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

Yi Luo

Status and phase

Enrolling

Phase 2

Conditions

Leukemia

Graft-versus-host-disease

Treatments

Drug: Me-CCNU

Drug: Rabbit antithymocyte globulin

Drug: Busulfan

Drug: MTX

Drug: Cyclophosphamide

Procedure: Allogeneic HSCT

Drug: Cyclosporin A

Drug: Cytarabine

Drug: Tocilizumab

Drug: Mycophenolate Mofetil

Study type

Interventional

Funder types

Other

Identifiers

NCT04688021

TZ-001

Details and patient eligibility

About

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

Full 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.

Enrollment

46 estimated patients

Sex

All

Ages

16 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with hematological malignancies in complete remission (CR) who are eligible and planned for haploidentical HSCT. The donor specific antibody is negative
Patient age 16-60 years
Mother donor, or female donor (age >50) for female-male transplant
Eastern Cooperative Oncology Group (ECOG) performance status < 2
Creatinine clearance rate > 60 mL/min (estimate by Cockcroft-Gault Equation)
alanine transaminase (ALT) and aspartate aminotransferase (AST)≤ 2.5×upper limit of normal (ULN), and total bilirubin ≤ 1.5×ULN （upper limit of normal, ULN）
Left ventricular ejection fraction (LVEF) ≥50% as measured by echocardiography
Acceptation to sign the informed consent

Exclusion criteria

History of previous HSCT
Present active infection (including bacterial, virus or fungal)
History of Tocilizumab infection
History of inflammatory bowel disease
History of demyelinating disease
Patients who are HIV-positive, or with uncontrolled chronic hepatitis B virus (HBsAg positive) or hepatitis C virus (anti-HCV) infections
Women who are pregnant (β-chorionic gonadotropin+) or breast feeding
Refusal to sign the informed consent

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

46 participants in 1 patient group

Tocilizumab cohort

Experimental group

Description:

Each patient receives Tocilizumab (8 mg/kg, i.v.) on day -1 added to conventional acute GVHD prophylaxis regimen (CsA+MTX+low-dose MMF+ATG) of haploidentical HSCT.

Treatment: