Phase
Condition
Myelodysplastic Syndromes (Mds)
White Cell Disorders
Treatment
Placebo
Lisaftoclax (APG-2575)
Azacitidine Injection
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Newly diagnosed higher-risk MDS.
ECOG score of ≤2.
Expected survival ≥ 3 months.
Adequate organ function.
Female subjects of potential childbearing potential have a negative urine or serumpregnancy test before dosing. Subjects of childbearing potential as well as theirpartners voluntarily use contraception deemed effective by the investigator duringthe treatment period and for at least six months after the last dose of study drug.
Able to understand and voluntarily sign a written informed consent form, which mustbe signed prior to the performance of any trial-specified study procedures.
Subjects are able to complete study procedures and follow-up examinations.
Exclusion
Exclusion Criteria:
Concomitant other malignancies or prior malignancies with disease-free intervals ofless than 1 year at the time of signing the informed consent.
Have undergone hematopoietic stem cell transplantation.
Uncontrolled active infection
Use of moderately potent inducers and moderately potent inhibitors of CYP3A4 within 14 days prior to the first dose of study drug.
MDS or other conditions that cannot be administered enterally.
Any condition that the subject is deemed to be inappropriate to participate in thisstudy after evaluation by the investigator.
Study Design
Study Description
Connect with a study center
Peking University People's Hospital
Beijing, Beijing 100033
ChinaSite Not Available
Peking University People's Hospital
Beijing 1816670, Beijing Municipality 2038349 100033
ChinaActive - Recruiting
MD Anderson Cancer Center
Houston, Texas 77054
United StatesSite Not Available
MD Anderson Cancer Center
Houston 4699066, Texas 4736286 77054
United StatesActive - Recruiting

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