Danazol as first-line treatment for lower-risk myelodysplastic syndrome /chronic myelomonocytic leukemia with cytopenia and idiopathic cytopenia of undetermined significance

Not Applicable

Recruiting

Conditions: Diseases of the blood and blood -forming organs and certain disorders involving the immune mechanism

Registration Number: KCT0005060

Lead Sponsor: Asan Medical Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 53

Inclusion Criteria

•myelodysplastic syndrome or chronic myelomonocytic leukemia (CMML) defined by 2016 WHO classification with revised international prognostic scoring system = 3.5 from diagnosis to study enrollment
or
•Idiopathic cytopenia of undetermined significance
•Exclusion of underlying disease/condition that could explain cytopenia including myelodysplastic syndrome
and Presence of clinically significant cytopenia = 8 weeks
- Hemoglobin (Hb) < 10.0 g/dL
- Platelet < 100,000 /µL
- Absolute neutrophil count (ANC) < 800 / µL
•Bone marrow examination within 6 months before study enrollment
•18 years or older
•Adequate performance status (ECOG performance status of 2 or less)
•Adequate hepatic function (AST, ALT, and bilirubin < 2.0 × upper normal limit))

Exclusion Criteria

•Patients who have received hypomethylating agents, erythropoiesis stimulating agents, immunosuppressive therapy, or hematopoietic cell transplantation for myelodysplastic syndrome
•Patients with hereditary bone marrow failure syndromes (Faconi anemia, Diamond-Blackfan anemia, etc.)
•Patients with active thrombosis or thromboembolic disease or history of clinically significant thromboembolic events
•Patients with decompensated liver disease (uncontrolled ascites, variceal hemorrhage, or hepatic encephalopathy)
•Uncontrolled and/or active infection
•Nursing women, pregnant women, women of childbearing potential who do not want adequate contraception
•Patients with other solid cancer on active anti-cancer treatment
•Inability to understand the investigational nature of the study or to give informed consent or without a legally authorized representative or surrogate that can provide informed consent