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

NCT06827899 | Recruiting Phase 2

• 1 other identifier: XMDYYYXYK-04
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

• Event-free survival (EFS)

  Defined as the time interval from treatment initiation to the occurrence of induction failure, relapse, or death, whichever came first.

  Up to 60 months

Secondary Outcomes (4)

• Complete Remission (CR) rate

  Up to 60 months

• Overall Survival (OS)

  Up to 60 months

• Overall Response Rate (ORR)

  Up to 60 months

• General Health Status/Quality of Life

  Up to 60 months

Study Arms (1)

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

EXPERIMENTAL

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

Interventions

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

Specified dose on specified days

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

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Xiamen University: lead
• Fujian Provincial Hospital: collaborator
• Fujian Cancer Hospital: collaborator
• Zhangzhou Affiliated Hospital of Fujian Medical University: collaborator
• Jieyang People's Hospital: collaborator
• Huizhou Municipal Central Hospital: collaborator

Study Sites (1)

Bing Xu

Xiamen, Fujian, 361000, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Azacitidine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Bing Xu

  The First Aiffiliated hosptical of xiamen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bing Xu

CONTACT

+8618750918842; xubingzhangjian@126.com

Zhifeng Li

CONTACT

+8613606901162; lzf_xm@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The First Affiliated Hospital of Xiamen University

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: February 14, 2025
• Study Start: July 1, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: February 20, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)