Patients suffering from high risk or relapsed leukaemia or high risk MDS can only occasionally be cured with conventional chemotherapy. Allogeneic stem cell transplantation (allo-SCT) has substantially improved the outcome of such patients due to a…
ID
Bron
Aandoening
Hematological malignancies (hematologische maligniteiten)
Allogeneic stem cells transplantation (allogene stamcel transplantatie)
Innate immune system (aangeboren immuunsysteem)
Ondersteuning
Heidelberglaan 100
3584 CX Utrecht
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Incidence of aGVHD at day 100.
Doel van het onderzoek
Patients suffering from high risk or relapsed leukaemia or high risk MDS can only occasionally be cured with conventional chemotherapy. Allogeneic stem cell transplantation (allo-SCT) has substantially improved the outcome of such patients due to a potent graft versus leukaemia effect after transplantation, however still for the high price of severe and life-threatening GVHD. Also relapses are frequently observed after allo-SCT. Recent reports have shown that the innate immune system can contribute to tumor control, whereas the development of GVHD appears to by lower as has been observed after conventional allo-SCT.
An "Innate-Tx" is a alpha/beta T cell depleted allograft, in which the innate immune cells are still present. The hypothesis is that via the depletion of the alpha/beta T cells the incidence of aGVHD will be lower, but that the remaining innate cells will provide infection and tumor control.
Onderzoeksopzet
End of study day 100
Time follow up 2 years
Onderzoeksproduct en/of interventie
Reduced toxicity myeloablative conditioning regime, alpha beta T-cell depleted stem cell graft.
Algemeen / deelnemers
J
Kuball
Lundlaan 6
Wetenschappers
J
Kuball
Lundlaan 6
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Adults
Haematological malignancies eligible to allo-SCT
WHO performance status ≤ 2
Written informed consent
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Relapse of allo-SCT within 6 months after allo-SCT
Bilirubin and/or transaminases > 2.5 x normal value
Creatinine clearance < 40 ml/min
Cardiac dysfunction as defined by (Unstable angina; Unstable cardiac arrhythmias)
Active, uncontrolled infection
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL4767 |
| NTR-old | NTR5013 |
| Ander register | NL48606.000.14 : 48606 |