Status:
ACTIVE_NOT_RECRUITING
Intensive Therapy Combined With Venetoclax for Adult Acute Myeloid Leukemia
Lead Sponsor:
Institute of Hematology & Blood Diseases Hospital, China
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief Summary
300 patients will be randomly distributed into the control group (n=150) and the experimental group(n=150). Patients will receive two cycles of induction chemotherapy. The control group receives stand...
Eligibility Criteria
Inclusion
- Patients with newly diagnosed AML (except for APL subtype) according to 2016 World Health Organization (WHO) classification and have not received chemotherapy before.
- Age ≥18 years and ≤65 years.
- Patient considered eligible for intensive chemotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 at randomization.
- Adequate renal function as evidenced by serum creatinine ≤ 2.0 × upper limit of norm (ULN) or creatinine clearance \>40 mL/min based on the Cockcroft-Gault glomerular filtration rate (GFR).
- Adequate hepatic function as evidenced by:(1) Serum total bilirubin ≤ 1.5 × ULN unless considered due to Gilbert's disease, or leukemic involvement following approval by the Coordinating Investigator or Trial Coordinator;(2) Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 2.5 × ULN, unless considered due to leukemic involvement following approval by the Coordinating Investigator or Trial Coordinator;(3)Myocardial enzyme\<2.0×upper limit normal;(4)Left ventricular ejection fraction are within the normal range by measure of echocardiogram (ECHO)
- No prior chemotherapy for AML except hydroxyurea for up to 14 days during the diagnostic screening phase for the control of peripheral leukemic blasts in patients with leukocytosis (e.g., white blood cell \[WBC\] counts \> 25x109/L).
- Able to understand and willing to sign an informed consent form (ICF).
Exclusion
- AML with BCR-ABL1; or myeloid blast crisis of CML.
- Subjects who have received a prior treatment for AML with chemotherapy , hypomethylating agents or venetoclax before.
- Subjects with acute panmyelosis with myelofibrosis or myeloid sarcoma defined by WHO 2016.
- Subjects with a prior history of MDS, MPN or MDS/MPN.
- Subjects with other concurrent malignant tumors on treatment with the exception of basal or squamous cell carcinoma of the skin,carcinoma in situ of the cervix, carcinoma in situ of the breast, incidental histologic finding of prostate cancerand need treatment.
- Pregnant or lactating women.
- Active heart disease, defined as anyone of the followings:(1) Uncontrolled or symptomatic angina pectoris;(2) A myocardial infarction 6 months before enrolled; (3)Arrhythmia needed medication or with severe clinical symptoms;(4)Uncontrolled or symptomatic congestive heart failure (NYHA\> grade 2);(5)Left ventricular ejection fraction below the lower limit of the normal range.
- Subjects with an active, uncontrolled, systemic fungal, bacterial, or viral infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment
- Subjects with an active viral infection caused by HIV, hepatitis B or hepatitis C virus that cannot be controlled by treatment.
- Subjects with evidence of central nervous system leukemia before treatment.
- Subjects with epilepsy which needs drug treatment, dementia, or other abnormal mental state that can't understand or follow the protocol.
- Conditions that limit the ingestion or gastrointestinal absorption of orally administered drugs.
Key Trial Info
Start Date :
May 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 15 2027
Estimated Enrollment :
312 Patients enrolled
Trial Details
Trial ID
NCT05356169
Start Date
May 19 2022
End Date
October 15 2027
Last Update
May 30 2025
Active Locations (1)
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1
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, China