Phase II study of NS-17 in elderly patients with acute myeloid leukemia.
Phase 2
Completed
- Conditions
- acute myeloid leukemia
- Registration Number
- JPRN-jRCT2080223699
- Lead Sponsor
- ippon Shinyaku Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
1. AML patients who are diagnosed of one of the following:
Newly diagnosed, histologically confirmed de novo AML or,
AML secondary to prior myelodysplastic disease or,
AML secondary to exposure to potentially leukemogenic therapies or agents with the primary malignancy.
2. Patients with bone marrow blasts>=30%.
3. Patients whose ECOG PS is 0, 1 or 2
Exclusion Criteria
1. Patients with previous cytotoxic treatment for AML.
2. Patients with previous treatment with hypomethylating agents or cytarabine.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>Overall survival
- Secondary Outcome Measures
Name Time Method efficacy<br>One-year overall survival rate