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

• Status: Recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yi Luo
• Treatments: Antilymphocyte Serum; Busulfan; Cyclophosphamide; Cyclosporine; Cyclosporins; Cytarabine; Mycophenolic Acid; Thymoglobulin

Criteria

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