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.

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)

Phase I / II
mono center

Myeloablative or non-myeloablative conditionering regime followed by alpha /
beta and CD 19 B cell depleted stem cell graft.
Short course of ciclosporine.
After discontinuation of ciclosporine and no sign of graft versus host disease
a donor lymphocyte inffusion (iDLI) will be given.

The protocol compromises a different processing of the donro stem cells source
followed by innate DLI (iDLI). All others 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 risk of acute and
chronic exist due to the earlier application of immune cells. There is a
possible increased risk of engraftment failure due to T cell depletion.
However, we expect a lower mortality, secure engraftment, and less relapse and
infection due to NK- and gamma/ delta cell activilty as well as lower risk of
acute and chronic GVHD.