Myelodysplastic syndromes
Conditions
Interventions
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 mutation
Sponsors
Cooperative study between the West Japan Hematology Study Group and Clinical Research Support Center Kyushu
Eligibility
Sex/Gender
All
Inclusion criteria
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).
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactMotoshi Ichikawa
Dokkyo Medical University School of Medicine Department of Hematology and Oncology
Outcome results
None listed