Intra-Osseous Co-Transplant of UCB and hMSC

EARLY_PHASE1CompletedINTERVENTIONAL
Enrollment

6

Participants

Timeline

Start Date

July 22, 2015

Primary Completion Date

December 19, 2019

Study Completion Date

February 7, 2020

Conditions
Acute Lymphoblastic LeukemiaAcute Myelogenous LeukemiaMyelodysplastic SyndromesMyelofibrosisRelapsed Non-Hodgkin LymphomaRefractory Non-Hodgkin LymphomaHodgkin LymphomaRefractory Hodgkin LymphomaRelapsed Chronic Lymphocytic LeukemiaRefractory Chronic Lymphocytic LeukemiaLymphoid MalignanciesChronic Myelogenous Leukemia
Interventions
DRUG

cyclophosphamide

All patients will receive a single IV dose of 50 mg/kg of cyclophosphamide on day -6

DRUG

fludarabine phosphate

Given by IV during prep at 40mg/m2 for 5 days

RADIATION

total-body irradiation

Undergo single fraction of reduced intensity conditioning (RIC) regimen of 200 cGy TBI without shielding on day -1

DRUG

cyclosporine

Initiated in patients on the day -5. Cyclosporine will be administered orally or intravenously at 2 mg/kg/dose every 12 hours for 2-hour period. Cyclosporine will continue until day +100

DRUG

mycophenolate mofetil

Given at 1g intravenously or orally twice daily from day -5 to +100, or as clinically indicated.

PROCEDURE

umbilical cord blood transplantation

Following RIC, on day T+0, dimethylsulphoxide will be removed from the cord blood cells and given as transplant.

PROCEDURE

mesenchymal stem cell transplantation

The total dosage of hMSC will be 2x10\^6cells/kg (+/-20%).

Trial Locations (1)

44106-5065

Case Comprehensive Cancer Center, Cleveland

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Case Comprehensive Cancer Center

OTHER

NCT02181478 - Intra-Osseous Co-Transplant of UCB and hMSC | Biotech Hunter | Biotech Hunter