Status:
UNKNOWN
Individualized Induction Therapy for Non-elderly Acute Myeloid Leukemia Patients With Adverse Risk Features
Lead Sponsor:
The First Affiliated Hospital of Soochow University
Conditions:
Acute Myeloid Leukemia, Adult
Eligibility:
All Genders
18-59 years
Phase:
PHASE2
Brief Summary
Individualized induction therapy will be applied to the non-elderly acute myeloid leukemia (AML) patients with adverse genetic risk features guided by rapid screening with fluorescence in situ hybridi...
Detailed Description
The non-elderly AML patients who meet the adverse risk group defined as 2017 European LeukemiaNet (ELN) risk stratification, are more likely to be refractory to intensive induction and have low rates ...
Eligibility Criteria
Inclusion
- Male or female, 59 \> =Age (years) \>= 18;
- Newly diagnosed as AML patients according to World Health Organization (WHO) classification;
- AML patients meet the adverse risk group according to 2017 European Leukemia Net risk stratification;
- Patients have not received prior therapy for AML (except HU);
- Eastern Cooperative Oncology Group (ECOG) Performance status of 0,1, 2 ;
- Liver function: Total bilirubin ≦3 upper limit of normal (ULN); aspartate aminotransferase (AST) ≦3 ULN; alanine aminotransferase (ALT)≦3 ULN(except extramedullary infiltration of leukemia)
- Renal function：Ccr ≧30 ml/min;
- Patients who sign the informed consent must have the ability to understand and be willing to participate in the study and sign the informed consent.
Exclusion
- Acute promyeloid leukemia；
- AML with central nervous system (CNS) infiltration；
- Patients have received prior hypomethylating agents (HMA) therapy for myelodysplastic syndrome (MDS) and progressed to AML；
- HIV infection;
- Patients with severe heart failure (grade 3-4) ;
- Evidence of other clinically significant uncontrolled condition(s) including, but not limited to: a) Uncontrolled and/or active systemic infection (viral, bacterial or fungal); b) Chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment. c)An active second cancer that requires treatment within 6 months of study entry
- Patients deemed unsuitable for enrolment by the investigator;
- Patients willing to receive intensive induction chemotherapy
- Female who are pregnant, breast feeding or childbearing potential without a negative urine pregnancy test at screen；
- Patients reject to participate in the study.
Key Trial Info
Start Date :
February 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04752527
Start Date
February 20 2021
End Date
December 1 2022
Last Update
November 15 2021
Active Locations (1)
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1
The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology
Suzhou, Jiangsu, China, 215000