NCT04688021

A Single-arm Trial of Prophylactic Tocilizumab for Acute GVHD Prevention After Haploidentical HSCT.

A Single-arm, Single-center Trial of Prophylactic Tocilizumab for Acute GVHD Prevention After Haploidentical HSCT.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: Yi Luo · Academic / Other
• Sex: All
• Age: 16 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

A single-arm trial using Tocilizumab for acute GVHD prophylaxis after haploidentical HSCT.

Detailed description

This study will enroll haploidentical HSCT patients with high risk for acute GVHD. Tocilizumab (8mg/kg) will be added to the conventional acute GVHD prophylaxis regime (CsA+Methotrexate(MTX)+low dose mycophenolate mofetil(MMF)+ATG) on day -1 of transplant. The previous patients will be used as control.

Conditions

• Leukemia
• Graft-versus-host-disease

Interventions

Type	Name	Description
DRUG	Cytarabine	4 mg/m2/day administered IV day -10 through -9.
DRUG	Busulfan	3.2 mg/kg/day administered IV day -8 through -6.
DRUG	Cyclophosphamide	1.8 g/m2/day administered IV day -5 through -4.
DRUG	Me-CCNU	250mg/m2 once administered orally on day -3.
DRUG	Rabbit antithymocyte globulin	1.5mg/kg/day administered IV day -5 through -2.
DRUG	Tocilizumab	8mg/kg administered IV on day -1.
PROCEDURE	Allogeneic HSCT	Day 0
DRUG	Cyclosporin A	2.5 mg/kg/day administered intravenously from day -7, target: 200-300ng/mL. Usually tapered during the second month, and ended in complete withdrawal during the ninth month after transplantation.
DRUG	Mycophenolate Mofetil	500 mg/day administered intravenously from day -9, ended in complete withdrawal on day +100.
DRUG	MTX	15 mg/m2 administered intravenously on day +1, 10mg/m2 on day +3, +6, and +9.

Timeline

• Start date: 2020-12-03
• Primary completion: 2024-12-03
• Completion: 2024-12-31
• First posted: 2020-12-29
• Last updated: 2023-02-21

Locations

1 site across 1 country: China