An Exploratory, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of ATIR, Donor T-lymphocytes Depleted ex Vivo of Host Alloreactive T-cells, in Patients With a Hematologic Malignancy, Who Received a CD34-selected Hematopoietic Stem Cell Transplantation From a Haploidentical Donor

Study start date: March 1, 2013

Inclusion Criteria: Any of the following hematologic malignancies: a) Acute myeloid leukemia (AML) in first remission with high-risk features or in second or higher remission b) Acute lymphoblastic leukemia (ALL) in first remission with high-risk features or in second or higher remission c) Myelodysplastic syndrome (MDS): transfusion-dependent, or intermediate or higher Revised International Prognostic Scoring System (IPSS-R) risk group Eligible for haploidentical stem cell transplantation according to the investigator Exclusion Criteria: Availability of a suitable matched related or unrelated donor following a donor search In second or higher remission with the previous remission having lasted less than 6 months Diffusing capacity for carbon monoxide (DLCO) < 50% predicted Left ventricular ejection fraction < 50% (evaluated by echocardiogram or multiple gated acquisition [MUGA]) Aspartate aminotransferase (AST) > 2.5 x upper limit of normal (ULN)(CTCAE grade 2) Bilirubin > 1.5 x ULN (CTCAE grade 2) Creatinine clearance < 50 mL/min (calculated or measured) Positive test for human immunodeficiency virus (HIV) Positive pregnancy test (women of childbearing age only) Prior allogeneic stem cell transplantation using stem cells from a matched sibling donor, a matched unrelated donor, a haploidentical donor, or a cord blood donor Prior autologous stem cell transplantation Stay at intensive care unit for more than 2 months in the preceding 12 months Estimated probability of surviving less than 3 months Known allergy to any of the components of ATIR (e.g., dimethyl sulfoxide) Any other condition which, in the opinion of the investigator, makes the patient ineligible for the study Donor inclusion criteria Haploidentical family donor with 2 to 3 mismatches at the human leukocyte antigen (HLA)-A, -B and/or -DR loci of the unshared haplotype Male or female, age ≥ 16 and ≤ 75 years Eligible for donation according to the transplantation center Donor exclusion criteria Positive viral test for HIV-1, HIV-2, hepatitis B virus (HBV), hepatitis C virus (HCV), Treponema pallidum, human T-lymphotropic virus (HTLV)-1*, HTLV-2*, or West Nile virus (WNV)* (if tested) (* at Canadian centers only) Positive pregnancy test or nursing (women of childbearing age only)