Assessment of tolerance and effectiveness of total body irradiation and cladribine before allogeneic hematopoietic cell transplantation in patients with acute myeloid leukemia and myelodysplastic syndromes

Prior treatment

• Treatment of any other investigational agent in the same time as this study.

Other illness

• Presence of active uncontrolled infection (i.e. sepsis, new symptoms, worsening physical signs or radiographic findings attributable to infection).
• Known active HIV, HBV or HCV infection (positive PCR test) or risk of HBV reactivation (HBsAg positive).
• Presence of active disease in AML patients.
• History or current diagnosis for uncontrolled or significant cardiac or pulmonary disease.
• Known allergies, hypersensivity, or intolerance to cladribine or similar compounds.

Lab values

• Presence of severely renal or liver dysfunction (creatinine, ALT, AST or bilirubin concentration > 3.0 ULN (upper limit of normal).

Other

• Has recived more than 1 allo-HCT.
• Women of childbearing potential who do not agree tmoust use two effective methods of contraception.
• Currently pregnancy or breast feeding.

• Age between 18 and 60 years (inclusive).
• Patient is a candidate for allo-HSCT due to AML (intermediate or high risk AML in complete remission, low risk with positive MRD) or high risk myelodysplastic syndrome.
• Demonstration of chemosensitivity in the case of treatment regimens with cladribine in induction therapy.
• Patient signed informed consent form (ICF) prior to any study related screening procedures are performed.
• Patient has ECOG performance status score of 0 or 1.
• Patient is a candidate for allo-HSCT from sibling or unrelated donor (full matched or 9/10 mismatched) or from haploidentical donor.