Unique ID issued by UMIN | C000000354 |
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Receipt number | R000000448 |
Scientific Title | Dose finding study of Campath-1H in haploidentical HLA-mismatched hematopoietic stem cell transplantation for hematological malignancies |
Date of disclosure of the study information | 2006/03/10 |
Last modified on | 2012/09/10 13:45:06 |
Dose finding study of Campath-1H in haploidentical HLA-mismatched hematopoietic stem cell transplantation for hematological malignancies
Dose-reducing study of Campath-1H
Dose finding study of Campath-1H in haploidentical HLA-mismatched hematopoietic stem cell transplantation for hematological malignancies
Dose-reducing study of Campath-1H
Japan |
Hematological malignancies
Hematology and clinical oncology |
Malignancy
NO
To find the optimal dose of Campath-1H by stepwise dose-reduction.
Safety,Efficacy
Exploratory
Pragmatic
Phase I,II
Donor cell engraftment and the incidence of grade III to IV acute GVHD within 60 days after transplantation
Relapse rate and non-relapse mortality at 1 year
Overall survival at 1 year
Immune reconstitution
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
To find minimum tolerated dose by reducing the dose of Campath-1H with evaluation of the incidence of grade III to IV acute GVHD.
16 | years-old | <= |
65 | years-old | >= |
Male and Female
1. Patients with hematological malignancies which can not be cured without transplantation.
2. Patients who have a 2- or 3-loci-mismatched haploidentical related donor with good physical condition.
1. Patients who have an available HLA-A/B/DR-matched or 1-locus-mismatched donor in family members.
2. Patients who have an HLA-matched unrelated donor and whose disease status can wait for time-consuming donor coordination.
36
1st name | |
Middle name | |
Last name | Yoshinobu Kanda |
University of Tokyo Hospital
Department of Hematology & Oncology
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
03-3815-5411
1st name | |
Middle name | |
Last name | Yoshinobu Kanda |
University of Tokyo Hospital
Department of Hematology & Oncology
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
03-3815-5411
http://www.h.u-tokyo.ac.jp/mukin/
ycanda-tky@umin.ac.jp
University of Tokyo Hospital
None
Self funding
NO
2006 | Year | 03 | Month | 10 | Day |
Unpublished
Completed
2005 | Year | 03 | Month | 08 | Day |
2005 | Year | 04 | Month | 01 | Day |
2008 | Year | 12 | Month | 01 | Day |
2009 | Year | 12 | Month | 01 | Day |
2010 | Year | 03 | Month | 01 | Day |
2010 | Year | 05 | Month | 01 | Day |
2006 | Year | 03 | Month | 09 | Day |
2012 | Year | 09 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000448
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