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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
46
4 mg/m2/day administered IV day -10 through -9.
3.2 mg/kg/day administered IV day -8 through -6.
1.8 g/m2/day administered IV day -5 through -4.
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, China
RECRUITINGCumulative incidence of grade II-IV acute graft-versus-host disease
Date of symptom onset, maximum clinical grade, and dates and types of treatment will be recorded. Dates of symptom onset of grade II-IV acute graft-versus-host disease (aGVHD) will be recorded. The aGVHD score of each affected organ will be recorded.
Time frame: 100 days
Cumulative incidence of non grade II-IV acute graft-versus-host disease survival
All patients will be tracked from Day 0 to date of grade II-IV acute graft-versus-host disease (aGVHD) onset. Patients who did not present grade II-IV aGVHD or died will be censored at the last date they were assessed and deemed free of grade II-IV aGVHD.
Time frame: 100 days
Cumulative incidence of engraftment
All patients will be tracked from Day 0 to date of myeloid and platelet engraftments, respectively.
Time frame: 100 days
Cumulative incidence of infections
All patients will be tracked from Day 0 to date of infection diagnosis as proved by relevant standard diagnostic criteria.
Time frame: 2 years
Overall survival (OS)
All patients will be tracked from Day 0 to date of first objective disease progression, death from any cause, or last patient evaluation. Patients who have not progressed or died will be censored at the last date they were assessed and deemed free of relapse or progression.
Time frame: 2 years
Progression-free survival (PFS)
All patients will be tracked from Day 0 to date of first objective disease progression, death from any cause, or last patient evaluation. Patients who have not progressed or died will be censored at the last date they were assessed and deemed free of relapse or progression.
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250mg/m2 once administered orally on day -3.
1.5mg/kg/day administered IV day -5 through -2.
8mg/kg administered IV on day -1.
Day 0
2.5 mg/kg/day administered intravenously from day -7, target: 200-300ng/mL. Usually tapered during the second month, and ended in complete withdrawal during the ninth month after transplantation.
500 mg/day administered intravenously from day -9, ended in complete withdrawal on day +100.
15 mg/m2 administered intravenously on day +1, 10mg/m2 on day +3, +6, and +9.
Time frame: 2 years
Cumulative incidence of transplant-related nonrelapse mortality (NRM)
All patients will be tracked from Day 0 to date of first objective disease progression, death from any cause, or last patient evaluation. Patients who have not progressed or died will be censored at the last date they were assessed and deemed free of relapse or progression.
Time frame: 2 years
Cumulative incidence of disease relapse or progression
All patients will be tracked from Day 0 to date of first objective disease progression, death from any cause, or last patient evaluation. Patients who have not progressed or died will be censored at the last date they were assessed and deemed free of relapse or progression.
Time frame: 2 years