Dose Study of Antithymocyteglobulin in Haploidentical Allogeneic Stem Cell Transplantation
1 other identifier
interventional
200
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 29, 2015
CompletedFirst Posted
Study publicly available on registry
December 31, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedDecember 31, 2015
December 1, 2015
3 years
December 29, 2015
December 30, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of acute GVHD
Acute GVHD was graded according to standard criteria.
1 years
Secondary Outcomes (2)
Immune reconstitution
3 years
Survival
3 years
Study Arms (2)
ATG 7.5mg/kg
EXPERIMENTALATG 7.5mg/kg group refers to treatment with ATG in the total dose of 7.5mg/kg.
ATG 10mg/kg
ACTIVE COMPARATORATG 10mg/kg group refers to treatment with ATG in the total dose of 10mg/kg.
Interventions
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
You may qualify if:
- Haploidentical hematopoietic stem cell 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nanfang Hospital, Southern Medical Universitylead
- Peking University People's Hospitalcollaborator
- Central South University Xiangya Hospitalcollaborator
- Fujian Medical Universitycollaborator
Study Sites (1)
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515, China
Related Publications (2)
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.
PMID: 12689945BACKGROUNDBacigalupo 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.
PMID: 11698275BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Qifa Liu
Nanfang Hospital, Southern Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 29, 2015
First Posted
December 31, 2015
Study Start
June 1, 2013
Primary Completion
June 1, 2016
Study Completion
December 1, 2016
Last Updated
December 31, 2015
Record last verified: 2015-12