Veneclax, Chidaniline Combined With Azacitidine Followed by Decitabine + MAG Regimen in the Treatment of Elderly Untreated AML

Xiamen University

Status and phase

Enrolling

Phase 2

Conditions

Acute Myeloid Leukemia

Treatments

Drug: veneclax, chidaniline combined with azacitidine (VCA) followed by decitabine + MAG regimen (D-MAG)

Study type

Interventional

Funder types

Other

Identifiers

NCT06827899

XMDYYYXYK-04

Details and patient eligibility

About

A multicenter, prospective, single-arm clinical study of veneclax, chidaniline combined with azacitidine (VCA) followed by decitabine + MAG regimen (D-MAG) in the treatment of elderly untreated acute myeloid leukemia (AML)

Full description

Enrollment

66 estimated patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Histologically confirmed acute myeloid leukemia (non-M3). Have not received treatment before and cannot accept standard cytarabine and anthracycline induction regimen treatment due to age or comorbidity or patient preference;
Age >= 60 years old, male or female, expected survival time greater than 3 months;
Estimated creatinine clearance >= 30 mL/min;
AST and ALT <= 3.0 x ULN (unless considered due to leukemic organ involvement). Bilirubin <= 1.5 x ULN (unless considered due to leukemic organ involvement);
ECOG <= 2;
Able to understand and voluntarily provide informed consent.

Exclusion criteria

Acute promyelocytic leukemia (APL) and low-risk cytogenetics, such as t(8;21), inv(16), or t(16;16);
Active central nervous system leukemia;
A history of myeloproliferative neoplasms (MPN), including myelofibrosis, essential thrombocythemia, polycythemia vera, chronic myelogenous leukemia (CML) with or without BCR-ABL1 translocation and AML with BCR- ABL1 translocation;
HIV-positive patients and/or HBV or HCV active infection (documented by HBV-DNA and HCV-RNA positive tests);
Suffering from chronic respiratory diseases requiring continuous oxygen inhalation, or having an obvious history of kidney, nervous system, psychiatric, endocrine, metabolic, immune, liver, and cardiovascular diseases;
Suffering from malabsorption syndrome or other diseases that exclude the enteral route of administration;
Clinically significant QTc interval prolongation (male > 450 ms; female > 470 ms), ventricular tachycardia and atrial fibrillation, second-degree heart block, myocardial infarction, and congestive heart failure within one year before enrollment patients, and patients with coronary heart disease who have clinical symptoms and need drug treatment;
Active, uncontrolled severe infection;
There is a history of other malignant tumors within 2 years, except for the following cases: adequately treated carcinoma in situ of the cervix or carcinoma in situ of the breast; basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin;
White blood cell count > 25 x 10^9/L (hydroxyurea or leukapheresis can meet this standard);
Mental disorders that will hinder research participation;
Participants have received the following treatments: hypomethylation agents, venetoclax and/or chemotherapy for myelodysplastic syndrome (MDS), solid organ transplantation;
Any other circumstances that the investigator believes that the patient is not suitable to participate in this trial.