Tocilizumab for the Prevention of Graft Failure and GVHD in Haplo-Cord Transplantation

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

21

Participants

Timeline

Start Date

October 7, 2020

Primary Completion Date

September 28, 2022

Study Completion Date

May 31, 2027

Conditions
Hematologic MalignancyBone Marrow Transplant
Interventions
DRUG

Tocilizumab

Tocilizumab 8 mg/kg intravenously administered as a single dose on Day -1 of transplant conditioning regimen

DRUG

Fludarabine

Fludarabine 30 mg/m2 intravenously administered on Day -7, Day -6, Day -5, Day -4, Day -3 of transplant conditioning regimen if under the age of 60. If over the age of 60, Fludarabine 30 mg/m2 intravenously administered on Day -5, Day -4 and Day -3 of transplant conditioning regimen.

DRUG

Melphalan

Melphalan 140 mg/m2 intravenously administered on Day -2 of transplant conditioning regimen.

DRUG

Anti-thymocyte globulin (rabbit)

Anti-thymocyte globulin (ATG) 1.5 mg/kg

RADIATION

Total Body Irradiation

Total Body Irradiation (TBI) 2 Gray, administered on Day -4 and Day -3 of transplant conditioning regimen

Trial Locations (1)

10065

Weill Cornell Medical College, New York

All Listed Sponsors
lead

Weill Medical College of Cornell University

OTHER