UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037786
Receipt number R000042890
Scientific Title Real World Treatment Patterns and Clinical Outcomes in Unfit AML Patients Receiving First Line Systemic Treatment or Best Supportive Care (CURRENT)
Date of disclosure of the study information 2019/09/01
Last modified on 2021/02/03 09:13:19

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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 or person

Institute

AbbVie Inc.

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042890


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name