemotherapy and rituximab, the latter either together with chemotherapy or as maintenance. * The lymphoma must require treatment, Mantle cell lymphoma, failing first line treatment,treatment required * Measurable disease and the tumor burden must be acceptable according to the investigator * Radiological studies must be performed and a unilateral bone marrow biopsy within 4 weeks before start of treatment * Bone marrow reserve likely to give a harvest of at least 2x10 6 peripheral CD34+ stemcells or the existence of such a harvest or a corresponding central harvest * Total bilirubin should not exceed 40 micromole/L * A GFR as measured by Cystatin C of 50 ml/min * HIV, Hepatitis B and C status known * Life expectancy of at least 3 months.
Exclusion criteria
* Known or clinical evidence of CNS involvement * Bone marrow involvement at harvest as measured by biopsy and flow cytometry * Subjects with prior radiation to a field that includes over or equal 25% of their red marrow, liver or lung or to both kidneys * Prior chemotherapy or radiotherapy within 4 weeks * Subjects who are pregnant or nursing * Pulmonary involvement, that is not negligible at the discretion of the investigator * Liver involvement of lymphoma * History of hepatitis B or C.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximal tolerable dose (MTD) absorbed dose to the liver, safety and time to treatment failure (TTF) | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Overall response (OR), complete response (CR), their duration, absorbed dose to normal organ and tumours, relapse pattern, the effect of radioimmunotherapy (RIT) in its own right as assessed by positron emission tomography (PET) | 5 years |
Countries
Sweden
Outcome results
None listed