UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060610 |
|---|---|
| Receipt number | R000069327 |
| Scientific Title | An Interview Study on the Burden and Impact on Daily Life Among Patients with Acute Myeloid Leukemia (AML) |
| Date of disclosure of the study information | 2026/02/06 |
| Last modified on | 2026/02/06 22:50:33 |
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Basic information
Public title
An Interview Study on the Burden and Impact on Daily Life Among Patients with Acute Myeloid Leukemia (AML)
Acronym
An Interview Study on the Burden and Impact on Daily Life Among Patients with Acute Myeloid Leukemia (AML)
Scientific Title
An Interview Study on the Burden and Impact on Daily Life Among Patients with Acute Myeloid Leukemia (AML)
Scientific Title:Acronym
An Interview Study on the Burden and Impact on Daily Life Among Patients with Acute Myeloid Leukemia (AML)
Region
| Japan |
Condition
Condition
Acute Myeloid Leukemia
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the burden experienced by patients with relapsed/refractory acute myeloid leukemia (AML) in their daily lives, and the impact of AML on their daily activities.
Basic objectives2
Others
Basic objectives -Others
To identify and understand the symptoms and challenges caused by acute myeloid leukemia (AML)
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
AML-related symptoms and daily-life difficulties, and their perceived impact on everyday living and activities.
Key secondary outcomes
Experiences related to AML (diagnosis, treatment, etc.) from the time of notification of relapsed/refractory AML up to the present.
Coping strategies for burdens and difficulties in daily life, and the kinds of medical support received.
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
1) Patients with relapsed or refractory AML (including progression from other hematological malignancies such as myelodysplastic syndrome or secondary AML) who are 18 years of age or older at the time of informed consent, and who achieved Complete Remission (CR) or CR with incomplete hematologic recovery (CRi) following pharmacotherapy for the first episode of relapsed/refractory AML.
2) Patients who achieved remission within one year prior to consent following treatment for relapsed or refractory AML.
3) Patients with an Eastern Cooperative Oncology Group Performance Status (ECOG-PS) of 0 or 1 at the time of consent.
4) Patients capable of participating in a web-based interview of approximately one hour.
Key exclusion criteria
1) Patients who relapsed within one year after achieving CR or CRi following initial standard therapy for AML.
2) Patients who relapsed within one year after undergoing hematopoietic stem cell transplantation (HSCT) as part of initial AML treatment.
3) Patients receiving immunosuppressive therapy following HSCT at the time of consent, those with clinically active graft-versus-host disease (GVHD), or those requiring treatment for GVHD (excluding topical steroid use for skin GVHD).
4) Patients who underwent HSCT after pharmacotherapy for relapsed/refractory AML.
5) Patients with comorbid conditions at the time of consent, including congestive heart failure, uncontrolled infections, human immunodeficiency virus (HIV), active hepatitis B or C, or other active liver diseases.
6) Patients who underwent major surgery or received radiation therapy within 28 days prior to the web interview.
7) Patients with a history of participation in clinical trials targeting relapsed/refractory AML.
8) Patients with a prior diagnosis of dementia.
9) Patients currently undergoing treatment for psychiatric disorders.
10) Patients with active concurrent malignancy (excluding those curatively treated with local therapy).
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Ikezoe |
Organization
Fukushima Medical University
Division name
Department of Hematology
Zip code
960-1295
Address
1Hikariga-oka, Fukushima City, Fukushima, 960-1295, JAPAN
TEL
024-547-1193
ikezoet@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Sae |
| Middle name | |
| Last name | Hiroha |
Organization
Mebix, Inc
Division name
Clinical Operations
Zip code
105-0001
Address
Toranomon 33 Mori Building 3-8-21 Toranomon, Minato-ku, Tokyo, 105-0001, JAPAN
TEL
03-4362-4500
Homepage URL
AMLptint2025@mebix.co.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Sumitomo Pharma 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
Fukushima Medical University Ethics Committee
Address
1Hikariga-oka, Fukushima City, Fukushima, 960-1295, JAPAN
Tel
024-547-1825
rs@fmu.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
| 2026 | Year | 02 | Month | 06 | 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
| 2025 | Year | 10 | Month | 22 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 17 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 10 | Day |
Last follow-up date
| 2026 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Semi-structured interview study, Cross-sectional study
Management information
Registered date
| 2026 | Year | 02 | Month | 06 | Day |
Last modified on
| 2026 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069327
