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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000022185
Receipt No. R000025558
Scientific Title Analysis on response to darbepoetin alfa in patients with low risk myelodysplastic syndromes
Date of disclosure of the study information 2016/05/09
Last modified on 2020/05/07

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Basic information
Public title Analysis on response to darbepoetin alfa in patients with low risk myelodysplastic syndromes
Acronym Myelodysplastic syndrome 01 study in West Japan Hematology Study Group (W-JHS MDS01 study)
Scientific Title Analysis on response to darbepoetin alfa in patients with low risk myelodysplastic syndromes
Scientific Title:Acronym Myelodysplastic syndrome 01 study in West Japan Hematology Study Group (W-JHS MDS01 study)
Region
Japan

Condition
Condition Myelodysplastic syndromes
Classification by specialty
Hematology and clinical oncology Laboratory medicine
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To determine the existence of gene mutations that predict effectiveness of darbepoietin alfa in treating anemia of low risk (low or Int-1 in IPSS risk categories) MDS, mutation analysis of blood cells is performed, mainly focusing on highly frequent mutations including SF3B1, TET2, SFRS2, ASXL1, DNMT3A, RUNX1, and U2AF1. It is expected that the identification of effect prediction factors brings knowledge about the molecular pathology of ineffective erythropoiesis of patients with myelodysplastic syndromes
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Correlation between highly frequent gene mutations and hematological improvement according to IWG criteria 2006 (HI-E) to darbepoetin alfa until 16 weeks after the initiaion of treatment
Key secondary outcomes 1. Minor response to darbepoetin alfa until 16 weeks after the initiation of treatment in blood transfusion dependent patients.
2. Major response to darbepoetin alfa until 16 weeks after the initiation of treatment in blood transfusion dependent patients.
3. Hematological improvement according to IWG criteria 2003 (HI-E) by darbepoetin alfa until 16 weeks after the initiation of treatment in blood transfusion independent patients.
4. Variety and frequency of gene mutations observed in all subjects.
5. Correlation between decreased cell lineages (erythrocytes, leukocytes, platelets) and types of gene mutations.
6. Analysis on mortality and progression to AML from 16 weeks to 1 year after the initiaion of treatment.
7. Correlation between highly frequent gene mutations and interval to achievement of the first hematological improvement according to IWG criteria 2006 (HI-E) after the initiaion of treatment.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 The peripheral blood of patients is collected before administration of darbepoetin alfa, and DNA is extracted. The presence of gene mutations is then analyzed, mainly on highly frequent gene mutations (e.g. SF3B1, TET2, SFRS2, ASXL1, DNMT3A, RUNX1, U2AF1) on the panel of 104 genes in a previous report (Ogawa S, et al. Leukemia 2014) using next-generation sequencing method.
Darbepoetin alfa at a dose of 240 microgram per body is administered every 7 days for 16 times in total.
Effect of darbepoetin alfa is observed up to 16 weeks and it is statistically analyzed whether the presence of specific gene mutation affects the effectiveness or not.

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 1) Patients with definite diagnosis of MDS in diagnostic criteria of refractory anemia (myelodysplastic syndrome) (MHLW, Research and study group on idiopathic hematopoietic disorder, revised in 2010 fiscal year).
2) Patients having anemia associated with MDS, and is aged 16 years or older.
3) Patients categorized in Low or Int-1 risk in IPSS risk categories.
4) Patients who can visit participating institutions in prescribed schedule.
5) Patients providing the written informed consent (in the case of minor subject, taking from both the subject and legal representative).
Key exclusion criteria 1) Patients at risk of thromboembolism with present or past medical history of myocardial infarction, pulmonary infarction and cerebral infarction or similar disorders.
2) Patients with uncontrollable hypertension.
3) Patients with medical history of drug hypersensitivity to darbepoetin alfa or other erythropoietin formulation.
4) Patients with severe (need for hospital care, or judgement by investigators) or uncontrollable complication.
5) Patients inappropriate for study participation due to complication of mental disease or psychiatric symptom.
6) Patients with cognitive disorder.
7) Patients judged by investigators to be inappropriate for study participation.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kinuko Mitani
Organization Dokkyo Medical University School of Medicine
Division name Department of Hematology and Oncology
Zip code
Address 880 Kita-Kobayashi, Mibu-machi, Shimotsuga-gun, Tochigi 321-0293, JAPAN
TEL 0282-86-1111
Email kinukom-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Motoshi Ichikawa
Organization Dokkyo Medical University School of Medicine
Division name Department of Hematology and Oncology
Zip code
Address 880 Kita-Kobayashi, Mibu-machi, Shimotsuga-gun, Tochigi 321-0293, JAPAN
TEL 0282-86-1111
Homepage URL
Email motoshi-tky@umin.ac.jp

Sponsor
Institute Cooperative study between the West Japan Hematology Study Group and Clinical Research Support Center Kyushu
Institute
Department

Funding Source
Organization Kyowa Hakko Kirin 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
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
2016 Year 05 Month 09 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 No longer recruiting
Date of protocol fixation
2016 Year 04 Month 12 Day
Date of IRB
2016 Year 04 Month 12 Day
Anticipated trial start date
2016 Year 05 Month 09 Day
Last follow-up date
2020 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 05 Month 02 Day
Last modified on
2020 Year 05 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025558

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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