A phase I/ II study ;Efficacy and safety of alpha/ beta T- /CD19B-cell depleted allogeneic haematopoietic stem cells transplantation in high risk or relapsed acute leukaemia / MDS followed by an innate donor lymphocyte infusion (iDLI)

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,
but still for the high price of severe and life-threatening GvHD. Also relapses
are still observed after allo-SCT.

Objective: To test feasibility and safety of alpha beta T-/CD19 B-cell depleted
allo-SCT in high risk or relapsed acute leukaemia / MDS followed by an innate
donor lymphocyte infusion (iDLI)

Study design: Phase I/II study

Intervention: Myeloablative or non-myeloablative conditioning regime,alpha /
beta T-/CD19 B-cell depleted stem cell graft, short immunosuppression with
ciclosporine, immunomodulation with zoledronic acid and innate donor lymphocyte
infusion (iDLI).

Nature and extent of the burden and risks associated with participation,
benefit and group relatedness: The protocol comprises a different processing of
the donor stem cells source followed by innate DLI (iDLI). All other acts,
measurements, follow-up and level of care are similar to off-study patients
undergoing allo-SCT. The burden of the therapy is associated with the allo-SCT
itself which is a necessary therapeutic intervention in all subjects. Possible
increased risks of acute and cGvHD exist due to the earlier application of
immune cells. There is a possible increased risk engraftment failure due to T
cell depletion. However, we expect a lower mortality, secure engraftment, and
less relapse and infection due to NK- and **T-cell activity as well as a lower
risk of aGvHD and cGvHD