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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ChiCTR
Last refreshed on: 9 October 2017
Main ID:  ChiCTR-ONC-17012896
Date of registration: 2017-10-07
Prospective Registration: Yes
Primary sponsor: Xiangya Hosptial of Central South University
Public title: Haploidentical Stem Cell Transplantation with Post-Transplant Cyclophosphamide Combined with Short-Term Methotrexate for Severe Aplastic Anemia
Scientific title: Haploidentical Stem Cell Transplantation with Post-Transplant Cyclophosphamide Combined with Short-Term Methotrexate for Severe Aplastic Anemia:a multicenter, prospective, open-label, single-arm II/III phase study
Date of first enrolment: 2017-10-01
Target sample size: Case series:30;
Recruitment status: Recruiting
URL:  http://www.chictr.org.cn/showproj.aspx?proj=22056
Study type:  Observational study
Study design:  Case series  
Phase:  New Treatment Measure Clinical Study
Countries of recruitment
China
Contacts
Name: Bin Fu   
Address:  87 Xiangya Road, Changsha, Hu'nan, China
Telephone: +86 0731 89753731
Email: xyfubin@126.com
Affiliation:  Xiangya Hosptial of Central South University
Name: Bin Fu   
Address:  87 Xiangya Road, Changsha, Hu'nan, China
Telephone: +86 0731 89753731
Email: xyfubin@126.com
Affiliation:  Xiangya Hosptial of Central South University
Key inclusion & exclusion criteria
Inclusion criteria: 1. aged 2 to 65 years (including 2 and 65 years);
2. severe aplastic anemia or transplansion dependant aplastic anemia by Camitta criteria;
3. No HLA matched sibling or unrelated donor,or requiring prompt transplantation without finding HLA consistent donor opportunities;
4. sign informed consent.

Exclusion criteria: 1. The physical fitness score is less than 70 points;
2. HCT specificity prognostic index (HCT-CT) was greater than 4 (including 4 points);
3. uncontrolled viral, bacterial, and fungal infections (progression of disease during antifungal therapy);
4. HIV seropositive;
5. malignant tumor;
6. pregnant and lactating women;
7. men and women who do not agree to contraception during the trial period;
8. researchers believe that patients are not eligible for clinical trials.


Age minimum: 2
Age maximum: 65
Gender: Both
Health Condition(s) or Problem(s) studied
Aplastic Anemia
Intervention(s)
Case series:Post-Transplant Cyclophosphamide Combined with Short-Term Methotrexate;
Primary Outcome(s)
over survival;
Secondary Outcome(s)
Rate of aGVHD;Incidence of regimen-related mortality;incidence of chronic GVHD;Sustained engraftment;
Secondary ID(s)
Source(s) of Monetary Support
Researchers
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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