ATG Combined With Cyclophosphamide And Cord Blood Transfusion in Treating Patients With Severe Aplastic Anemia
NCT ID: NCT02838992
Last Updated: 2017-02-01
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
PHASE4
130 participants
INTERVENTIONAL
2017-02-28
2019-07-31
Brief Summary
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Detailed Description
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The investigators have already summarized the effectiveness of rabbit antithymocyte immunoglobulin (ATG), cyclophosphamide (Cy) and cyclosporine, A (CsA) and the combination of the umbilical cord blood infusion for SAA/VSAA patients without suitable donor, with short duration, without long-term immunosuppressive therapy history. The total effectiveness rates has improved to 88%, with shorter immunosuppressive maintaining therapy , rapid hematopoietic reconstruction, fewer complications. The aim of this study is to further explore whether this solution can accelerate hematopoietic reconstruction of SAA/VSAA patients and its clinical curative effect and security. This study scheme has been approved by the Jinan military region general hospital medical ethics committee.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ATG, Cy and cord blood transfusion group
ATG 3mg/kg/d for 5 days Cy 50mg/kg/d for 2 days CSA Started from 5mg/kg/d and adjusted to maintain trough serum concentration of 200-400ng/ml One unit of cord blood having no more than 3 HLA-A,B and DRB1 mismatches is transfused 24h after last dose of ATG administration.
Intervention:
Drug: Rabbit ATG, Thymoglobuline (Genzyme) plus Cyclophosphamide plus CSA Biological: Cord blood transfusion
Rabbit ATG, (Genzyme)
ATG is an infusion of rabbit-derived antibodies against human T cells, which is used in the prevention and treatment of acute rejection in organ transplantation and therapy of aplastic anemia
Cy
Cyclophosphamide is a medication mainly used in chemotherapy. It is an alkylating agent of the nitrogen mustard type
CsA
CsA is an immunosuppressant drug widely used in organ transplantation to prevent rejection. It reduces the activity of the immune system by interfering with the activity and growth of T cells
Cord blood
Cord blood is blood that remains in the placenta and in the attached umbilical cord after childbirth. Cord blood is collected because it contains stem cells, which can be used to treat hematopoietic and genetic disorders
ATG and CSA group
ATG 3mg/kg/d for 5 days CSA started from 5mg/kg/d and adjusted to maintain trough serum concentration of 200-400ng/ml Intervention: Drug: Rabbit ATG, Thymoglobuline (Genzyme) plus CSA
Rabbit ATG, (Genzyme)
ATG is an infusion of rabbit-derived antibodies against human T cells, which is used in the prevention and treatment of acute rejection in organ transplantation and therapy of aplastic anemia
CsA
CsA is an immunosuppressant drug widely used in organ transplantation to prevent rejection. It reduces the activity of the immune system by interfering with the activity and growth of T cells
Interventions
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Rabbit ATG, (Genzyme)
ATG is an infusion of rabbit-derived antibodies against human T cells, which is used in the prevention and treatment of acute rejection in organ transplantation and therapy of aplastic anemia
Cy
Cyclophosphamide is a medication mainly used in chemotherapy. It is an alkylating agent of the nitrogen mustard type
CsA
CsA is an immunosuppressant drug widely used in organ transplantation to prevent rejection. It reduces the activity of the immune system by interfering with the activity and growth of T cells
Cord blood
Cord blood is blood that remains in the placenta and in the attached umbilical cord after childbirth. Cord blood is collected because it contains stem cells, which can be used to treat hematopoietic and genetic disorders
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of SAA and VSAA in accordance with the \<aplastic anemia, diagnosis and treatment expert consensus\> Camitta standard (see appendix 1).
3. Confirmed of heavy and very heavy aplastic anemia within 6 months.
4. No obvious abnormal liver and kidney function: ALT, AST,≤2.5 times the upper limit of normal , serum Creatinine and BUN ≤1.25 times the upper limit of normal
5. Clear understanding, voluntary to participate in the study, and signed informed consent document by the patient or the legal guardian
6. Willingness and ability to comly with the treatment plan, follow-up and laboratory tests as required
Exclusion Criteria
2. Pregnancy or breastfeeding
3. Participated in other clinical trials within three months
4. Presence of Any fatal disease, including respiratory failure, heart failure, liver or kidney failure, et al
5. Aplastic anemia caused by the treatment of other malignant tumor treatment
6. With severe mental illness
7. With other malignant tumor
8. Severe infection or the infection difficult to be controlled
9. Received ATG or cyclosporine A within six months
10. Severely allergic to biological agents
11. Any other situation judged by the investigator that the patients inappropriate for entry into this study
1 Year
60 Years
ALL
No
Sponsors
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Shandong University of Traditional Chinese Medicine
OTHER
Jining Medical University
OTHER
Weifang Medical University
OTHER
Guangzhou First People's Hospital
OTHER
Harbin Hematology and Oncology Institute
OTHER
Jining First People's Hospital
OTHER
JIANGXI Provincal People's Hospital
UNKNOWN
Jinhua Central Hospital
OTHER
Linyi People's Hospital
OTHER
Shandong Cord Blood Bank
UNKNOWN
Qingdao Hiser Medical Group
OTHER
Qingdao University
OTHER
Taian City Central Hospital
OTHER
Yantai Yuhuangding Hospital
OTHER
Yishui Central Hospital of LINYI
UNKNOWN
Institute of Hematology & Blood Diseases Hospital, China
OTHER
Shengjing Hospital
OTHER
Jinan Military General Hospital
OTHER
Responsible Party
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Fang Zhou
Principal Investigator
Principal Investigators
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Fang Zhou, MD
Role: STUDY_CHAIR
The General Hospital Of Jinan Military Command
Locations
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The General Hospital Of Jinan Military Command
Jinan, Shandong, China
Countries
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Central Contacts
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Facility Contacts
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References
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Killick SB, Bown N, Cavenagh J, Dokal I, Foukaneli T, Hill A, Hillmen P, Ireland R, Kulasekararaj A, Mufti G, Snowden JA, Samarasinghe S, Wood A, Marsh JC; British Society for Standards in Haematology. Guidelines for the diagnosis and management of adult aplastic anaemia. Br J Haematol. 2016 Jan;172(2):187-207. doi: 10.1111/bjh.13853. Epub 2015 Nov 16. No abstract available.
Zhou F, Ge L, Yu Z, Fang Y, Kong F. Clinical observations on intensive immunosuppressive therapy combined with umbilical cord blood support for the treatment of severe aplastic anemia. J Hematol Oncol. 2011 Jun 10;4:27. doi: 10.1186/1756-8722-4-27.
Xie LN, Fang Y, Yu Z, Song NX, Kong FS, Liu XM, Zhou F. Increased immunosuppressive treatment combined with unrelated umbilical cord blood infusion in children with severe aplastic anemia. Cell Immunol. 2014 May-Jun;289(1-2):150-4. doi: 10.1016/j.cellimm.2014.03.014. Epub 2014 Apr 3.
Yu Z, Zhou F, Ge LF, Liu XM, Fang Y, Xie LN, Kong FS, Song NX, Yu QQ. Mechanism of immunosuppressants combined with cord blood for severe aplastic anemia. Int J Clin Exp Med. 2015 Feb 15;8(2):2484-94. eCollection 2015.
Xie LN, Zhou F. Unexpected unrelated umbilical cord blood stem cell engraft in two patients with severe aplastic anemia that received immunosuppressive treatment: A case report and literature review. Exp Ther Med. 2015 Oct;10(4):1563-1565. doi: 10.3892/etm.2015.2698. Epub 2015 Aug 21.
Other Identifiers
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JinanMGH
Identifier Type: -
Identifier Source: org_study_id
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