This is a combination study to evaluate sapacitabine administered in alternating cycles with decitabine in previously untreated Acute Myeloid Leukemia (AML) or concomitantly with venetoclax in previously treated AML or MDS
This is an open-label, single arm, study of sapacitabine administered in alternating cycles with decitabine in elderly patients with previously untreated AML (Part 1) or concomitantly with venetoclax in adult patients with relapsed or refractory AML or MDS (Part 2). Treatment will be administered on an outpatient basis. One treatment cycle is 4 weeks.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
65
decitabine will be administered in alternating cycles with sapacitabine
sapacitabine will be administered concomitantly with venetoclax
Rush University Medical Center
Chicago, Illinois, United States
COMPLETEDRoswell Park Cancer Institute
Buffalo, New York, United States
COMPLETEDMD Anderson Cancer Center
Houston, Texas, United States
RECRUITINGNumber of patients who achieve a clinical benefit response including CR, CRp, PR and major HI
Time frame: 2 years
response duration
Time frame: 2 years
transfusion requirements
Time frame: 2 years
hospitalized days
Time frame: 2 years
overall survival
Time frame: 2 years
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