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Clinical Trial · NCT00761384
High Dose, Absorbed Dose Adjusted 90Y-ibritumomab With Peripheral Blood Stem Cells (PBSC) Support in B-cell Lymphoma
Overview
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.
Sponsor
Turku University Hospital
Phase
Phase 1/2
Contacts
Ola Lindén, MD (PRINCIPAL_INVESTIGATOR)
ClinicalTrials.gov
NCT00761384Drug / Compound
ibritumomab
Isotope(s):
YTTRIUM-90
Radioisotope: Y-90
Theranostic Role: Therapeutic Agent, SPECT Imaging & PET Imaging
T1/2 (Half-Life): 2.7 Days
Decay Mode: BETA
Energy: max 2.2 MeV
Range: In Tissue: Avg 2.5 mm, Max 11 mm; In Air: 35 feet
Decay Daughters: Zr90 (Stable)
Status: FDA Approvals: SIR-SPHERES® (2000), THERASPHERES® (2021)
Target(s):
- CD20 antigen
Ligand Class: Antibodies
Chelator: tiuxetan
Eligibility
Inclusion
- Written informed concent
- 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
- Radiological studies must be performed and a unilateral bone marrow biopsy within 4 weeks before start of treatment
- Follicular lymphoma grade II and I, and other indolent lymphomas must have failed second line treatment.
- Measurable disease and the tumor burden must be acceptable according to the investigator
- 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
- Life expectancy of at least 3 months.
- WHO Performance status 0-3
- One of these treatments must have contained chemotherapy and rituximab, the latter either together with chemotherapy or as maintenance.
- 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
- Histologically verified B-cell lymphoma
- HIV, Hepatitis B and C status known
- The lymphoma must require treatment, Mantle cell lymphoma, failing first line treatment,treatment required
- Total bilirubin should not exceed 40 micromole/L
- A GFR as measured by Cystatin C of 50 ml/min
Exclusion
- Subjects who are pregnant or nursing
- Subjects with prior radiation to a field that includes over or equal 25% of their red marrow, liver or lung or to both kidneys
- Pulmonary involvement, that is not negligible at the discretion of the investigator
- Bone marrow involvement at harvest as measured by biopsy and flow cytometry
- Liver involvement of lymphoma
- History of hepatitis B or C.
- Prior chemotherapy or radiotherapy within 4 weeks
- Known or clinical evidence of CNS involvement
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