Hematopoietic Stem Cell Transplantation for Patients With Thalassemia Major: A Multicenter, Prospective Clinical Study
NCT ID: NCT04009525
Last Updated: 2024-08-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
823 participants
INTERVENTIONAL
2019-07-05
2023-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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MSD-HSCT
matched sibling donors hematopoietic stem cell transplantation
Busulfan
Busulfan（4 mg/kg/day,4 days）
Cyclophosphamide
Cyclophosphamide（50 mg/kg/day,4 days）
Fludarabine
Fludarabine（50 mg/m2/day,3 days）
Thymoglobulin
Thymoglobulin（2.5 mg/kg/day,4 days）
cyclosporine A
cyclosporine A
Mycophenolate mofetil
Mycophenolate mofetil（0.25g/day）
Methotrexate
Methotrexate
URD-HSCT
unrelated donor hematopoietic stem cell transplantation
Busulfan
Busulfan（4 mg/kg/day,4 days）
Cyclophosphamide
Cyclophosphamide（50 mg/kg/day,4 days）
Fludarabine
Fludarabine（50 mg/m2/day,3 days）
Thymoglobulin
Thymoglobulin（2.5 mg/kg/day,4 days）
Mycophenolate mofetil
Mycophenolate mofetil（0.25g/day）
Tacrolimus
Tacrolimus
Methotrexate
Methotrexate
haplo-HSCT
haplo-identical hematopoietic stem cell transplantation
Busulfan
Busulfan（4 mg/kg/day,4 days）
Cyclophosphamide
Cyclophosphamide（50 mg/kg/day,4 days）
Fludarabine
Fludarabine（50 mg/m2/day,3 days）
Thymoglobulin
Thymoglobulin（2.5 mg/kg/day,4 days）
Mycophenolate mofetil
Mycophenolate mofetil（0.25g/day）
Tacrolimus
Tacrolimus
Methotrexate
Methotrexate
Interventions
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Busulfan
Busulfan（4 mg/kg/day,4 days）
Cyclophosphamide
Cyclophosphamide（50 mg/kg/day,4 days）
Fludarabine
Fludarabine（50 mg/m2/day,3 days）
Thymoglobulin
Thymoglobulin（2.5 mg/kg/day,4 days）
cyclosporine A
cyclosporine A
Mycophenolate mofetil
Mycophenolate mofetil（0.25g/day）
Tacrolimus
Tacrolimus
Methotrexate
Methotrexate
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Indication of hematopoietic stem cell transplantation.
3. A cardiac ejection fraction of \>50%; normal pulmonary function tests and pulmonary examination results; and normal kidney function.
Exclusion Criteria
2. Uncontrolled bacterial, viral or fungal infections;
3. Any other restriction for transplantation.
2 Years
20 Years
ALL
No
Sponsors
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Peking University People's Hospital
OTHER
Ruijin Hospital
OTHER
The 923rd Hospital of Joint Logistics Support Force of People's Liberation Army
OTHER
LiuZhou People's Hospital
OTHER
The First People's Hospital of Yunnan
OTHER
Liuzhou Workers' Hospital
OTHER_GOV
Xinqiao Hospital of Chongqing
OTHER
Affiliated Hospital of Youjiang University of Ethnic Medicine
UNKNOWN
Hainan People's Hospital
OTHER
Maoming People's Hospital
OTHER
Red Cross Hospital of Yulin City
OTHER
Guilin Medical College
OTHER
Wuzhou People's Hospital
UNKNOWN
Guangxi Autonomous Region People's Hospital
UNKNOWN
The 920th Hospital of Joint Logistics Support Force of People's Liberation Army
UNKNOWN
First Affiliated Hospital of Guangxi Medical University
OTHER
Responsible Party
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Yongrong Lai
Director of the Hematology Department
Principal Investigators
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Yongrong Lai, MD
Role: PRINCIPAL_INVESTIGATOR
First Affiliated Hospital of Guangxi Medical University
Locations
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First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
Countries
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Other Identifiers
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GX-HSCT-MT 2019
Identifier Type: -
Identifier Source: org_study_id
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