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| Name | Class |
|---|---|
| Peking University People's Hospital | OTHER |
| Central South University Xiangya Hospital | UNKNOWN |
| Fujian Medical University | OTHER |
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The purpose of this study is to compare the incidences of GVHD in haploidentical hematopoietic stem cell transplant recipients receiving different dose of antithymocyte globulin (ATG) for acute graft-versus-host disease(aGVHD) prophylaxis. The investigators' first objective was to investigate the optimal dose of ATG for aGVHD.
Graft-versus-host diseases (GVHD) remains a major cause of morbility and mortality after allogeneic hematopoietic stem cell transplantation (HSCT) with grafts from an HLA-mismatched family donor. Antithymocyteglobulin (ATG) has been widely used to prevent acute GVHD (aGVHD) in haploidentical HSCT. Notwithstanding, immunosuppressive effect of ATG, which may also increase the risk of opportunistic infections, necessitates the use of the lowest possible dose. Till now, the optimal dose of ATG is not known. Here, the investigators compared the outcome of patients receiving haploidentical HSCT treated with two different doses of ATG.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ATG 7.5mg/kg | Experimental | ATG 7.5mg/kg group refers to treatment with ATG in the total dose of 7.5mg/kg. |
|
| ATG 10mg/kg | Active Comparator | ATG 10mg/kg group refers to treatment with ATG in the total dose of 10mg/kg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ATG | Drug | ATG will be intravenously infused via a central venous catheter in 3 or 4 days, from day -4 or -3 until day 0. The other conditioning drugs administered before transplantation include cytosine arabinoside (Ara-C), busulfan (Bu),cyclophosphamide (Cy), Semustine(Me-CCNU), and ATG. All transplant recipients will receive cyclosporine A (CsA), mycophenolate mofetil(MMF), and short-term methotrexate for aGVHD prevention. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of acute GVHD | Acute GVHD was graded according to standard criteria. | 1 years |
| Measure | Description | Time Frame |
|---|---|---|
| Immune reconstitution | Immune reconstitution is performed every 3 months after transplantation. | 3 years |
| Survival | Survival includes overall and disease-free survival within 2 years after transplantation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ren Lin | Contact | +86-020-62787883 | lansinglinren@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Qifa Liu | Nanfang Hospital, Southern Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanfang Hospital, Southern Medical University | Recruiting | Guangzhou | Guangdong | 510515 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12689945 | Background | Ottinger HD, Ferencik S, Beelen DW, Lindemann M, Peceny R, Elmaagacli AH, Husing J, Grosse-Wilde H. Hematopoietic stem cell transplantation: contrasting the outcome of transplantations from HLA-identical siblings, partially HLA-mismatched related donors, and HLA-matched unrelated donors. Blood. 2003 Aug 1;102(3):1131-7. doi: 10.1182/blood-2002-09-2866. Epub 2003 Apr 10. | |
| 11698275 |
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| 3 years |
| Background |
| Bacigalupo A, Lamparelli T, Bruzzi P, Guidi S, Alessandrino PE, di Bartolomeo P, Oneto R, Bruno B, Barbanti M, Sacchi N, Van Lint MT, Bosi A. Antithymocyte globulin for graft-versus-host disease prophylaxis in transplants from unrelated donors: 2 randomized studies from Gruppo Italiano Trapianti Midollo Osseo (GITMO). Blood. 2001 Nov 15;98(10):2942-7. doi: 10.1182/blood.v98.10.2942. |