Comparison of Different Dose of Anti-T Lymphocyte Globulin (ATLG) in Haploidentical HSCT for GVHD Prophylaxis
NCT ID: NCT06525519
Last Updated: 2024-07-29
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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NOT_YET_RECRUITING
PHASE3
104 participants
INTERVENTIONAL
2024-07-31
2026-07-31
Brief Summary
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Detailed Description
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Several European studies have shown that a dose of 30mg/kg of ATLG can effectively prevent GVHD with acceptable safety. But, the most commonly reported dose among Chinese population is 20mg/kg. Additionally, the main type of allo-HSCT in China is haploidentical transplantation. The application experience of ATLG in Europe mainly focuses on sibling and unrelated donor transplants. There is still a lack of sufficient exploration on the optimal dose of ATLG in GVHD prevention in haploidentical transplantation.
In this prospective multiple-center randomized trial, we aim to compare the effects of different doses of ATLG on GVHD prevention, risk of viral infection, and patient survival after haploidentical transplantation.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ATLG-20 mg/kg
ATLG 20mg/kg group refers to treatment with ATLG in the total dose of 20mg/kg.
ATLG
5 mg/kg/day IV for 4 consecutive days (day-5 to -2 before transplantation). All transplant recipients will receive myeloablative conditioning or modified myoloablative conditioning and standard GVHD prophylaxis.
ATLG-30mg/kg
ATLG 30mg/kg group refers to treatment with ATLG in the total dose of 30mg/kg.
ATLG
7.5mg/kg/day IV for 4 consecutive days (day-5 to -2 before transplantation). All transplant recipients will receive myeloablative conditioning or modified myoloablative conditioning and standard GVHD prophylaxis.
Interventions
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ATLG
5 mg/kg/day IV for 4 consecutive days (day-5 to -2 before transplantation). All transplant recipients will receive myeloablative conditioning or modified myoloablative conditioning and standard GVHD prophylaxis.
ATLG
7.5mg/kg/day IV for 4 consecutive days (day-5 to -2 before transplantation). All transplant recipients will receive myeloablative conditioning or modified myoloablative conditioning and standard GVHD prophylaxis.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
16 Years
65 Years
ALL
No
Sponsors
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Institute of Hematology & Blood Diseases Hospital, China
OTHER
Responsible Party
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Locations
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The Southwest Hospital of Amu
Chongqing, Chongqing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
The First Bethune Hospital of Jilin University
Jilin, Jilin, China
Tai'an City Central Hospital
Taian, Shandong, China
People's Liberation Army The General Hospital of Western Theater Command
Chengdu, Sichuan, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IIT2024027
Identifier Type: -
Identifier Source: org_study_id
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