Unique ID issued by UMIN | UMIN000003433 |
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Receipt number | R000004157 |
Scientific Title | The phase II study for evaluating the effectiveness and safety of allogeneic hematopoietic stem cell transplantation for adult acute myeloid leukemia with FLT3/ITD mutation. -JALSG AML209-FLT3-SCT Study (AML209-FLT3-SCT)- |
Date of disclosure of the study information | 2010/04/02 |
Last modified on | 2020/04/09 10:45:02 |
The phase II study for evaluating the effectiveness and safety of allogeneic hematopoietic stem cell transplantation for adult acute myeloid leukemia with FLT3/ITD mutation. -JALSG AML209-FLT3-SCT Study (AML209-FLT3-SCT)-
Allogeneic hematopoietic stem cell transplantation for adult acute myeloid leukemia with FLT3/ITD mutation.
The phase II study for evaluating the effectiveness and safety of allogeneic hematopoietic stem cell transplantation for adult acute myeloid leukemia with FLT3/ITD mutation. -JALSG AML209-FLT3-SCT Study (AML209-FLT3-SCT)-
Allogeneic hematopoietic stem cell transplantation for adult acute myeloid leukemia with FLT3/ITD mutation.
Japan |
Acute myeloid leukemia
Hematology and clinical oncology |
Malignancy
NO
The purpose of this study is evaluating the effectiveness and safety of allogeneic hematopoietic stem cell transplantation at the 1st complete remission in adult acute myeloid leukemia with FLT3/ITD mutation.
Safety,Efficacy
Confirmatory
Pragmatic
Phase II
Disease-free survival at the 3 year.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine | Other |
After the consolidation therapies (1 to 4 courses), allogeneic hematopoietic stem cell transplantation is performed.
16 | years-old | <= |
50 | years-old | > |
Male and Female
(1) JALSG AML209-GS study registered patient.
(2) The patients without RUNX1-RUNX1T1, CBFB-MYH11 and PML-RARA transcripts.
(3) The patients with FLT3/ITD mutation.
(4) The patients who achieved CR within 2 courses of the induction therapy
(5) The patients who are not received the post-remission therapy.
(6) The patients with Performance status grade (ECOG) 0,1 or 2.
(7) The patients with the chemotherapy tolerable liver, kidney, lung and cardiac functions.
(1) Secondary AML
(2) The patients with the past history of hematopoietic disorder.
(3) The patients who received the induction therapy consisted of Gemtuzumab ozogamicin (Mylotarg).
(4) The patients who have been identified the cancer after the registration to the JALSG AML209-GS study.
(5) The patients who have developed myocardial infarction or angina after the registration to the JALSG AML209-GS study.
(6) The patients with cardiac dysfunction.
(7) The patients with active gastric ulcer.
(8) The patients with the uncontrollable ileus.
(9) The patients with the diabetes mellitus.
(10) The patients with active infection.
(11) The patients in whom the HBV-reactivation have been observed.
(12) Psycological patients.
60
1st name | Hitoshi |
Middle name | |
Last name | Kiyoi |
Nagoya University Hospital
Department of Hematology
466-8560
65 Tsurumai-cho, Showa-ku, Nagoya, Japan
052-744-2136
kiyoi@med.nagoya-u.ac.jp
1st name | Hitoshi |
Middle name | |
Last name | Kiyoi |
Nagoya University Hospital
Department of Hematology
466-8560
65 Tsurumai-cho, Showa-ku, Nagoya, Japan
052-744-2136
http://www.jalsg.jp/
kiyoi@med.nagoya-u.ac.jp
Japan adult leukemia study group
NPO JALSG
Other
Nagoya University Ethical commttee
65 Tsurumai-cho, Showa-ku, Nagoya, Japan
052-744-2804
ethics@med.nagoya-u.ac.jp
NO
2010 | Year | 04 | Month | 02 | Day |
Unpublished
No longer recruiting
2010 | Year | 01 | Month | 12 | Day |
2010 | Year | 02 | Month | 01 | Day |
2010 | Year | 02 | Month | 01 | Day |
2018 | Year | 12 | Month | 31 | Day |
2010 | Year | 04 | Month | 02 | Day |
2020 | Year | 04 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004157
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