Status:
COMPLETED
High Dose, Absorbed Dose Adjusted 90Y-ibritumomab With Peripheral Blood Stem Cells (PBSC) Support in B-cell Lymphoma
Lead Sponsor:
Lund University Hospital
Collaborating Sponsors:
Bayer
Conditions:
B-cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00761384
Start Date
April 1 2008
End Date
January 1 2016
Last Update
February 19 2016
Active Locations (1)
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1
Lund University Hospital
Lund, Sweden, 221 85