Unique ID issued by UMIN | UMIN000011946 |
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Receipt number | R000013952 |
Scientific Title | A Phase II Study of Chemotherapy Combined with Tyrosine Kinase Inhibitors for Children with Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (JPLSG ALL-Ph13). |
Date of disclosure of the study information | 2013/10/02 |
Last modified on | 2019/10/07 09:40:16 |
A Phase II Study of Chemotherapy Combined with Tyrosine Kinase Inhibitors for Children with Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (JPLSG ALL-Ph13).
A Phase II Study of Chemotherapy with TKI for Children with Ph+ALL (JPLSG ALL-Ph13).
A Phase II Study of Chemotherapy Combined with Tyrosine Kinase Inhibitors for Children with Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (JPLSG ALL-Ph13).
A Phase II Study of Chemotherapy with TKI for Children with Ph+ALL (JPLSG ALL-Ph13).
Japan |
Childhood Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
Hematology and clinical oncology | Pediatrics | Child |
Malignancy
NO
To assess a efficacy and safety of a BFM2000 HR backbone chemotherapy combined with tyrosine kinase inhibitor for childhood Philadelphia positive acute lymphoblastic leukemia in Japan.
Safety,Efficacy
Three years event free survival
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Chemotherapy combined with imatinib or dasatinib.
1 | years-old | <= |
19 | years-old | >= |
Male and Female
1) diagnosis of Ph+ALL
2) age between 1 and 19 years old
3) ECOG performance status (PS) score of 0-3
4) no history of previous chemotherapy or radiation therapy
5) written informed consent obtained from
patient or guardians.
1) uncontrolled infection, including active tuberculosis and positive of HIV antibody.
2) pregnancy or high possibility of pregnancy and giving suck wiman.
3) history of congenital or acquired immunodeficiency.
4) any inappropriate status judged by
physician.
44
1st name | Hirohide |
Middle name | |
Last name | Kawasaki |
Kansai Medical University
Department of Pediatrics
573-1010
2-5-1 Shinmachi, Hirakata, Osaka
072-804-0101
kawasaki@hirakata.kmu.ac.jp
1st name | Hirohide |
Middle name | |
Last name | Kawasaki |
Kansai Medical University
Department of Pediatrics
573-1010
2-5-1 Shinmachi, Hirakata, Osaka
072-804-0101
kawasaki@hirakata.kmu.ac.jp
Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG)
Ministry of Health, Labour and Welfare
Non profit foundation
Japan
Kansai Medical University
Department of Pediatrics
072-804-0101
kawasaki@hirakata.kmu.ac.jp
NO
2013 | Year | 10 | Month | 02 | Day |
Unpublished
Open public recruiting
2013 | Year | 10 | Month | 01 | Day |
2013 | Year | 10 | Month | 01 | Day |
2013 | Year | 10 | Month | 02 | Day |
2019 | Year | 10 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013952
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