CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 205 enrolled
Drug / intervention
Basiliximab, +3 moredrug
Likely dose
Basiliximab, 10mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02342145
NCT02342145Phase 4Completed
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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 Treatment: a Multi-center, Open, Randomized, Controlled Clinical Study

Zhongming Zhang·interventional·Posted Jan 19, 2015·Updated Jun 18, 2025

In Brief

A Phase 4 clinical trial evaluating Basiliximab,, Tacrolimus, and 2 other interventions for Beta-Thalassemia Major and Graft-versus-host Disease (GVHD). Completed, enrolled 205 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBeta-Thalassemia Major, Graft-versus-host Disease (GVHD)
CountriesChina
CollaboratorsLiuzhou Workers' Hospital, Hainan General Hospital, McMaster University, Guangxi Key Laboratory of Thalassemia Research, NHC Key Laboratory of Thalassemia Medicine

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJan 19, 2015
Enrollment StartApr 1, 2015
Primary CompletionAug 20, 2022
TodayJul 2, 2026
Enrollment to primary: 7.4 yearsPosted 11.5 years ago

Interventions

Basiliximab,drug

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

Tacrolimusdrug

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.

Methotrexatedrug

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

Mycophenolate mofetildrug

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