Status:
UNKNOWN
Comparison of the Efficacy and Safety of Venetoclax in Combination With 3 Days Decitabine (DEC3-VEN) vs. Venetoclax in Combination With Azacitidine (VIALE-A) in the Treatment of Elderly Patients or Unfit, New-diagnosis Acute Myeloid Leukemia Patients
Lead Sponsor:
The Second Affiliated Hospital of Kunming Medical University
Conditions:
Elderly AML Patients
Unfit, New-diagnosis AML
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Combining the results of previous studies and based on the clinical practice in our center, we designed the Venetoclax in combination with 3days-Decitabine regimen for induction therapy in elderly or ...
Detailed Description
Induction therapy regimen: A: Experimental group: Venetoclax in combination with Decitabine (+-sorafenib) Venetoclax (VEN) 100mg d1, 200mg d2, 400mg d3-14 Decitabine (DEC) 20mg/m2/q8h, d4-6 (infusion...
Eligibility Criteria
Inclusion
- Subjects suitable for enrollment in this study must meet all of the following criteria.
- meet the World Health Organization diagnostic criteria (WHO2022 criteria) except APL or carry one of the abnormal karyotypes such as t(8;21)/(RUNX1::RUNX1TI), inv(16)(p13.1q22), t(16;16) (p13.1q22), t(16;16)/CBFβ::myh11), etc. Patients with acute myeloid leukemia other than those with one of the abnormal karyotypes such as t(16;16)/CBFβ::myh11
- Patients with AML not otherwise classified under the World Health Organization AML classification, except for acute myeloproliferative disorder with myelofibrosis and myeloid sarcoma.
- Male or female, A: Elderly patients aged \> or = 60 years (unwilling to undergo intense chemotherapy); B: Patients aged \> 18 years who are not candidates for standard-dose chemotherapy, defined as those with at least one of the following comorbidities: 1) Eastern Collaborative Oncology Group Physical Conditioning Grading (ECOG) score of 2 or 3; 2) Chronic heart failure (CHF) requiring treatment or with a left ventricular ejection fraction (LVEF) of ≤ 50%; 3) Chronic heart failure (CHF) requiring treatment or with a left ventricular ejection fraction (LVEF) of ≤ 50%. heart failure (CHF) cardiac history or chronic unstable angina; 3) carbon monoxide diffusing capacity (DLCO) ≤65% or forced expiratory volume in 1 second (FEV1) ≤65%; 4) creatinine clearance of ≥30 mL/min to ≤45 mL/min; and 5) any other condition deemed by the investigator to be incompatible with standard-dose chemotherapy must be reviewed with the study chair prior to study enrollment ;
- patients have not received prior treatment for AML (except hydroxyurea and Ara-C \<1.0 g/d).
- Eastern Cooperative Oncology Group Physical Status Assessment (ECOG-PS) score of \<=3.
- pass the requirements for the following laboratory test indices (performed within 7 days prior to treatment):
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- Aspartate aminotransferase (ALT), alanine aminotransferase (AST), and alkaline phosphatase (ALP) ≤ 3 x upper limit of normal (ULN), serum bilirubin ≤ 2 x ULN; and serum cardiac enzymes \< 2.0 x ULN; unless considered to be leukemic organ involvement.
- Creatinine ≥ 30 mL/min, calculated by the Cockcroft Gault formula or measured by 24-hour urine collection.
- Subjects of childbearing potential must have a negative pregnancy test result within 72 hours prior to the start of treatment, and participating patients must use contraception during trial treatment and for 3 years after completion of treatment.
- 8\. life expectancy greater than 2 months. 9. Informed consent must be signed prior to the start of all specific study procedures, either by the patient himself/herself or by a member of his/her immediate family; in view of the patient's condition, if the patient's own signature would not be conducive to the treatment of his/her condition, the informed consent will be signed by the legal guardian or by a member of the patient's immediate family.
Exclusion
- Subjects may not be enrolled in this study if they meet any of the following criteria:
- AML with BCR-ABL1; or CML bone marrow acute stage.
- Treatment-naïve patients (is defined as having received induction chemotherapy in the past, regardless of efficacy).
- Secondary leukemia (mainly refers to those whose World Health Organization (WHO) AML classification belongs to the subcategory of treatment-related AML and those with a history of prior MDS and/or MPD).
- concomitant other hematologic diseases (such as hemophilia, myelofibrosis and other investigators considered unsuitable for enrollment; previous blood abnormalities, but ever bone marrow examination except MDS and MPD allowed enrollment).
- 5、Pregnant or lactating patients. 6, Allergic to any of the drugs involved in this study. 7, Have used strong or moderate CYP7A inducers within 3 days before the start of study treatment.
- 8, Concomitant malignant tumors of other organs (those requiring treatment). 9, Significantly abnormal hepatic or renal function beyond the enrollment criteria.
- 10, Active heart disease, defined as one or more of the following:
- Myocardial infarction less than 6 months from study entry;
- A history of arrhythmia requiring drug therapy or severe clinical symptoms;
- Uncontrolled or symptomatic congestive heart failure (\> NYHA class 2); 10, patients with severe infectious diseases (untreated tuberculosis, pulmonary aspergillosis), known infection with human immunodeficiency virus (HIV) or active hepatitis B or C.
- 11\. Subjects with evidence of central nervous system leukemia prior to treatment.
- Subjects with epilepsy, dementia, or other abnormal mental states that require medication and who are unable to understand or follow the regimen.
- 13, Conditions that limit oral drug intake or gastrointestinal absorption. 14, Subjects who, in the opinion of the investigator, are not suitable for enrollment
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2025
Estimated Enrollment :
154 Patients enrolled
Trial Details
Trial ID
NCT06073730
Start Date
November 1 2023
End Date
November 1 2025
Last Update
October 10 2023
Active Locations (1)
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1
The Second Affiliated Hospital of Kunming Medical University.
Kunming, Yunnan, China