Hematopoietic Stem Cell Transplantation in the Treatment of Infant Leukemia | Aplastic Anemia and MDS International Foundation

Clinical Trial: NCT00357565

Hematopoietic Stem Cell Transplantation in the Treatment of Infant Leukemia
For more details on this clinical trial, including contact information, please see this trial’s listing on clinicaltrials.gov:
Purpose: 

RATIONALE: Giving chemotherapy, such as busulfan, fludarabine, and melphalan, before a donor umbilical cord blood stem cell transplant helps stop the growth of abnormal or cancer cells and prepares the patient's bone marrow for the stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil may stop this from happening.

PURPOSE: This phase II trial is studying how well combination chemotherapy followed by a donor umbilical cord blood transplant works in treating infants with high-risk acute leukemia or myelodysplastic syndromes.

Status: 
Recruiting
Study Date: 
Thu, 12/01/2005 to Thu, 12/01/2016
Bone Marrow Disease(s): 
myelodysplastic syndromes (MDS)
Intervention: 
Biological: filgrastim All patients will receive G-CSF 5 mcg/kg/day intravenous (IV) (dose rounded to vial size) based on the actual body weight IV beginning on day +1 after umbilical cord blood (UCB) infusion. G-CSF will be administered daily until the absolute neutrophil count (ANC) exceeds 2.5 x 10^9/L for three consecutive days and then discontinued. If the ANC decreases to <1.0 x 10^9/L, G-CSF will be reinstituted. Other Name: G-CSF Drug: busulfan Administered 1.1 mg/kg if <12 kg intravenous (IV) every 6 hours (0.8 mg/kg if >12 kg IV every 6 hours on Days -8 through -5. Other Name: Busulfex Drug: cyclosporine Patients will receive cyclosporine (CSA) therapy beginning on day -3 maintaining a level of >200 ng/mL. For children < 40 kg the initial dose will be 2.5 mg/kg intravenous (IV) over 2 hours every 8 hours. Other Name: CSA Drug: fludarabine phosphate Administered 25 mg/m^2 intravenous (IV) over 60 minutes on Days -4 through -2. Other Name: Fludara Drug: melphalan Administered 60 mg/m^2 intravenous (IV) over 30 minutes on Days -4 through -2. Other Name: Alkeran Drug: mycophenolate mofetil All patients will begin mycophenolate mofetil (MMF) on day -3. Patients <45 kilograms will receive MMF at the dose of 15 mg/kg/dose every 8 hours (max dose 1gm/dose) orally or intravenously (PO or IV). Other Name: MMF Procedure: umbilical cord blood transplantation The product is infused via IV drip directly into the central line without a needle, pump or filter on Day 0.