UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008371 |
|---|---|
| Receipt number | R000009841 |
| 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 |
| Date of disclosure of the study information | 2012/07/20 |
| Last modified on | 2022/11/18 16:26:17 |
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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
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
| 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
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
kensuke.usuki@gmail.com
Sponsor or person
Institute
Japan Adult Leukemia Study Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009841
