Efficacy and Safety Study of 4-Day ATG Regimen for Prophylaxis of aGVHD in Matched Sibling Donor PBSCT
NCT ID: NCT05214066
Last Updated: 2022-02-22
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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UNKNOWN
PHASE2
60 participants
INTERVENTIONAL
2019-02-01
2022-08-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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4-day ATG combined regimen
ATG combined regimen for prophylaxis of GVHD, includes ATG, MMF (Mycophenolate mofetil), CsA (cyclosporin A) and MTX (methotrexate). All recipients in this arm received ATG, CsA, mycophenolate mofetil, and short-term methotrexate for GVHD prophylaxis. ATG (Thymoglobuline, rabbit) was used as 1 mg/kg/d from day -5 to day -3 and 2 mg/kg/d on day -2. CsA (3 mg/kg, q12h, i.v.) was used from day -9, and the concentration was adjusted to 180-200 ng/mL. CsA was switched to oral administration when the patient's bowel function recovered. From day -9, 0.5 g of mycophenolate mofetil was administered orally from every 12 h, which was withdrawn on day +30. After graft infusion, MTX was given for all patients at 15 mg/m2 on day +1 and 10 mg/m2 on days +3, +6 and +11.
Rabbit ATG
ATG (Thymoglobuline, rabbit) was used as 1 mg/kg/d from day -5 to day -3 and 2 mg/kg/d on day -2.
Interventions
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Rabbit ATG
ATG (Thymoglobuline, rabbit) was used as 1 mg/kg/d from day -5 to day -3 and 2 mg/kg/d on day -2.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients were diagnosed of acute leukemia or MDS;
* There were indications of MSD-PBSCT for these patients;
* Patients without any uncontrolled infections or without severe pulmonary, renal, hepatic or cardiac diseases.
Exclusion Criteria
* AML patients with t (15;17).
14 Years
65 Years
ALL
No
Sponsors
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Chinese PLA General Hospital
OTHER
Responsible Party
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Daihong Liu
Director
Principal Investigators
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Daihong Liu, Doctor
Role: STUDY_DIRECTOR
Chinese PLA General Hospital
Locations
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Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Nan Bai
Role: primary
Other Identifiers
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81370667
Identifier Type: -
Identifier Source: org_study_id
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