Unique ID issued by UMIN | UMIN000021553 |
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Receipt number | R000024460 |
Scientific Title | CA-GO therapy for eldery patients with 1st relapsed or primary refractory CD33-positive acute myelogenous leukemia. |
Date of disclosure of the study information | 2016/03/21 |
Last modified on | 2020/03/27 09:51:20 |
CA-GO therapy for eldery patients with 1st relapsed or primary refractory CD33-positive acute myelogenous leukemia.
CA-GO therapy for eldery patients with 1st relapsed or primary refractory CD33-positive acute myelogenous leukemia(CA-GO2015).
CA-GO therapy for eldery patients with 1st relapsed or primary refractory CD33-positive acute myelogenous leukemia.
CA-GO therapy for eldery patients with 1st relapsed or primary refractory CD33-positive acute myelogenous leukemia(CA-GO2015).
Japan |
CD33 positive, primary refractory or 1st relapse AML without APL.
Hematology and clinical oncology |
Malignancy
NO
Evaluate efficacy and safety of CA-GO therapy.
Safety,Efficacy
Confirmatory
Pragmatic
Phase II
CR rate on day43.
Rate of adverse events, OS, EFS, DFS, CR rate after 2nd CA-GO therapy, karyotype, WT1 mRNA, surface marker.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
(CA-GO therapy)
Ara-C : 10mg/m^2/12h, sc, day1 - 14
ACR :
65 -69 years : 14mg/m^2/day
70 - years : 10mg/m^2/day
1 hour, div, day1 - 4(, 8 - 10)
GO(gemtuzumab ozogamicin) : 3mg/m^2/day, 2 hour, div, day15
65 | years-old | <= |
Not applicable |
Male and Female
(1)CD33 positive, primary refractory or 1st relapse AML(non APL).
(2)Patient who has the registrar's written consent.
(3)PS 0, 1, 2
(4)T-B <2.0mg/dl
(5)Cre <2.0mg/dl
(6)PaO2 >60Torr or SpO2 >93%
(7)normal ECG and normal UCG(EF >50%)
(8)WBC <30,000 x10^6/L
(1)active other malignancy.
(2)cardiac infarction in one year.
(3)renal failure
(4)uncontrolable diabetes
(5)uncontrolable infection
(6)liver cirrhosis
(7)severe mental disorders
(8)pregnancy
(9)HIV positive
(10)allergy of GO
(11)recieved therapy include GO
(12)after SCT or solid organ transplantation
20
1st name | Wataru |
Middle name | |
Last name | TAKAHASHI |
Dokkyo medical university hospital
Hematology and Oncology
321-0293
880 Kita-Kobayashi, Mibu-machi, Shimotsuga-gun Tochigi 321-0293, JAPAN
+81-282-86-1111
twataru@dokkyomed.ac.jp
1st name | Wataru |
Middle name | |
Last name | TAKAHASHI |
Dokkyo medical university hospital
Hematology and Oncology
321-0293
880 Kita-Kobayashi, Mibu-machi, Shimotsuga-gun Tochigi 321-0293, JAPAN
+81-282-86-1111
twataru@dokkyomed.ac.jp
Dokkyo medical university hospital, Hematology and Oncology
Dokkyo medical university hospital, Hematology and Oncology
Self funding
Dokkyo University Hospital, Rinnsyou Kennkyuu Kanri Center
880 Kita-Kobayashi, Mibu-machi, Shimotsuga-gun Tochigi 321-0293, JAPAN
0282-87-2275
r-kenkyu@dokkyomed.ac.jp
NO
自治医科大学付属病院 血液科(栃木県)
自治医科大学付属さいたま医療センター 血液科(埼玉県)
2016 | Year | 03 | Month | 21 | Day |
none
Unpublished
none
0
not existed
2020 | Year | 03 | Month | 27 | Day |
not existed
not existed
not existed
not existed
Completed
2016 | Year | 03 | Month | 21 | Day |
2015 | Year | 06 | Month | 04 | Day |
2016 | Year | 03 | Month | 21 | Day |
2018 | Year | 03 | Month | 20 | Day |
2016 | Year | 03 | Month | 21 | Day |
2020 | Year | 03 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024460
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