UMIN-CTR Clinical Trial

Basic information
Public title	Real World Treatment Patterns and Clinical Outcomes in Unfit AML Patients Receiving First Line Systemic Treatment or Best Supportive Care (CURRENT)
Acronym	Real World Treatment Patterns and Clinical Outcomes in Unfit AML Patients Receiving First Line Systemic Treatment or Best Supportive Care
Scientific Title	Real World Treatment Patterns and Clinical Outcomes in Unfit AML Patients Receiving First Line Systemic Treatment or Best Supportive Care (CURRENT)
Scientific Title:Acronym	Real World Treatment Patterns and Clinical Outcomes in Unfit AML Patients Receiving First Line Systemic Treatment or Best Supportive Care
Region	Japan Asia(except Japan) North America South America Australia Europe

Condition
Condition	Acute myeloid leukemia
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the overall survival of AML patients unfit for intensive chemotherapy and who received systemic treatment including Low Intensity Chemotherapy (LIC), targeted therapy or Best Supportive Care (BSC) in the real world setting.
Basic objectives2	Others
Basic objectives -Others	To describe the clinical outcomes, patient demographics, clinicopathologic characteristics, cytogenetic and molecular profiles, treatment patterns, healthcare resource utilization of this cohort of AML patients.
Trial characteristics_1	Others
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Overall Survival(OS) OS will be defined as the time (in months) from the date of confirmed diagnosis of AML (i.e., the index date) to death (any cause) as documented in the medical chart. Patients who did not die within the study observation period will be censored on the study end date or the last contact date available in the dataset, whichever occurred first.
Key secondary outcomes	Progression Free Survival(PFS) PFS is measured from the date of confirmed diagnosis of AML to the date of physician-assessed disease progression or death due to any cause. Time to Treatment failure(TTF) TTF is measured as the time from start of systemic therapy including LIC, targeted therapy or BSC until discontinuation of the treatment for any reason including disease progression, death, toxicity, or patient or physician choice. Healthcare Resource Utilization(HRU) HRU will be descriptively assessed as the median number of times the patients receive transfusions (differentiating RBC and platelet transfusions), median number of days hospitalized or admitted to ICU, the median number of Outpatient consultations, supportive care received (e.g., growth factors), antibiotics use for infections and other medications (e.g., CYP3A inhibitors) following initiation of low intensity chemotherapy, targeted therapy or BSC until discontinuation of this initial treatment for any reason. MRD Testing rates including methodology as available Detectable residual leukemic cells are referred to as Measureable Residual Disease (MRD; formerly Minimal Residual Disease). MRD can be measured using multiparameter flow cytometry, or real-time quantitative polymerase chain reaction (RT-qPCR) or Next Generation Sequencing. MRD testing rates will be collected based on current clinical practice, and methodology of testing will be collected if applicable. It is possiblethat patients have multiple MRD response assessments in their charts during this period. All documented responses (along with the associated progress note date) will be captured. For purpose of analysis, only best response will be used. Response Rate per Physician Assessment Rates of Complete Remission(CR), time to achieve CR, duration of CR, CR with incomplete hematologic recovery (CRi), Morphologic Leukemia Free State, Partial Remission, and Treatment Failure will be captured, per physician assessment.

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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Adult(>= 18 years old) male or female diagnosed with primary or secondary AML Deemed ineligible for intensive induction chemotherapy because of age, performance status, comorbidities as defined by treating physician Have received systemic therapy including low intensity chemotherapy, targeted therapy or BSC for AML in the 1L setting During the treatment period, patients must have >= 2 visits in addition to the initial event visit(referred to as the index date, defined as start of low intensity chemotherapy or BSC) -Visits are defined as physical encounters with the practice, detected by vital sign records; -The second and third visits must be observed after the index date to demonstrate continuity of care; -There is no required time span between the additional visits and the index date
Key exclusion criteria	AML diagnosis not confirmed Acute Promyelocytic Leukemia Received First line AML treatment within a clinical study
Target sample size	1600

Research contact person
Name of lead principal investigator	1st name Alexander Middle name Last name Delgado
Organization	AbbVie Inc.
Division name	Medical
Zip code	138588
Address	9 North Buona Vista Drive, #19-01 The Metropolis Tower One Singapore
TEL	65-67158279
Email	alexander.delgado@abbvie.com

Public contact
Name of contact person	1st name Harumi Middle name Last name Mukai
Organization	AbbVie GK
Division name	Medical
Zip code	108-0023
Address	3-1-21, Shibaura, Minato-ku Tokyo 108-0023, Japan
TEL	03-4577-1111
Homepage URL
Email	harumi.mukai@Abbvie.com

Sponsor
Institute	AbbVie Inc.
Institute
Department

Funding Source
Organization	AbbVie Inc.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	United States of America

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kyushu University Hospital Ethics Committee
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, JAPAN
Tel	092-642-5774
Email	bynintei@jimu.kyushu-u.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	九州大学病院（福岡県） 浜の町病院（福岡県） 岡山市立市民病院（岡山県） 大阪赤十字病院（大阪府） 近畿大学病院（大阪府） 関西医科大学付属病院（大阪府） 京都第二赤十字病院（京都府） 名古屋大学医学部附属病院（愛知県） 順天堂大学医学部附属順天堂医院（東京都） 国立病院機構災害医療センター（東京都） 埼玉医科大学総合医療センター（埼玉県） 国立病院機構水戸医療センター（茨城県） 国立病院機構仙台医療センター（宮城県） 愛育病院（北海道） なお、上記は日本からの参加施設である（倫理委員会通過施設）。本試験は国際共同研究であり、約30カ国の国や地域の施設が参加する。

Other administrative information
Date of disclosure of the study information	2019 Year 09 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	https://ash.confex.com/ash/2020/webprogram/Paper140066.html
Number of participants that the trial has enrolled	1762
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	Completed
Date of protocol fixation	2019 Year 06 Month 07 Day
Date of IRB	2019 Year 08 Month 23 Day
Anticipated trial start date	2019 Year 09 Month 30 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry	2020 Year 03 Month 31 Day
Date trial data considered complete	2020 Year 03 Month 31 Day
Date analysis concluded

Other
Other related information	This study is a non-interventional, retrospective chart review of diagnosed AML patients.

Management information
Registered date	2019 Year 08 Month 24 Day
Last modified on	2021 Year 02 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042890