Unique ID issued by UMIN | UMIN000010619 |
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Receipt number | R000012415 |
Scientific Title | Phase II study of multi-agent chemotherapy in patients with adult Philadelphia chromosome negative precursor B acute lymphoblastic leukemia. |
Date of disclosure of the study information | 2013/05/15 |
Last modified on | 2020/05/07 15:06:54 |
Phase II study of multi-agent chemotherapy in patients with adult Philadelphia chromosome negative precursor B acute lymphoblastic leukemia.
Study of multi-agent chemotherapy in patients with adult Philadelphia chromosome negative precursor B acute lymphoblastic leukemia. (JALSG Ph(-)B-ALL213)
Phase II study of multi-agent chemotherapy in patients with adult Philadelphia chromosome negative precursor B acute lymphoblastic leukemia.
Study of multi-agent chemotherapy in patients with adult Philadelphia chromosome negative precursor B acute lymphoblastic leukemia. (JALSG Ph(-)B-ALL213)
Japan |
Philadelphia chromosome negative precursor B acute lymphoblastic leukemia
Hematology and clinical oncology |
Malignancy
YES
To evaluate safety and efficacy of pediatric like protocols, which have a more intense use of agents such as L-asparaginase and steroids, as well as to clarify the relationship between prognosis and steroid reactivity in the treatment of newly diagnosed previously untreated adult Philadelphia chromosome negative precursor B acute lymphoblastic leukemia.
Safety,Efficacy
Phase II
3 year event free survival (EFS)
Complete remission rate
Adverse event rate
3 year overall survival (OS), and relapse free survival (RFS)
Efficacy and safety of hematopoietic stem cell transplantation such as treatment related mortality, relapse, engraftment, acute graft versus host disease (GVHD), and chronic GVHD
Relationship between initial steroid reactivity (Blast rates of bone marrow on Day 15) and prognosis such as OS, EFS and RFS
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
Induction therapy, Consolidation therapy, Maintenance therapy
15 | years-old | <= |
65 | years-old | > |
Male and Female
1. Recognized ALL
2. Precursor B-ALL (diagnosed by WHO Classification)
3. Age 15 to 64
4. Performance Status: 0 to 3
5. Adequate hepatic, renal and cardiac function
6. Written informed consent
1. Previously treated with leukapheresis
2. Congestive heart failure
3. Recent history of myocardial infarction
4. Malignant hypertension
5. Lung fibrosis
6. Interstitial pneumonitis
7. Severe comorbidity
(diabetes mellitus, infection or liver cirrhosis)
8. Positive anti-HIV antibody or HBs antigen
9. Thrombosis which need treatment
10. Psychological disorders
11. Other active neoplasms
12. Pregnant and/or lactating woman
13. Judged to be inadequate
160
1st name | Yoshihiro |
Middle name | |
Last name | Hatta |
JALSG-ALL213 research secretariat
Hematology and Rheumatology, Nixon University School of Medicine
173-8610
30-1 Okaguchi Kami-cho, Itabashi-ku, Tokyo
03-3972-8111
hatta.yoshihiro@nihon-u.ac.jp
1st name | Yoshihiro |
Middle name | |
Last name | Hatta |
JALSG-ALL213 research secretariat
Hematology and Rheumatology, Nixon University School of Medicine
173-8610
30-1 Okaguchi Kami-cho, Itabashi-ku, Tokyo
03-3972-8111
http://www.jalsg.jp
hatta.yoshihiro@nihon-u.ac.jp
Japan Adult Leukemia Study Group
Japan Agency for Medical Research and Deveopment
Japanese Governmental office
Japan
Sapporo Hokuyu Hospital, IRB
6-6-5-1 Higashi-Sapporo, Shiroishi-ku, Sappro
011-865-0111
iso.hokuyu@gmail.com
NO
2013 | Year | 05 | Month | 15 | Day |
Unpublished
211
Completed
2013 | Year | 03 | Month | 09 | Day |
2013 | Year | 04 | Month | 22 | Day |
2013 | Year | 07 | Month | 07 | Day |
2020 | Year | 06 | Month | 02 | Day |
2020 | Year | 10 | Month | 02 | Day |
2021 | Year | 02 | Month | 02 | Day |
2021 | Year | 06 | Month | 02 | Day |
2013 | Year | 04 | Month | 30 | Day |
2020 | Year | 05 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012415
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