ATG in HLA-matched Sibling HSCT as GVHD Prophylaxis

Study Overview
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Brief Summary
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The protocols including ciclosporin A （CsA）+methotrexate (MTX) +mycophenolate Mofetil(MMF) have been widely used for graft-versus-host disease (GVHD) prophylaxis in allogeneic hematopoietic stem cell transplantation from HLA-matched sibling donor (MSD). Nevertheless, severe chronic graft-versus-host disease (cGVHD) remains an obstacle for MSD HSCT. A growing body of studies have suggested antithymocyte globulin (ATG) could reduce the incidence of cGVHD. This study is aim to evaluate the efficacy of a protocol that includes CsA, MTX, MMF and ATG in recipients of MSD HSCT.

Official Title
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ATG Used in Allogeneic Hematopoietic Stem Cell Transplantation From HLA-matched Sibling Donor as GVHD Prophylaxis

Conditions
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Hematopoietic Stem Cell Transplantation

Intervention / Treatment
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* Drug: ATG
* Drug: CsA
* Drug: MTX
* Drug: MMF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A patient age of 18-65 years MSD transplant recipient Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study Exclusion Criteria: Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure) Patients with any conditions not suitable for the trial (investigators' decision)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ATG group<br>ATG group refers to treatment with a protocol including low-dose ATG, CsA, short-term MTX and MMF as GVHD prophylaxis. | Drug: ATG<br>* In ATG group, ATG will be intravenously infused via a central venous catheter in day -1 at a dose of 2.5mg/kg.<br>Drug: CsA<br>* In both groups, CsA will be intravenously infused from day -9 and the dose was adjusted based on the concentration.<br>Drug: MTX<br>* In both groups, MTX will be intravenously on days +1(15mg), +3(10mg) and +6(10mg).<br>Drug: MMF<br>* In both groups, MMF will be administrated at a dose of 1.0g/d.<br>|
| Active Comparator: non-ATG group<br>Non-ATG group refers to treatment with a protocol including CsA, short-term MTX and MMF as GVHD prophylaxis. | Drug: CsA<br>* In both groups, CsA will be intravenously infused from day -9 and the dose was adjusted based on the concentration.<br>Drug: MTX<br>* In both groups, MTX will be intravenously on days +1(15mg), +3(10mg) and +6(10mg).<br>Drug: MMF<br>* In both groups, MMF will be administrated at a dose of 1.0g/d.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the incidence of cGVHD | cGVHD was graded as limited or extensive. | 2 year posttransplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | 2 year posttransplantation | 
| disease-free survival |  | 2 year posttransplantation | 
| the incidence of aGVHD | aGVHD was defined according to the 1994 Consensus Conference on Acute GVHD Grading and graded from I to IV. | 100 days 1 year posttransplantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hematopoietic Stem Cell Transplantation, antithymocyte globulin, graft-versus-host disease