Overview

ATG Combined With Cyclophosphamide And Cord Blood Transfusion in Treating Patients With Severe Aplastic Anemia

Status:
Unknown status
Trial end date:
2019-07-01
Target enrollment:
0
Participant gender:
All
Summary
To assess whether ATG Combined With Cyclophosphamide and cord blood infusion can accelerate hematopoietic reconstruction in severe aplastic anemia patients and improve clinical curative effect and safety
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Jinan Military General Hospital
Collaborators:
Affiliated Hospital of Weifang Medical University
Cancer Hospital of Henan Province
Guangzhou First People's Hospital
Harbin Hematology and Oncology Institute
Institute of Hematology & Blood Diseases Hospital
JIANGXI Provincal People's Hospital
Jinhua Central Hospital
Jining Medical University
Jining No.1 People`s Hospital
Liaocheng People's Hospital
Linyi People's Hospital
Qingdao Hiser Medical Group
Qingdao University
Shandong Cord Blood Bank
Shandong Jining No.1 People's Hospital
Shandong University of Traditional Chinese Medicine
Shengjing Hospital
Taian City Central Hospital
The First Affiliated Hospital of Xiamen University
Weifang Medical University
Yantai Yuhuangding Hospital
Yishui Central Hospital of LINYI
Zhangzhou Municipal Hospital of Fujian Province
Zhongshan Hospital Xiamen University
Treatments:
Cyclophosphamide
Cyclosporine
Cyclosporins
Immunosuppressive Agents
Thymoglobulin
Criteria
Inclusion Criteria:

1. Male or female ,under the age of 60.

2. Diagnosis of SAA and VSAA in accordance with the 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:

1. Congenital aplastic anemia

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