Högdos Zevalin

Titel High Dose, Absorbed Dose Adjusted 90Y-Ibritumomab With PBSC Support in B-Cell Lymphoma
Akronym  
Typ av studie Fas I studie
Sponsor Universitetssjukhuset i  Lund
Inklusionskriterier
  • 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 HDCT with stem cell support or radiotherapy
  • Transformed B-cell lymphoma, failing first line therapy and not suitable for 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.
Studiedesign

Zevalin + autologt stamcellsstöd

Endpoint(s)
Rekryteringsperiod  
Antal inkluderade patienter  
Publikationer

 

   
Kontaktperson: Ola Lindén
   
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Uppdaterad: 2009 06 30