Myeloablative Umbilical Cord Blood Transplantation in Hematological Diseases | Aplastic Anemia and MDS International Foundation

Clinical Trial: NCT00309842

Myeloablative Umbilical Cord Blood Transplantation in Hematological Diseases
For more details on this clinical trial, including contact information, please see this trial’s listing on clinicaltrials.gov:
Purpose: 

Giving chemotherapy drugs, such as fludarabine and cyclophosphamide, and total-body irradiation before a donor umbilical cord blood stem cell transplant helps stop the growth of 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 happen.

This phase II trial is studying how well giving fludarabine and cyclophosphamide together with total-body irradiation works in treating patients who are undergoing an umbilical cord blood transplant for hematologic cancer.

Status: 
Recruiting
Study Date: 
Fri, 07/01/2005 to Sat, 10/01/2016
Bone Marrow Disease(s): 
myelodysplastic syndromes (MDS)
Intervention: 
Biological: filgrastim All patients will receive G-CSF 5 mcg/kg/day intravenously(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. Other Name: G-CSF Drug: cyclophosphamide Cyclophosphamide to be administered with high volume fluid flush and mesna (MT(S) 9006) at 10:00am, or per institutional routine, on days-7 and -6 after fludarabine. Cyclophosphamide 60mg/kg/day intravenous (IV) x 2 days, total dose 120 mg/kg (days -7 and -6) Dosing is calculated based on Actual BodyWeight (ABW) unless ABW > 30 kg above Ideal BodyWeight (IBW), in which case the dose should be computed using adjusted body weight. Other Name: Cytoxan Drug: cyclosporine Patients will receive cyclosporine (CSA) therapy beginning on day -3 maintaining a level of > 200 ng/mL. For adults the initial dose will be 2.5 mg/kg intravenously (IV) over 2 hours every 12 hours. For children < 40 kg the initial dose will be 2.5 mg/kg IV over 2 hours every 8 hours. Other Name: CSA Drug: fludarabine phosphate Fludarabine 25 mg/m2/day intravenously (IV) x 3 days, total dose 75 mg/m2 (days -8 to -6); Other Name: Fludara Drug: mycophenolate mofetil All patients will begin mycophenolate mofetil (MMF) on day -3. Patients ≥ 40 kilograms will receive MMF at the dose of 3 grams/day divided into 2 or 3 doses (every 12 or 8 hours). Pediatric patient (<40 kilograms) will receive MMF at the dose of 15 mg/kg three times a day. Other Name: MMF Procedure: umbilical cord blood transplantation The product is infused via intravenous (IV) drip directly into the central line without a needle, pump or filter. Other Name: UCBT Radiation: total-body irradiation The recommended TBI is 165 cGy given twice daily for a total dose of 1320 cGy (days -4 to -1). Other Name: TBI