Haploidentical Hematopoietic Stem Cell Transplantation for Patients With Thalassemia Major
NCT03171831 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2017-05-31
Summary
The purpose of the study is to assess the safety and efficacy of haploidentical hematopoietic stem cell transplantation for patients with 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
-
Mycophenolate mofetil
Mycophenolate mofetil(0.25g/day)
- DRUG
-
Tacrolimus(0.03mg/kg/day)
- DRUG
-
Methotrexate
Methotrexate(15mg/m2 on day +1,10mg/m2 on day +3,+6,+11)
- DRUG
-
Thymoglobulin
Thymoglobulin(2.5 mg/kg/day,4 days)
- DRUG
-
Basiliximab
Basiliximab(10mg on day 0 and +4)
Sponsors & Collaborators
-
First Affiliated Hospital of Guangxi Medical University
lead OTHER
Principal Investigators
-
Yongrong Lai, MD · First Affiliated Hospital of Guangxi Medical University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 2 Years
- Max Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-04-01
- Primary Completion
- 2021-12-31
- Completion
- 2022-04-01
Countries
- China
Study Locations
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