Non-Myeloablative Conditioning for Unrelated Donor Umbilical Cord Blood Transplant

PHASE2CompletedINTERVENTIONAL
Enrollment

295

Participants

Timeline

Start Date

June 30, 2005

Primary Completion Date

December 12, 2019

Study Completion Date

December 12, 2019

Conditions
Myeloproliferative DisordersLeukemiaLymphomaMyelodysplastic Syndromes
Interventions
BIOLOGICAL

anti-thymocyte globulin

Equine ATG dose is 15 mg/kg intravenously (IV) every 12 hours for 6 doses on days -6, - 5, and -4.

DRUG

cyclophosphamide

Cyclophosphamide 50mg/kg x 1 to be administered IV over 2 hours with high volume fluid flush on day -6.

DRUG

Fludarabine

Fludarabine 40 mg/m2/day or 30 mg/m2/day intravenously (IV) as one hour infusion x 5 days, on day -6 to -2.

DRUG

mycophenolate mofetil

Mycophenolate mofetil (MMF) 3 gram/day 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.

PROCEDURE

umbilical cord blood transplantation

One or 2 UCB units may be infused to achieve the required cell dose.

RADIATION

total body irradiation

Administered Day -1, 200 cGy

DRUG

Sirolimus

Sirolimus will be administered starting at day -3 with 8mg-12mg mg oral loading dose followed by single dose 4 mg/day with a target serum concentration of 3 to 12 mg/mL. Levels are to be monitored 3 times/week in the first 2 weeks, weekly until day +60, and as clinically indicated until day +100 post-transplantation. In the absence of acute GVHD sirolimus may be tapered starting at day +100 and eliminated by day +180 post-transplantation.

Trial Locations (1)

55455

Masonic Cancer Center at University of Minnesota, Minneapolis

All Listed Sponsors
lead

Masonic Cancer Center, University of Minnesota

OTHER

NCT00305682 - Non-Myeloablative Conditioning for Unrelated Donor Umbilical Cord Blood Transplant | Biotech Hunter | Biotech Hunter