UMIN-CTR Clinical Trial

Basic information
Public title	Clinical observation study of 5-year survivals in patients with newly diagnosed acute myelogenous leukemia (AML), myelodysplastic syndromes (MDS), and chronic myelomonocytic leukemia (CMML) in Japan Adult Leukemia Study Group
Acronym	JALSG AML/MDS/CMML Clinical Observational Study (JALSG-CS)-11
Scientific Title	Clinical observation study of 5-year survivals in patients with newly diagnosed acute myelogenous leukemia (AML), myelodysplastic syndromes (MDS), and chronic myelomonocytic leukemia (CMML) in Japan Adult Leukemia Study Group
Scientific Title:Acronym	JALSG AML/MDS/CMML Clinical Observational Study (JALSG-CS)-11
Region	Japan

Condition
Condition	Acute myelogenous leukemia (AML), myelodysplastic syndromes (MDS), and chronic myelomonocytic leukemia (CMML)
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	5-year survivals of acute myelogenous leukemia (AML), myelodysplastic syndromes (MDS), and chronic myelomonocytic leukemia (CMML), and usage conditions of new agents, lenalidomide and DNMT inhibitors.
Basic objectives2	Others
Basic objectives -Others	(1) AML patient 5-year survivals (2) MDS patient 5-year survivals (3) CMML patient 5-year survivals (4) Usage conditions and efficacy of new agents (lenalidomide and DNMT inhibitors) in MDS patients (5) Numbers of patients with AML, MDS, CMML by age group, sex and type of diseases (6) Feasibility of classification according to known prognostic factors in AML, MDS, CMML. (7) Comparison of survivals between patients enrolled in AML209 study and not enrolled. (8) Usage conditions and efficacy of new agents (DNMT inhibitors) in CMML patients (9) Efficacy of DNMT inhibitors in lower risk MDS (IPSS low/Int-1 risk) (10) Frequency of Erythropoiesis-stimulating agent (ESA) use.
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	(1) AML patient 5-year survivals (2) MDS patient 5-year survivals (3) CMML patient 5-year survivals (4) Usage conditions and efficacy of new agents (lenalidomide and DNMT inhibitors) in MDS patients (5)) Numbers of patients with AML, MDS, CMML by age group, sex and type of diseases (6) Feasibility of classification according to known prognostic factors in AML, MDS, CMML. (7) Comparison of survivals between patients enrolled in AML209 study and not enrolled. (8) Usage conditions and efficacy of new agents (DNMT inhibitors) in CMML patients
Key secondary outcomes	(1) Efficacy of DNMT inhibitors in lower risk MDS (IPSS low/Int-1 risk) (2) Frequency of Erythropoiesis-stimulating agent (ESA) use.

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
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Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Newly diagnosed AML, MDS, and CMML
Key exclusion criteria	Past history of chemotherapy or stem cell transplantation in the treatment of AML, MDS, or CMML
Target sample size	6100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kensuke Usuki
Organization	JALSG-CS-11 research secretariat
Division name	Division of Hematology, NTT Medical Center Tokyo
Zip code
Address	Higashi-Gotanda 5-9-22, Shinagawa-ku, Tokyo, Japan Zip code 141-8625
TEL	03-3448-6584
Email	kensuke.usuki@gmail.com

Public contact
Name of contact person	1st name Middle name Last name Kensuke Usuki
Organization	NTT Medical Center Tokyo
Division name	Division of Hematology
Zip code
Address	Higashi-Gotanda 5-9-22, Shinagawa-ku, Tokyo, Japan Zip code 141-8625
TEL	03-3448-6584
Homepage URL	http://www.jalsg.jp
Email	kensuke.usuki@gmail.com

Sponsor
Institute	Japan Adult Leukemia Study Group
Institute
Department

Funding Source
Organization	Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2012 Year 07 Month 20 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	Completed
Date of protocol fixation	2011 Year 06 Month 06 Day
Date of IRB	2011 Year 07 Month 12 Day
Anticipated trial start date	2011 Year 08 Month 01 Day
Last follow-up date	2021 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

(1) AML patient 5-year survivals (2) MDS patient 5-year survivals (3) CMML patient 5-year survivals (4) Usage conditions and efficacy of new agents (lenalidomide and DNMT inhibitors) in MDS patients (5) Numbers of patients with AML, MDS, CMML by age group, sex and type of diseases (6) Feasibility of classification according to known prognostic factors in AML, MDS, CMML. (7) Comparison of survivals between patients enrolled in AML209 study and not enrolled. (8) Usage conditions and efficacy of new agents (DNMT inhibitors) in CMML patients

Management information
Registered date	2012 Year 07 Month 06 Day
Last modified on	2022 Year 11 Month 18 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009841