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ACTIVE NOT RECRUITING
NCT04395222
PHASE2

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

Sponsor: Weill Medical College of Cornell University

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the safety of reducing and ultimately eliminating anti-thymocyte globulin (ATG) from the haplo-cord transplant conditioning regimen and replacing it with tocilizumab, an IL-6 receptor monoclonal antibody, to improve immune reconstitution and reduce relapse while preserving low rates of graft failure and graft versus host disease (GVHD).

Official title: A Prospective Study of Tocilizumab for the Prevention of Graft Failure and Graft-versus-Host Disease in Haplo-Cord Transplantation

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

21

Start Date

2020-10-07

Completion Date

2027-06

Last Updated

2026-01-06

Healthy Volunteers

No

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

Locations (1)

Weill Cornell Medical College

New York, New York, United States