Hematopoietic Stem Cell Transplantation for Patients With Thalassemia Major: A Multicenter, Prospective Clinical Study
NCT04009525 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 823
Last updated 2024-08-09
Summary
The only curative therapy for thalassemia major remains the replacement of the defective erythropoiesis by allogeneic hematopoietic stem cell transplantation(allo-HSCT). We conduct a prospective multicenter study to evaluate the efficacy of allo-HSCT in the treatment of thalassemia major.
Conditions
- Thalassemia Major
Interventions
- DRUG
-
Busulfan
Busulfan（4 mg/kg/day,4 days）
- DRUG
-
Cyclophosphamide（50 mg/kg/day,4 days）
- DRUG
-
Fludarabine（50 mg/m2/day,3 days）
- DRUG
-
Thymoglobulin
Thymoglobulin（2.5 mg/kg/day,4 days）
- DRUG
-
cyclosporine A
cyclosporine A
- DRUG
-
Mycophenolate mofetil
Mycophenolate mofetil（0.25g/day）
- DRUG
-
Tacrolimus
- DRUG
-
Methotrexate
Methotrexate
Sponsors & Collaborators
-
Peking University People's Hospital
collaborator OTHER -
Ruijin Hospital
collaborator OTHER -
The 923rd Hospital of Joint Logistics Support Force of People's Liberation Army
collaborator OTHER -
LiuZhou People's Hospital
collaborator OTHER -
The First People's Hospital of Yunnan
collaborator OTHER -
Liuzhou Workers' Hospital
collaborator OTHER_GOV -
Xinqiao Hospital of Chongqing
collaborator OTHER -
Affiliated Hospital of Youjiang University of Ethnic Medicine
collaborator UNKNOWN -
Hainan People's Hospital
collaborator OTHER -
Maoming People's Hospital
collaborator OTHER -
Red Cross Hospital of Yulin City
collaborator OTHER -
Guilin Medical College
collaborator OTHER -
Wuzhou People's Hospital
collaborator UNKNOWN -
Guangxi Autonomous Region People's Hospital
collaborator UNKNOWN -
The 920th Hospital of Joint Logistics Support Force of People's Liberation Army
collaborator UNKNOWN -
First Affiliated Hospital of Guangxi Medical University
lead OTHER
Principal Investigators
-
Yongrong Lai, MD · First Affiliated Hospital of Guangxi Medical University
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 2 Years
- Max Age
- 20 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-07-05
- Primary Completion
- 2023-07-31
- Completion
- 2023-10-31
Countries
- China
Study Locations
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