Dose Study of Antithymocyteglobulin in Haploidentical Allogeneic Stem Cell Transplantation
NCT ID: NCT02643589
Last Updated: 2015-12-31
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
NA
200 participants
INTERVENTIONAL
2013-06-30
2016-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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ATG 7.5mg/kg
ATG 7.5mg/kg group refers to treatment with ATG in the total dose of 7.5mg/kg.
ATG
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.
ATG 10mg/kg
ATG 10mg/kg group refers to treatment with ATG in the total dose of 10mg/kg.
ATG
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.
Interventions
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ATG
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Patients with any conditions not suitable for the trial (investigators' decision)
14 Years
65 Years
ALL
No
Sponsors
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Peking University People's Hospital
OTHER
Central South University Xiangya Hospital
UNKNOWN
Fujian Medical University
OTHER
Nanfang Hospital, Southern Medical University
OTHER
Responsible Party
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Qifa Liu
Professor
Principal Investigators
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Qifa Liu
Role: PRINCIPAL_INVESTIGATOR
Nanfang Hospital, Southern Medical University
Locations
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Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Ren Lin
Role: primary
References
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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.
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.
Other Identifiers
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NFEC-201304-K1(02)
Identifier Type: -
Identifier Source: org_study_id