UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043659
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

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Basic information

Public title

Multicenter prospective observational study of hematopoietic stem cell transplantation after quizartinib in patients with FLT3-ITD positive relapsed or refractory acute myeloid leukemia .

Acronym

Quizartinib cohort study bridging to hematopoietic stem cell transplantation in patients with FLT3-ITD positive acute myeloid leukemia; QUICHE study.

Scientific Title

Quizartinib cohort study bridging to hematopoietic stem cell transplantation in patients with FLT3-ITD positive acute myeloid leukemia; QUICHE study.

Scientific Title:Acronym

KSGCT2101(Quiche)

Region

Japan


Condition

Condition

Acute myeloid leukemia

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

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.

Basic objectives2

Others

Basic objectives -Others

Minimal residual disease: MRD

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

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

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

70 years-old >=

Gender

Male and Female

Key inclusion criteria

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

Key exclusion criteria

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.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Hiroto
Middle name
Last name Ishii

Organization

The Jikei University School of Medicine

Division name

Division of Clinical Oncology and Hematology

Zip code

105-8471

Address

3-19-18 Nishishinbashi, Minato-ku, Tokyo

TEL

03-3433-1111

Email

ksgctdc@ksgct.net


Public contact

Name of contact person

1st name Hiroto
Middle name
Last name Ishii

Organization

The Jikei University School of Medicine

Division name

Division of Clinical Oncology and Hematology

Zip code

105-8471

Address

3-19-18 Nishishinbashi, Minato-ku, Tokyo

TEL

03-3433-1111

Homepage URL


Email

ksgctdc@ksgct.net


Sponsor or person

Institute

Kanto Study Group for Cell Therapy

Institute

Department

Personal name



Funding Source

Organization

Daiichi Sankyo Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

The Jikei University School of Medicine

Address

3-25-18 Nishishinbashi, Minato-ku, Tokyo

Tel

03-3433-1111

Email

rinri@jikei.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2021 Year 04 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Open public recruiting

Date of protocol fixation

2021 Year 03 Month 08 Day

Date of IRB

2021 Year 03 Month 08 Day

Anticipated trial start date

2021 Year 04 Month 01 Day

Last follow-up date

2028 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Study design:prospective observational study
Under the collection of cases at multi-institutional collaboration study


Management information

Registered date

2021 Year 03 Month 18 Day

Last modified on

2023 Year 11 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049859


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name