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 |
Real World Treatment Patterns and Clinical Outcomes in Unfit AML Patients Receiving First Line Systemic Treatment or Best Supportive Care (CURRENT)
Real World Treatment Patterns and Clinical Outcomes in Unfit AML Patients Receiving First Line Systemic Treatment or Best Supportive Care
Real World Treatment Patterns and Clinical Outcomes in Unfit AML Patients Receiving First Line Systemic Treatment or Best Supportive Care (CURRENT)
Real World Treatment Patterns and Clinical Outcomes in Unfit AML Patients Receiving First Line Systemic Treatment or Best Supportive Care
Japan | Asia(except Japan) | North America |
South America | Australia | Europe |
Acute myeloid leukemia
Hematology and clinical oncology |
Malignancy
NO
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.
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.
Others
Pragmatic
Not applicable
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.
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.
Observational
18 | years-old | <= |
Not applicable |
Male and Female
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
AML diagnosis not confirmed
Acute Promyelocytic Leukemia
Received First line AML treatment within a clinical study
1600
1st name | Alexander |
Middle name | |
Last name | Delgado |
AbbVie Inc.
Medical
138588
9 North Buona Vista Drive, #19-01 The Metropolis Tower One Singapore
65-67158279
alexander.delgado@abbvie.com
1st name | Harumi |
Middle name | |
Last name | Mukai |
AbbVie GK
Medical
108-0023
3-1-21, Shibaura, Minato-ku Tokyo 108-0023, Japan
03-4577-1111
harumi.mukai@Abbvie.com
AbbVie Inc.
AbbVie Inc.
Profit organization
United States of America
Kyushu University Hospital Ethics Committee
3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, JAPAN
092-642-5774
bynintei@jimu.kyushu-u.ac.jp
NO
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。
2019 | Year | 09 | Month | 01 | Day |
Published
https://ash.confex.com/ash/2020/webprogram/Paper140066.html
1762
Completed
2019 | Year | 06 | Month | 07 | Day |
2019 | Year | 08 | Month | 23 | Day |
2019 | Year | 09 | Month | 30 | Day |
2020 | Year | 03 | Month | 31 | Day |
2020 | Year | 03 | Month | 31 | Day |
2020 | Year | 03 | Month | 31 | Day |
This study is a non-interventional, retrospective chart review of diagnosed AML patients.
2019 | Year | 08 | Month | 24 | Day |
2021 | Year | 02 | Month | 03 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042890
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