High Dose, Absorbed Dose Adjusted 90Y-ibritumomab With Peripheral Blood Stem Cells (PBSC) Support in B-cell Lymphoma

• Status: Completed
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lund University Hospital
• Collaborator: Bayer

Criteria

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.