Clinical trial NCT04688021: A Single-arm Trial of Prophylactic Tocilizumab for Acute GVHD Prevention After Haploidentical HSCT.
Official title: A Single-arm, Single-center Trial of Prophylactic Tocilizumab for Acute GVHD Prevention After Haploidentical HSCT.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Leukemia
Graft-versus-host-disease
Keywords: hematopoietic stem cell transplantation
graft-versus-host disease
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
First posted: 2020-12-29
Enrollment: 46
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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 mycophenolate mofetil(MMF)+ATG) on day -1 of transplant. The previous patients will be used as control.

Eligibility 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

Primary outcomes:
measure: Cumulative incidence of grade II-IV acute graft-versus-host disease
timeFrame: 100 days
measure: Cumulative incidence of non grade II-IV acute graft-versus-host disease survival
timeFrame: 100 days
Secondary outcomes:
measure: Cumulative incidence of engraftment
timeFrame: 100 days
measure: Cumulative incidence of infections
timeFrame: 2 years
measure: Overall survival (OS)
timeFrame: 2 years
measure: Progression-free survival (PFS)
timeFrame: 2 years
measure: Cumulative incidence of transplant-related nonrelapse mortality (NRM)
timeFrame: 2 years
measure: Cumulative incidence of disease relapse or progression
timeFrame: 2 years
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The First Affiliated Hospital, College of Medicine, Zhejiang University
Study officials:
affiliation: First Affiliated Hospital of Zhejiang University
name: Yi Luo
role: PRINCIPAL_INVESTIGATOR
References: