Tocilizumab for the Prevention of Graft Versus Host Disease After Cord Blood Transplantation

PHASE2CompletedINTERVENTIONAL
Enrollment

46

Participants

Timeline

Start Date

February 7, 2018

Primary Completion Date

April 18, 2025

Study Completion Date

April 18, 2025

Conditions
Acute Myeloid LeukemiaAcute Lymphoblastic LeukemiaAcute LeukemiaMyelodysplastic SyndromesMyelodysplastic-Myeloproliferative DiseasesMyeloproliferative DisorderNon Hodgkin LymphomaHodgkin LymphomaLeukemia
Interventions
RADIATION

Total Body Irradiation

Participants will receive a total dose of 400 cGy on day -2 and day -1 as 2 fractions (200 cGy x 2). Participants receiving total body irradiation (TBI) are treated in a standing position, and the treatment takes about 20 to 30 minutes.

DRUG

Cyclosporine

Dilute in D5W or NS to make a 2.5 mg/ ml solution. Infuse slowly over approximately 1-4 hours (intermittent infusion) or 24 hours for continuous infusion.

DRUG

Mycophenolate Mofetil

A 1000 mg dose should be placed in 140 ml of D5W. Administer only with D5W, over at least 2 hours.

DRUG

Tocilizumab

For participants \< 30kg, dilute with 50mL 0.9% sodium chloride. For participants ≥ 30kg, dilute to 100ml with 0.9% sodium chloride. Administer infusion over 60 minutes with infusion set.

DRUG

Filgrastim

The single use prefilled syringes contain either 300 mcg or 480 mcg Filgrastim at a fill volume of 0.5 mL or 0.8 mL, respectively. For the prevention/treatment of chemotherapy induced neutropenia, the dose of filgrastim is standardized per body weight: ≤ 60 kg = 300 mcg daily subcutaneously; \> 60 kg = 480 mcg subcutaneously daily.

Trial Locations (1)

10065

Memorial Sloan Kettering Cancer Center, New York

All Listed Sponsors
lead

Memorial Sloan Kettering Cancer Center

OTHER

NCT03434730 - Tocilizumab for the Prevention of Graft Versus Host Disease After Cord Blood Transplantation | Biotech Hunter | Biotech Hunter