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.

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

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.

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