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Main
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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. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000006071 |
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Date of registration:
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31/08/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Allogeneic hematopoietic stem cell transplantation for aplastic anemia using low-dose anti-thymocyte globulin
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Scientific title:
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Allogeneic hematopoietic stem cell transplantation for aplastic anemia using low-dose anti-thymocyte globulin - HSCT for AA using low-dose ATG |
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Date of first enrolment:
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2011/08/01 |
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Target sample size:
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28 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007182 |
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Study type:
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Interventional |
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Study design:
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Single arm Non-randomized
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Phase:
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Phase II
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Countries of recruitment
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Japan
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Contacts
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Name:
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Shinichiro Okamoto |
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Address:
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Tokyo
Japan |
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Telephone:
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03-6225-2040 |
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Email:
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ksgctdc@ksgct.net |
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Affiliation:
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Kanto Study Group for Cell Therapy Chairman |
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Name:
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Shinichi Kako |
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Address:
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Saitama
Japan |
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Telephone:
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048-647-2111 |
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Email:
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shinichikako@asahi-net.email.ne.jp |
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Affiliation:
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Kanto Study Group for Cell Therapy Trial Office |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: Exclusion criteria 1. Patients with poorly controlled DM 2. Patients with poorly controlled hypertension 3. Patients with poorly controlled active infection 4. Patients with chromosome 7 abnormality 5. Patients with coexistence of malignancy 6. Patients who are pregnant or nursing 7. Patients with serious mental disorder 8. Patients with HBs antigen or HBe antigen positive 9. Patients with HIV antibody positive 10. Patients who are allergic to drugs used in conditioning regimen 11. Patients who had undergone allogeneic HSCT
Age minimum:
16years-old
Age maximum:
65years-old
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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SAA
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Intervention(s)
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Conditioning regimen Fludarabine 30mg/m2/day iv day-6,-5,-4,-3 Cyclophosphamide 25mg/kg/day iv day-6,-5,-4,-3 ATG(thymoglobulin) 1.25mg/kg iv day-4,-3 In case of HSCT from unrelated donor or HLA-mismatched related donor, TBI 2Gy day-1 will be added.
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Primary Outcome(s)
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1-year overall survival
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Secondary Outcome(s)
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engraftment rate, rate of grade II-IV acute GVHD, rate of chronic GVHD, rate of mixed chimerism, rate of CMV disease, rate of PTLD
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Source(s) of Monetary Support
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None
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Ethics review
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Status: YES
Approval date: 24/06/2013
Contact:
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