Unique ID issued by UMIN | UMIN000022185 |
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Receipt number | 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 | 2023/05/08 09:43:05 |
Analysis on response to darbepoetin alfa in patients with low risk myelodysplastic syndromes
Myelodysplastic syndrome 01 study in West Japan Hematology Study Group (W-JHS MDS01 study)
Analysis on response to darbepoetin alfa in patients with low risk myelodysplastic syndromes
Myelodysplastic syndrome 01 study in West Japan Hematology Study Group (W-JHS MDS01 study)
Japan |
Myelodysplastic syndromes
Hematology and clinical oncology | Laboratory medicine |
Others
YES
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
Efficacy
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
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.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
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.
16 | years-old | <= |
Not applicable |
Male and Female
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).
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.
100
1st name | Kinuko |
Middle name | |
Last name | Mitani |
Dokkyo Medical University School of Medicine
Department of Hematology and Oncology
321-0293
880 Kita-Kobayashi, Mibu-machi, Shimotsuga-gun, Tochigi 321-0293, JAPAN
0282-86-1111
kinukom-tky@umin.ac.jp
1st name | Motoshi |
Middle name | |
Last name | Ichikawa |
Dokkyo Medical University School of Medicine
Department of Hematology and Oncology
321-0293
880 Kita-Kobayashi, Mibu-machi, Shimotsuga-gun, Tochigi 321-0293, JAPAN
0282-86-1111
motoshi-tky@umin.ac.jp
Cooperative study between the West Japan Hematology Study Group and Clinical Research Support Center Kyushu
Kyowa Kirin co., Ltd
Profit organization
Clinical Research Network Fukuoka Certified Review Board
3-1-1, Maidashi, Hig ashi-ku, Fukuoka, Fukuoka
0 9 2 -6 4 3 -7 1 7 1
m a il@ c rnfukuo ka .jp
NO
2016 | Year | 05 | Month | 09 | Day |
Partially published
85
Completed
2016 | Year | 04 | Month | 12 | Day |
2016 | Year | 04 | Month | 12 | Day |
2016 | Year | 05 | Month | 09 | Day |
2020 | Year | 08 | Month | 31 | Day |
2016 | Year | 05 | Month | 02 | Day |
2023 | Year | 05 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025558
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