UMIN-CTR Clinical Trial

Basic information
Public title	Observational study about the prognostic implication of chromosomal and genetic alterations in adult acute myeloid leukemia. -JALSG AML209 Genetic Study (AML209-GS)-
Acronym	Observational study about the prognostic implication of chromosomal and genetic alterations in adult acute myeloid leukemia.
Scientific Title	Observational study about the prognostic implication of chromosomal and genetic alterations in adult acute myeloid leukemia. -JALSG AML209 Genetic Study (AML209-GS)-
Scientific Title:Acronym	Observational study about the prognostic implication of chromosomal and genetic alterations in adult acute myeloid leukemia.
Region	Japan

Condition
Condition	Adult acute myeloid leukemia
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	In this study, we will comprehensively analyze the chromosomal and genetic alterations, which have been suggested to be involved in the development, progression and prognosis of acute myeloid leukemia. Based on these analyses, we intend to clarify the genotype which can stratify AML for adapting the individual therapy.
Basic objectives2	Others
Basic objectives -Others	Association of chromoaomal and genetic alterations with the prognosis.
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Disease-free survival in each genotype.
Key secondary outcomes

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	65 years-old >
Gender	Male and Female
Key inclusion criteria	(1) Untreated AML patients except for APL. (2) The patients who will be received the chemotherapy for obtaining the cure of AML. (3) The patients with Performance status grade (ECOG) 0,1,2 or 3. (4) The patients with the chemotherapy tolerable liver, kidney, lung and cardiac functions. (5) The patients from whom the informed consent for the chemotherapy have been obtained.
Key exclusion criteria	1. The patients who had received chemotherapy, irradiation or hematopoietic stem cell transplantation against acute leukemias of ambiguous lineage, myeloproliferative neoplasms, myeloid and lymphoid neoplasms with eosinophilia and abnormalities of PDGFRA, PDGFRB or FGFR1. 2. The patients with natural killer cell lymphoblastic leukemia / lymphoma. 3. The patients with active cancer. 4. The patients who developed myocardial infarction within 1 year. 5. The patients with diabetes which is uncontrollable even with insulin. 6. The patients with active infection. 7. The patients with liver cirrhosis. 8. The patients who have the past history of renal dysfunction. 9. The patients with deep vein thrombosis requiring the treatment. 10. The patients with psychological disease. 11. The women who is or may be in pregnancy. 12. The HBV antigen or HIV antibody positive patients.
Target sample size	1500

Research contact person
Name of lead principal investigator	1st name Kiyoi Middle name Last name Hitoshi
Organization	Nagoya University Hospital
Division name	Department of Hematology
Zip code	466-8560
Address	65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL	052-744-2136
Email	kiyoi@med.nagoya-u.ac.jp

Public contact
Name of contact person	1st name Kiyoi Middle name Last name Hitoshi
Organization	Nagoya University Hospital
Division name	Department of Hematology
Zip code	466-8560
Address	65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL	052-744-2136
Homepage URL	http://www.jalsg.jp/
Email	kiyoi@med.nagoya-u.ac.jp

Sponsor
Institute	Japan adult leukemia study group
Institute
Department

Funding Source
Organization	NPO JALSG
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Ethical committe of Nagoya University
Address	65 Tsurumai-cho, Showa-ku, Nagoya, Japan
Tel	052-744-2804
Email	ethics@med.nagoya-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

Other administrative information
Date of disclosure of the study information	2010 Year 04 Month 01 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	1826
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	No longer recruiting
Date of protocol fixation	2010 Year 01 Month 12 Day
Date of IRB	2010 Year 01 Month 28 Day
Anticipated trial start date	2010 Year 02 Month 01 Day
Last follow-up date	2020 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

(Analyzing genotype) 1. Karyotype 2. FLT3 gene mutation 3. NPM1 gene mutation 4. CEBPA gene mutation 5. MLL-PTD mutation 6. KIT gene mutation 7. NRAS gene mutation 8. TP53 gene mutation 9. WT1 gene mutation 10. IDH1 gene mutation 11. Combination of above genotypes (Assessment issues) 1. Disease-free survival at 5 year in each genotype. 2. Overall survival at 5 year in each genotype. 3. Association of hematopoietic stem cell transplantation with DFS and OS in each genotype. 4. Complete remission rate in each genotype. 5. Proportion of each genotype in adult AML. 6. Association of each genotype with previously established prognostic factors. 7. Association of each genotype with the FAB classification and WHO classification. 8. Association of each genotype with the clinical characteristics at the diagnosis.

Management information
Registered date	2010 Year 04 Month 01 Day
Last modified on	2020 Year 04 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000004156