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Efficacy of Basiliximab in the Prevention of Acute Graft-versus-host Disease in Unrelated Allogeneic Hematopoietic Stem Cell Transplantation Therapy for Thalassemia Major

NCT02342145 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 205

Last updated 2025-06-18

No results posted yet for this study

Summary

The purpose of this study is to evaluate the basiliximab for prevention of graft-versus-host disease in unrelated allo-genetic hematopoietic stem cell transplantation for thalassemia major. The objective was to evaluate the effect and safety of basiliximab for acute graft-versus-host disease.

Conditions

  • Beta-Thalassemia Major
  • Graft-versus-host Disease (GVHD)

Interventions

DRUG

Basiliximab,

Basiliximab was used on 0d (after transplantation) and +4d (10mg for weight under 35kg, 20mg for over 35kg) .

DRUG

Tacrolimus

Specifically Tacrolimus was used by intravenous drip infusion on 0.03mg/kg dosage from -1d and change to 0.1mg/kg oral when gastrointestinal function recovers. The blood concentrations of cyclosporine A was maintained 5-10 ng/ml.

DRUG

Methotrexate

Methotrexate was used 15mg/m2 on +1d and 10mg/m2 on +3d,+6d,+11d by intravenous for prevention of graft-versus-host-disease.

DRUG

Mycophenolate mofetil

Mycophenolate mofetil was used 0.25g per day from -1d to 90d for prevention of graft-versus-host-disease.

Sponsors & Collaborators

  • Liuzhou Workers' Hospital

    collaborator OTHER_GOV

  • Hainan General Hospital

    collaborator OTHER

  • McMaster University

    collaborator OTHER

  • Guangxi Key Laboratory of Thalassemia Research

    collaborator UNKNOWN

  • NHC Key Laboratory of Thalassemia Medicine

    collaborator UNKNOWN

  • Zhongming Zhang

    lead OTHER

Principal Investigators

  • yongrong lai, PhD · First Affiliated Hospital of Guangxi Medical University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2022-08-20
Completion
2022-08-20

Countries

  • China

Study Locations

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Entities

Drugs
Companies

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 NCT02342145 on ClinicalTrials.gov