Matched Unrelated vs. Haploidentical Donor for Allogeneic Stem Cell Transplantation in Patients With Acute Leukemia

Prior treatment

• Participation in another study with ongoing use of unlicensed investigational product from 28 days before study enrollment.

Other illness

• Positive serology for HIV.
• Uncontrolled invasive fungal infection at time of screening (baseline).
• Serious psychiatric or psychological disorders.
• Uncontrolled severe autoimmune disease or uncontrolled other malignancy.

Lab values

• Severe renal, hepatic, pulmonary or cardiac disease, such as:
  • total bilirubin, SGPT or SGOT \> 3 times upper the normal level
  • left ventricular ejection fraction \< 30 %
  • creatinine clearance \< 30 ml/min
  • DLCO \< 35 % and/or receiving supplementary continuous oxygen
• Pregnant or lactating women (positive serum pregnancy test).

Age

• Age \< 18 and ≥ 71 years.

Other

• Availability of an HLA-identical sibling as donor source.

• Acute Myeloid Leukemia (AML) intermediate or high risk according to ELN or Acute Lymphoblastic Leukemia (ALL) high risk according to ESMO guidelines in 1. CR or AML/ALL in 2. CR, or high risk MDS (according to IPSS-R) in 1. CR or 2. CR.
• Patients age: 18 - 70 years at time of inclusion (female and male).
• Patients understand and voluntarily sign an informed consent form.
• ECOG ≤ 2.
• 10/10 HLA-matched unrelated donor and haploidentical (≥ 5/10 and ≤ 8/10 HLA) relative matched donor available at least 4 weeks after completion of induction and/or consolidation therapy.
• Females/Males who agree to comply with the applicable contraceptive requirements of the protocol.