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

NCT04688021 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2023-02-21

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

Cytarabine

4 mg/m2/day administered IV day -10 through -9.

DRUG

Busulfan

3.2 mg/kg/day administered IV day -8 through -6.

DRUG

Cyclophosphamide

1.8 g/m2/day administered IV day -5 through -4.

DRUG

Me-CCNU

250mg/m2 once administered orally on day -3.

DRUG

Rabbit antithymocyte globulin

1.5mg/kg/day administered IV day -5 through -2.

DRUG

Tocilizumab

8mg/kg administered IV on day -1.

PROCEDURE

Allogeneic HSCT

Day 0

DRUG

Cyclosporin A

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.

DRUG

Mycophenolate Mofetil

500 mg/day administered intravenously from day -9, ended in complete withdrawal on day +100.

DRUG

MTX

15 mg/m2 administered intravenously on day +1, 10mg/m2 on day +3, +6, and +9.

Sponsors & Collaborators

  • Yi Luo

    lead OTHER

Principal Investigators

  • Yi Luo · First Affiliated Hospital of Zhejiang University

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-03
Primary Completion
2024-12-03
Completion
2024-12-31

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04688021 on ClinicalTrials.gov