Unique ID issued by UMIN | UMIN000043659 |
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Receipt number | R000049859 |
Scientific Title | Quizartinib cohort study bridging to hematopoietic stem cell transplantation in patients with FLT3-ITD positive acute myeloid leukemia; QUICHE study. |
Date of disclosure of the study information | 2021/04/01 |
Last modified on | 2023/11/24 09:56:30 |
Multicenter prospective observational study of hematopoietic stem cell transplantation after quizartinib in patients with FLT3-ITD positive relapsed or refractory acute myeloid leukemia .
Quizartinib cohort study bridging to hematopoietic stem cell transplantation in patients with FLT3-ITD positive acute myeloid leukemia; QUICHE study.
Quizartinib cohort study bridging to hematopoietic stem cell transplantation in patients with FLT3-ITD positive acute myeloid leukemia; QUICHE study.
KSGCT2101(Quiche)
Japan |
Acute myeloid leukemia
Hematology and clinical oncology |
Malignancy
YES
Purpose of the study is to search the actual situation in patients with FLT3-ITD positive untreated, relapsed and/or refractory acute myeloid leukemia treated with quizartinib.
Others
Minimal residual disease: MRD
Clinical data of hematopoietic stem cell transplantation after quizartinib
Reasons for allogeneic transplant
Stem cell source
Event-free survival: EFS
Conditioning regimen
Graft-versus-host disease :GVHD
Cumulative incidences of relapse:CIR
Cumulative incidences of non relapse mortality:NRM
Clinical data for outcomes of quizartinib
bridge to transplantation rate
CRc[Composite complete remission]; CR[Complete remission]+CRi[Complete remission with incomplete hematologic recovery]
Overall response rate: ORR
Time to CRc
Overall survival: OS
Blood transfusion dependency rate
Re-administration of quizartinib
Adverse events of quizartinib
Observational
20 | years-old | <= |
70 | years-old | >= |
Male and Female
1) Patients with written consent to participate in this study
2) Patients aged 20 to 70 years
3) Patients diagnosed with AML based on WHO classification (2017)
4) Untreated patients, patients with not achieved remission after induction therapies, or patients with progression after remission
5) Patients scheduled to receive quizartinib at the stage of disease ("primary" or "relapsed or refractory") at the time of enrollment.
6) Patients with ECOG PS 0 to 2
7) Patients who are scheduled to allogeneic stem cell transplantation
8) Patients who agree to contraception for several period of time (3 months for male and 6 months for female) during this study and after the final dose of quizartinib
1) Patients treated with quizartinib
2) Patients with multiple malignancies other than AML
3) Patients diagnosed with acute promyelocytic leukemia
4) Patients with a QTcF (Fridericia-corrected QT interval) greater than 450 msec as a result of the latest electrocardiogram measured within 14 days prior to enrollment
5) Patients known to have HIV or HBV
6) Patients who have already achieved remission with treatment other than quizartinib at the stage of disease ("primary" or "relapsed or refractory") at the time of enrollment and are scheduled to receive allo-HSCT.
7) Pregnant or lactating patients, or patients who may be breastfeeding within 5 weeks of the last dose of quizartinib
8) Patients who are otherwise classified as unfit by the attending physicians for this research.
40
1st name | Hiroto |
Middle name | |
Last name | Ishii |
The Jikei University School of Medicine
Division of Clinical Oncology and Hematology
105-8471
3-19-18 Nishishinbashi, Minato-ku, Tokyo
03-3433-1111
ksgctdc@ksgct.net
1st name | Hiroto |
Middle name | |
Last name | Ishii |
The Jikei University School of Medicine
Division of Clinical Oncology and Hematology
105-8471
3-19-18 Nishishinbashi, Minato-ku, Tokyo
03-3433-1111
ksgctdc@ksgct.net
Kanto Study Group for Cell Therapy
Daiichi Sankyo Co., Ltd.
Profit organization
The Jikei University School of Medicine
3-25-18 Nishishinbashi, Minato-ku, Tokyo
03-3433-1111
rinri@jikei.ac.jp
NO
2021 | Year | 04 | Month | 01 | Day |
Unpublished
Open public recruiting
2021 | Year | 03 | Month | 08 | Day |
2021 | Year | 03 | Month | 08 | Day |
2021 | Year | 04 | Month | 01 | Day |
2028 | Year | 03 | Month | 31 | Day |
Study design:prospective observational study
Under the collection of cases at multi-institutional collaboration study
2021 | Year | 03 | Month | 18 | Day |
2023 | Year | 11 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049859
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