|
Main
|
|
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:
|
JPRN |
|
Last refreshed on:
|
17 October 2023 |
|
Main ID: |
JPRN-C000000356 |
|
Date of registration:
|
20/03/2006 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Evaluation of the safety and efficacy of allogeneic hematopoietic stem cell transplantation (HSCT) using alemtuzumab for patients with aplastic anemia
|
|
Scientific title:
|
Evaluation of the safety and efficacy of allogeneic hematopoietic stem cell transplantation (HSCT) using alemtuzumab for patients with aplastic anemia - HSCT for aplastic anemia using alemtuzumab |
|
Date of first enrolment:
|
2004/12/01 |
|
Target sample size:
|
38 |
|
Recruitment status: |
Complete: follow-up complete |
|
URL:
|
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000453 |
|
Study type:
|
Interventional |
|
Study design:
|
Single arm Non-randomized
|
|
Phase:
|
Phase I,II
|
|
|
Countries of recruitment
|
|
Japan
| | | | | | | |
|
Contacts
|
|
Name:
|
Yoshinobu Kanda |
|
Address:
|
7-3-1 Hongo,Bunkyo-ku, Tokyo
Japan |
|
Telephone:
|
03-3815-5411 |
|
Email:
|
ycanda-tky@umin.ac.jp |
|
Affiliation:
|
The University of Tokyo Hospital Department of Hematology & Oncology |
|
|
Name:
|
Shuichi Taniguchi |
|
Address:
|
2-2-2 Toranomon, Minato-ku,
Japan |
|
Telephone:
|
03-3588-1111 |
|
Email:
|
|
|
Affiliation:
|
Federation of National Public Service Personnel Mutual Aid Association Toranomon Hospital Department of Hematology |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria:
Exclusion criteria: (1) Diabetes uncontrollable even with regular insulin use. (2) Uncontrollable hypertension. (3) Current active infection. (4) 5% or more malignant cell involvement in bone marrow. (5) Abnormality in chromosome 7 detected by bone marrow G-banding or FISH. (6) Current active cancer. (7) Pregnant or nursing women or women who may be pregnant. (8) Uncontrollable mental illness. (9) Hepatitis B virus antigen-positive (HBsAg or HBeAg). (10) HIV-positive. (11) A history of hypersensitivity to transplant conditioning agents (fludarabine phosphate, cyclophosphamide) or agents for GVHD prophylaxis (ciclosporin, methotrexate). (12) A history of hematopoietic stem cell transplantation.
Age minimum:
20years-old
Age maximum:
65years-old
Gender:
Male and Female
|
|
Health Condition(s) or Problem(s) studied
|
|
Aplastic anemia
|
|
Intervention(s)
|
|
Alemtuzumab is added to the fludarabine-based regimen at 0.16 – 0.25 mg/kg per day for 6 days (days -10 to -5).
|
|
Primary Outcome(s)
|
|
Survival on day 60 after transplantation Engraftment within 60 days Incidence of grade II to IV acute GVHD within 60 days
|
|
Secondary Outcome(s)
|
|
• Regimen-related toxicity • Incidence of infectious disease • Overall survival at day 365 • Therapeutic efficacy for aplastic anemia
|
|
Source(s) of Monetary Support
|
|
2004 Health and Labor Sciences Research Grant (Research on Measures for Intractable Diseases) of the Ministry of Health, Labor and Welfare.
|
|
Ethics review
|
Status: YES
Approval date:
Contact:
|
|
Results
|
|
Results available:
|
Yes |
|
Date Posted:
|
|
|
Date Completed:
|
01/07/2009 |
|
URL:
|
|
|
|