This is a randomized, open-label, multicenter study to compare the efficacy and safety of AZA with or without ATRA in newly diagnosed unfit AML or Intermediate,High or Very High Risk MDS
Newly diagnosed unfit AML and Intermediate,High or Very High Risk Myelodysplastic Syndromes (MDS) as Per IPSS-R Criteria are unable to tolerate the intensive chemo-therapy regimens due to their old age and poor physical condition, resulting in limited overall survival. Nowadays, AZA are recommended for unfit acute myeloid leukemia or myelodysplastic syndromes patients with remission rate of 30%\~34%. AZA with or without all-trans retinoic acid (ATRA) can cooperatively inhibit leukemia cell proliferation , induce apoptosis and differentiation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
180
Azacytidine 75mg/m2/d by IV on days 1-7 of every cycle 28 days
ATRA 20mg tid by po on days 1-21 of every cycle 28 days
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
RECRUITINGOverall Response Rate (ORR)
Number of participants (responders) achieving ORR after the 6 cycle treatments,Overall response rate (ORR) based on the International Working Group (IWG)-2006 criteria, which include complete remission (CR), partial remission (PR), and major hematologic improvement (HI).
Time frame: 6 months
Overall survival (OS)
time from randomization to death from any cause, or last known date to be alive.
Time frame: 24months
Progression-free survival (PFS)
Progression-free survival (PFS) will be measured from time of enrolling in the clinical trial to the date on which disease progresses or the date on which the patient dies, whichever comes first.
Time frame: 24 months
Percentage of Participants Achieving Transfusion Independence (TI) Who are Transfusion Dependent at Baseline
TI is when the participants who were transfusion dependent on RBC and/or Platelet at baseline achieve transfusion independence post baseline. TI is a period of at least 56 days with no transfusion after the date of the first dose of study drug to the last dose of study drug + 30 days, the initiation of post-treatment therapy, or death, whichever is earliest.
Time frame: 6 months
Incidence of systemic infections
Incidence of systemic infections
Time frame: 6 months
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