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

Sponsor
Yi Luo
Study ID
NCT04688021
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
16 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Cytarabine — DRUG
    4 mg/m2/day administered IV day -10 through -9.
  • Busulfan — DRUG
    3.2 mg/kg/day administered IV day -8 through -6.
  • Cyclophosphamide — DRUG
    1.8 g/m2/day administered IV day -5 through -4.
  • Me-CCNU — DRUG
    250mg/m2 once administered orally on day -3.
  • Rabbit antithymocyte globulin — DRUG
    1.5mg/kg/day administered IV day -5 through -2.
  • Tocilizumab — DRUG
    8mg/kg administered IV on day -1.
  • Allogeneic HSCT — PROCEDURE
    Day 0
  • Cyclosporin A — DRUG
    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.
  • Mycophenolate Mofetil — DRUG
    500 mg/day administered intravenously from day -9, ended in complete withdrawal on day +100.
  • MTX — DRUG
    15 mg/m2 administered intravenously on day +1, 10mg/m2 on day +3, +6, and +9.

Study Details

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

Key Dates

Start date
Dec 3, 2020
Status verified
Feb 2023
Primary completion
Dec 3, 2024
Completion
Dec 31, 2024

Study Design

Enrollment
46 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Tocilizumab cohort
    Each patient receives Tocilizumab (8 mg/kg, i.v.) on day -1 added to conventional acute GVHD prophylaxis regimen (CsA+MTX+low-dose MMF+ATG) of haploidentical HSCT.

Primary Outcome Measure

Cumulative incidence of grade II-IV acute graft-versus-host disease [ Time Frame: 100 days ]

Central Contacts

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