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

Last updated: February 19, 2023
Sponsor: Yi Luo
Overall Status: Active - Recruiting

Phase

2

Condition

Leukemia

Treatment

N/A

Clinical Study ID

NCT04688021
TZ-001
  • Ages 16-60
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with hematological malignancies in complete remission (CR) who are eligibleand 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 ofnormal (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

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 (HBsAgpositive) or hepatitis C virus (anti-HCV) infections
  • Women who are pregnant (β-chorionic gonadotropin+) or breast feeding
  • Refusal to sign the informed consent

Study Design

Total Participants: 46
Study Start date:
December 03, 2020
Estimated Completion Date:
December 31, 2024

Study 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.

Connect with a study center

  • The First Affiliated Hospital, College of Medicine, Zhejiang University

    Hangzhou,
    China

    Active - Recruiting

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