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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043659
Receipt No. 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 2021/04/03

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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 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

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) Patients with not achieved remission after induction therapies, or patients with progression after remission
5) Patients who are scheduled to receive quizartinib monotherapy
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) Pregnant or lactating patients, or patients who may be breastfeeding within 5 weeks of the last dose of quizartinib
7) 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
Institute Kanto Study Group for Cell Therapy
Institute
Department

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 Preinitiation
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
2027 Year 12 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
2021 Year 04 Month 03 Day


Link to view the page
URL(English) https://upload.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


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