UCB Transplant for Hematological Diseases Using a Non Myeloablative Prep

PHASE2CompletedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

May 15, 2017

Primary Completion Date

February 22, 2023

Study Completion Date

February 22, 2024

Conditions
Acute LeukemiaAcute Myeloid LeukemiaAcute Lymphoblastic Leukemia/LymphomaBurkitt's LymphomaNatural Killer Cell MalignanciesChronic Myelogenous LeukemiaMyelodysplastic SyndromeLarge-cell LymphomaHodgkin LymphomaMultiple MyelomaRelapsed Chronic Lymphocytic LeukemiaRelapsed Small Lymphocytic LymphomaMarginal Zone B-cell LymphomaFollicular LymphomaLymphoplasmacytic LymphomaMantle-cell LymphomaProlymphocytic LeukemiaBone Marrow Failure SyndromesMyeloproliferative Neoplasms/MyelofibrosisBiphenotypic/Undifferentiated/Prolymphocytic LeukemiasMRD Positive LeukemiaLeukemia or MDS in AplasiaRelapsed T-Cell LymphomaRelapsed Multiple MyelomaPlasma Cell Leukemia
Interventions
DRUG

Fludarabine

Both Arms: 30 mg/m\^2 IV over 1 hour Day -6 to Day -2

DRUG

Cyclophosphamide

Arm 1: 50 mg/kg IV over 2 hours Day -6

DRUG

MMF

"Both Arms:~Mycophenolate mofetil (MMF) 3 gram/day IV/PO for patients who are ≥ 40 kg divided in 2 or 3 doses. In obese patients (\>125% IBW) 15 mg/kg every 12 hours may be considered. Pediatric patient (\<40 kilograms) will receive MMF at the dose of 15 mg/kg/dose every 8 hours beginning Day -3. MMF dosing will be monitored and altered as clinically appropriate based on institutional guidelines. Patients will be eligible for MMF dosing and pharmacokinetics studies.~Stop MMF at Day +30 or 7 days after engraftment, whichever day is later, if no acute graft versus host disease (GVHD). (Definition of engraftment is 1st day of 3 consecutive days of absolute neutrophil count \[ANC) ≥ 0.5 x 109 /L\]). If no donor engraftment, do not stop MMF."

DRUG

Sirolimus

"Both Arms:~Adult Dosing: Sirolimus will be administered starting at Day -3 with 8-12 mg oral loading dose followed by single dose 4 mg/day with a target serum concentration of 3 to 12 mg/mL by high-performance liquid chromatography (HPLC) and will be monitored per institutional guidelines. In the absence of acute GVHD sirolimus may be tapered starting at Day +100 and eliminated by Day +180 post-transplantation.~Pediatric Dosing: Sirolimus will be administered starting on Day -3 with an oral loading dose of 10 mg followed by maintenance dosing of 2.5 mg/m\^2/day (Maximum total daily dose of 4mg) as per institutional guidelines. Target serum concentration goals are 3 to 12 mg/mL by high-performance liquid chromatography (HPLC) and will be monitored per institutional guidelines."

RADIATION

TBI

Both Arms: 200 cGy on Day -1

BIOLOGICAL

Umbilical cord blood cell infusion

Both Arms: Day 0

BIOLOGICAL

ATG

Arm 2: 15 mg/kg IV every 12 hours Day -6 to Day -4

Trial Locations (1)

55455

Masonic Cancer Center at University of Minnesota, Minneapolis

All Listed Sponsors
lead

Masonic Cancer Center, University of Minnesota

OTHER

NCT02722668 - UCB Transplant for Hematological Diseases Using a Non Myeloablative Prep | Biotech Hunter | Biotech Hunter