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Recruiting NCT06827899

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

Phase II Interventional Acute Myeloid Leukemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: veneclax, chidaniline combined with azacitidine (VCA) followed by decitabine + MAG regimen (D-MAG).
Who it may be relevant to
Registry conditions: Acute Myeloid Leukemia. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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)

Overview

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)

Detailed description

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)

Interventions

  • Drug veneclax, chidaniline combined with azacitidine (VCA) followed by decitabine + MAG regimen (D-MAG)
    Specified dose on specified days

Primary outcome measures

  • Event-free survival (EFS) [Time frame: Up to 60 months]
Secondary outcome measures (4)
  • Complete Remission (CR) rate [Time frame: Up to 60 months]
  • Overall Survival (OS) [Time frame: Up to 60 months]
  • Overall Response Rate (ORR) [Time frame: Up to 60 months]
  • General Health Status/Quality of Life [Time frame: Up to 60 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Bing Xu — Xiamen

Identifiers

NCT: NCT06827899 · XMDYYYXYK-04

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗