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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0005060

Enrollment

Registered

2020-05-27

Start date

2020-04-29

Completion date

Unknown

Last updated

2020-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Danazol starting dose will be 200 mg daily. Without the non-hematologic toxicities = CTCAE grade 2, the dose can be escalated to 400 mg in 2 divided doses after two weeks of treatment and to 60

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
hematologic improvement (HI): erythroid, platelet, and neutrophil response (IWG criteria)	—

Secondary

Measure	Time frame
overall survival (OS);leukemia-free survival (LFS);progression-free survival (PFS);Toxicity evaluation	—

Countries

Korea, Republic of

Contacts

Public ContactKyunghwa Lee

Asan Medical Center

Outcome results