Umbilical Cord Blood Transplantation Using a Myeloablative Preparative Regimen for Hematological Diseases

NARecruitingINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

December 31, 2016

Primary Completion Date

October 31, 2025

Study Completion Date

October 31, 2026

Conditions
Acute Myeloid Leukemia (AML)Acute Lymphocytic Leukemia (ALL)Chronic Myelogenous LeukemiaPlasma Cell LeukemiaMyelofibrosisMyelodysplasiaChronic Lymphocytic LeukemiaSmall Lymphocytic LymphomaMarginal Zone B-Cell LymphomaFollicular LymphomaLymphoplasmacytic LymphomaMantle-Cell LymphomaProlymphocytic LeukemiaDiffuse Large B Cell LymphomaLymphoblastic LymphomaBurkitt's LymphomaNon-Hodgkin LymphomaMultiple Myeloma
Interventions
DRUG

Fludarabine

25 mg/m\^2 IV of Fludarabine will be given over 1 hour on days -8, -7, and -6 pre-UCB transplant.

DRUG

Cyclophosphamide

60 mg/kg IV of Cyclophosphamide will be given over 2 hours on days -7 and -6 pre-UCB transplant.

RADIATION

Total Body Irradiation

165 cGy of total body irradiation will be given twice a day on days -4, -3, -2, and -1.

DRUG

Cyclosporine A

Cyclosporine A (CSA) will start day -3 and will be administered PO/IV maintaining a trough level between 200 and 400 ng/mL. For adults the initial dose will be 2.5 mg/kg IV over 1 hour every 12 hours. For children \< 40 kg the initial dose will be 2.5 mg/kg IV over 1 hour every 8 hours.

DRUG

Mycophenylate mofetil

Mycophenylate mofetil (MMF) 3 gram/day IV/PO for patients who are ≥ 40 kg divided in 2 or 3 doses. Pediatric patient (\<40 kilograms) will receive MMF at the dose of 15 mg/kg/dose every 8 hours beginning day -3.

BIOLOGICAL

Umbilical cord blood

Pre-medications and UCB infusion will be per current institutional policies/guidelines. The infusion of the first UCB unit should begin within 15 minutes, and no later than 30 minutes after arrival on the Unit. If 2 units are used, both cords will be infused within 30-60 minutes of each other as deemed clinically safe by the BMT attending or designee.

Trial Locations (1)

55455

RECRUITING

University of Minnesota Masonic Cancer Center, Minneapolis

All Listed Sponsors
lead

Masonic Cancer Center, University of Minnesota

OTHER

NCT01962636 - Umbilical Cord Blood Transplantation Using a Myeloablative Preparative Regimen for Hematological Diseases | Biotech Hunter | Biotech Hunter