A Prospective Study With Individually Adjusted High Dose 90Y-Ibritumomab Tiuxetan Treatment With Peripheral Blood Stem Cells Support to Improve Outcome for Patients With Refractory/Recurrent B-cell Lymphoma, Stage II-IV
- 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
- Measurable disease and the tumor burden must be acceptable according to the
- 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.
- 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.