Conditions: Leukemia Myelodysplasia Acute Lymphocytic Leukemia Acute Myelogenous Leukemia
Keywords: Leukemia Myelodysplasia Acute lymphocytic leukemia ALL Acute myelogenous leukemia AML Pediatric
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 2
Healthy volunteers: no

Brief summary:
Unrelated Cord Blood (UCB) transplant in children is a viable stem cell transplant modality for patients with leukemia and myelodysplasia. UCB is now considered "Standard Of Care" in cases where a suitable living bone marrow donor is not available. The survival of UCB is similar to Matched Unrelated Marrow Transplant. This study is considered "Research" since UCB is not a licensed product and requires investigational new drug (IND). THERE ARE NO SPECIFIC RESEARCH QUESTIONS IN THIS PROTOCOL. This protocol merely provides UCB as a stem cell treatment modality to pediatric patients who may require it after a conditioning regimen that excludes Total Body Irradiation.

Detailed description:
The preparative regimen will consist of:

* Fludarabine: 25 mg/m2/day IV x 5 doses on Days -13, to -9
* Busulfan 1mg/kg IV every 6 hrs x 16 doses on Days -8 to -5
* Melphalan 45 mg/m2/day IV x 3 doses on days -4 to -2
* ATGAM 30mg/kg/day x 3 doses on Days -3 to -1
* Day 0 will be the day of the UCB Transplant
* The graft-versus-host-disease (GVHD) prophylaxis will be Cyclosporin A to maintain level 200-400 beginning on Day -3, through 200-400. Solumedrol at 1mg/kg/day on Day 1 until D+4, then solumedrol 2mg/kg/day until Day +19 or till absolute neutrophil count (ANC) reaches 500/mm2, then taper by 0.2 mg/kg/week.

Arms:
arm 1: Umbilical Cord Blood transfusion + Chemotherapy (Fludarabine + Busulfan + Melphalan)

Interventions: intervention 1: Umbilical Cord Blood Transfusion intervention 2: Fludarabine intervention 3: Busulfan intervention 4: Melphalan
Intervention descriptions: intervention 1: Following the administration of the preparative therapy, all subjects will undergo UCB transplantation. Umbilical Cord Blood Transfusion will occur on Day 0 intervention 2: Fludarabine 25 mg/m2/day will be administered over 30-60 minutes intravenous infusion on Days -13 through -9 for a total of 5 doses. Fludarabine will not be dose adjusted for body weight. intervention 3: Busulfan IV (Busulfex) will be administered IV every 6 hours on days -8 through -5 for a total of 16 doses. Seizure prophylaxis prior to first dose of busulfan till Day -3 will be administered. intervention 4: Melphalan 45 mg/m2/day will be administered over 60 minutes intravenous infusion on Days -4 through -2 for a total of 3 doses.

Protocol document: