Last updated: August 18, 2022
Sponsor: The First Affiliated Hospital of Soochow University
Overall Status: Active - Recruiting
Phase
2/3
Condition
N/ATreatment
N/AClinical Study ID
NCT05404906
SZ-AML124
Ages 18-64 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Diagnosis of favorable-risk acute myeloid leukemia (AML) according to revised 2017European LeukemiaNet genetic risk stratification and are not immediate candidates forallogeneic stem cell transplant.
- Aged 18-64 years.
- Patients who have received remission induction therapy and 3-4 HiDAC or medium-dosecytarabine-based consolidation and are in their first remission.
- ECOG performance status of < or = 3.
- Adequate organ function as follows:
- Serum total bilirubin < or = to 3 X the Upper Limit of Normal (ULN)
- Aspartate Transaminase and alanine transaminase < or = to 3 x ULN
- Ccr(Creatinine Clearance Rate) > or =60 ml/min
- Left ventricular ejection fraction > or =50% determined by ultrasound.
- For females of childbearing age, they should have a negative serum or urine pregnancytest within 10 to 14 days of enrolling.
- For males of childbearing age, they should take effective contraceptive methodsthroughout the treatment period and up to 30 days after discontinuing treatment.
- Ability to understand and sign informed consent.
Exclusion
Exclusion Criteria:
- Acute promyeloid leukemia.
- Patients with active central nervous system (CNS) leukemia.
- Previously diagnosed with myelodysplastic syndrome (MDS) or myeloproliferativeneoplasm(MPN) and progressed to AML.
- Patients with other progressive malignancies.
- Evidence of other clinically significant uncontrolled condition(s) including, but notlimited to uncontrolled and/or active systemic infection (viral, bacterial or fungal).
- Patients who have participated in other trials within 30 days before signing theinformed consent.
- Females who are pregnant or lactating or intending to become pregnant during thestudy.
Study Design
Total Participants: 124
Study Start date:
June 25, 2022
Estimated Completion Date:
June 30, 2030
Connect with a study center
First Affiliated Hospital of Soochow University
Suzhou, Jiangsu 215000
ChinaActive - Recruiting
The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology
Suzhou, Jiangsu 215000
ChinaActive - Recruiting
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