W-JHS MDS01

Phase 2

• Conditions: myelodysplastic syndrome

• Registration Number: JPRN-jRCTs071180016
• Lead Sponsor: Mitani Kinuko

Brief Summary

High-frequency (10% or more) gene mutations were found in SF3B1 (24 cases, 30.4%), TET2 (20 cases, 25.3%), SRSF2 (10 cases, 12.7%), ASXL1 (9 cases, 11.4%), and DNMT3A (8 cases, 10.1%). Overall response rate was 70.9%. Univariate logistic regression analysis did not show any significant association between these mutations and therapeutic efficacy of DA. The same results were obtained when the analysis was limited to red blood cell transfusion-dependent patients (n=15). To adjust against baseline erythropoiet

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-13
• Study Completion: 2020-08-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 85

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified