Status:
UNKNOWN
A Single-arm Trial of Prophylactic Tocilizumab for Acute GVHD Prevention After Haploidentical HSCT.
Lead Sponsor:
Yi Luo
Conditions:
Leukemia
Graft-versus-host-disease
Eligibility:
All Genders
16-60 years
Phase:
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT04688021
Start Date
December 3 2020
End Date
December 31 2024
Last Update
February 21 2023
Active Locations (1)
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1
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, China