Modified Low dose Cytarabine versus Hypomethylating agent in Elderly AML patients who are unfit for intensive chemotherapy: Randomized clinical study

Not Applicable

Recruiting

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

• Registration Number: KCT0001891
• Lead Sponsor: The Catholic University of Korea, Seoul St. Mary's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

•Patients with 65 years or older and unfit for intensive chemotherapy
(Satisfying at least 1 condition below)
- Poor-risk molecular cytogenetics group
- At least 2 conditions among followings (75 years old or older, ECOG (Eastern Cooperative Oncology Group) performance score 2-4, leukocyte counts at diagnosis > 50,000/microL)
- HCT-CI (Hematopoietic cell transplantation - comorbidity index) score with 3 or more
•Sufficient liver or renal function (= 2.5 x upper normal limit)

Exclusion Criteria

•Acute promyelocytic leukemia presenting t(15;17) or PML/RARa
•Central nervous system involvement
•Myeloid sarcoma without bone marrow involvement
•Uncontrolled prior infectious disease
•Uncontrolled bleeding
•Remnant previous malignancies in another organ
•Serious cardiovascular disease within 6 months from screening

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
2-year overall survival and disease free survival

Secondary Outcome Measures

Name	Time	Method
Treatment response including complete remission and incomplete remission, treatment complication and infectious complications and mortaility rate