Myeloablative Umbilical Cord Blood Transplantation in Hematological Diseases

PHASE2CompletedINTERVENTIONAL
Enrollment

213

Participants

Timeline

Start Date

July 28, 2005

Primary Completion Date

July 29, 2019

Study Completion Date

November 22, 2019

Conditions
Acute Myeloid LeukemiaAcute Lymphocytic LeukemiaChronic Myelogenous LeukemiaMyelofibrosisMDSRefractory AnemiaChronic Lymphocytic LeukemiaProlymphocytic LeukemiaNon-Hodgkin's LymphomaLeukemiaLymphomaMultiple MyelomaMyelodysplastic Syndromes
Interventions
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.

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.

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.

DRUG

fludarabine phosphate

Fludarabine 25 mg/m2/day intravenously (IV) x 3 days, total dose 75 mg/m2 (days -8 to -6);

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."

PROCEDURE

umbilical cord blood transplantation

The product is infused via intravenous (IV) drip directly into the central line without a needle, pump or filter.

RADIATION

total-body irradiation

The recommended TBI is 165 cGy given twice daily for a total dose of 1320 cGy (days -4 to -1).

Trial Locations (2)

55455

Masonic Cancer Center at University of Minnesota, Minneapolis

98109

Fred Hutchinson Cancer Research Center, Seattle

All Listed Sponsors
lead

Masonic Cancer Center, University of Minnesota

OTHER

NCT00309842 - Myeloablative Umbilical Cord Blood Transplantation in Hematological Diseases | Biotech Hunter | Biotech Hunter