A Modified Dose of Rabbit Anti-thymocyte Globulin (rATG) in Children and Adults Receiving Treatment to Help Prepare Their Bodies for a Bone Marrow Transplant

Inclusion Criteria

• •Patients receiving first peripheral blood mobilized ex-vivo CD34-selected T cell depleted allo-HCT for the following hematologic malignant conditions:
• •* Acute myeloid leukemia (AML) with intermediate or high-risk features in CR1 or Relapse AML in ≥ CR2.
• •* Must have MRD \<5% (flow cytometry, molecular and/or cytogenetics accepted).
• •* Acute leukemias of ambiguous lineage in ≥ CR1.
• •* Must have MRD \<5% (flow cytometry, molecular and/or cytogenetics accepted).
• •* Acute lymphoid leukemia (ALL) in CR1 with clinical, flow cytometric, or molecular features indicating a high risk for relapse, or ALL in ≥ CR2.
• •* Adult Patients - recommended but not required to be MRDnegative (by flow cytometry, molecular and/or cytogenetics).
• •* Pediatric Patients - Must be MRD-negative by flow cytometry, molecular and/or cytogenetics.
• •* Myelodysplastic syndromes (MDS) with least one of the following:
• •* Revised International Prognostic Scoring System risk score of intermediate or higher at the time of transplant evaluation.
• •* Life-threatening cytopenia.
• •* Karyotype or genomic changes that indicate high risk for progression to acute myelogenous leukemia, including abnormalities of chromosome 7 or 3, mutations of TP53, or complex or monosomal karyotype.
• •* Therapy related disease or disease evolving from other malignant processes.
• •Able to tolerate cytoreduction
• •Patients age:
• •* Regimen A: 4 - 60 years
• •* Regimen B - no age restriction
• •Adequate organ function is required, defined as follows:
• •* Hepatic: Serum bilirubin ≤ 2 mg/dL, unless benign congenital hyperbilirubinemia. Patients with hyperbilirubinemia related to paroxysmal nocturnal hemoglobinuria or other hemolytic disorders are eligible with PI approval.
• •* Hepatic: AST, ALT, and alkaline phosphatase \< 2.5 times the upper limit of normal unless thought to be disease-related.
• •* Renal: serum creatinine \<1.5x normal for age. If serum creatinine is outside the normal range, then CrCl \> 50 mL/min/1.73m2 (calculated or estimated) or GFR (mL/min/1.72m2) \>30% of predicted normal for age.
• •Normal GFR by Age
• •* 1 week 40.6 + / - 14.8
• •* 2 - 8 weeks 65.8 + / - 24.8
• •°\> 8 weeks 95.7 +/- 21.7
• •* 2 - 12 years 133 +/- 27
• •* 13 - 21 years (males) 140 +/- 30
• •* 13 - 21 years (females) 126.0 + / - 22.0
• •Cardiac: LVEF ≥ 50% by MUGA or resting echocardiogram.
• •Pulmonary: Pulmonary function testing (FEV1 and corrected DLCO) ≥ 50% predicted (pediatric patients unable to complete PFTs will need oxygen saturation as recorded by pulse oximetry of ≥92% on room air).
• •Adequate performance status:
• •* Age ≥ 16 years: ECOG ≤ 1 or Karnofsky 70%
• •* Age \< 16 years: Lansky 70%
• •Each patient must be willing to participate as a research subject and must sign an informed consent form or legal guardian with assent as appropriate.
• •Related or Unrelated Donors:
• •°8/8 HLA matched at A, B, C, and DRB1 loci, as tested by DNA analysis.
• •Able to provide informed consent for the donation process per institutional standards.
• •Meet standard criteria for donor collection (e.g. National Marrow Donor Program Guidelines or collecting center guidelines as approved by treating physician).
• •Provide GSCF mobilized peripheral blood stem cells