VAC Regimen for AML Patients Who Failed to Response to VA Regimen

NCT06220162 | Recruiting Phase 2

• 1 other identifier: SZAML04
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Chidamide in combination with venetoclax and azacitidine (VAC) were expected to improve remission rate of patients following to VA regimen treatment failure.

Conditions

Acute Myeloid Leukemia

Keywords

AML venetoclax azacitidine chidamide unfit

Outcome Measures

Primary Outcomes (1)

• ORR(overall response rate)

  ORR was calculated as the sum of CR, CRi, MLFS and PR.

  1 month

Secondary Outcomes (3)

• OS (Overall survival)

  2 years

• EFS (Event-free survival)

  2 years

• Adverse events (AEs)

  2 months

Study Arms (1)

VAC regimen

EXPERIMENTAL

Drug: chidamide in combination with venetoclax and azacitidine (VAC)

Interventions

chidamide in combination with venetoclax and azacitidine (VAC) DRUG

Enrolled patients were given chidamide 10 mg every day on days 1-14, azacitidine 75mg/m2 every day on days 1-7, and oral venetoclax began at 100mg on day 1 and increased stepwise over 3 days to reach the target dose of 400mg (100mg, 200mg, and 400mg) on days 1-28. Dose adjustments for concomitant venetoclax with CYP3A4 inhibitors were made according to the literature.

VAC regimen

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with AML who are not suitable for intensive chemotherapy according to the WHO diagnosis: age ≥60 years or age \<60 years but fulfil the following criteria;
• Age 18 to 59 years;
• Eastern Cooperative Oncology Group (ECOG) physical status score of 2 or 3;
• Expected survival time ≥3 months;
• Or fulfilment of severe cardiac, pulmonary, hepatic, or renal disease; (A) Presence of a cardiac history of congestive heart failure, or ejection fraction ≤ 50%, or presence of chronic stable angina; (B) Lung carbon monoxide diffusing capacity (DLCO) ≤ 65%, or first forced expiratory volume (FEV1) ≤ 65%; (C) Moderate hepatic impairment with total bilirubin \> 1.5 to ≤ 3.0 x upper limit of normal (ULN); (D) Creatinine clearance ≥ 30 mL/min to \< 45 mL/min;
• Not received radiotherapy, treatment regimens other than the VA regimen, or haematopoietic stem cell transplantation within 4 weeks prior to enrolment;
• Other comorbidities that, in the judgement of the physician, make the administration of intensive chemotherapy unsuitable;
• Ability to understand and willingness to sign the informed consent for this trial;
• The patient refuses intensive chemotherapy and has the willingness to accept non-intensive chemotherapy.

You may not qualify if:

• Patients with a history of myeloproliferative neoplasms (MPN), including myelofibrosis, thrombocythemia, polycythaemia vera, chronic granulocytic leukemia (CML) with or without BCR-ABL1 translocation, and AML or acute promyelocytic leukemia (APL) with BCR-ABL1 translocation;
• Patients with less than 50% reduction of blasts after VA regimen;
• Patients with active CNS involvement;
• With prior treatment with chidamide;
• Clinically uncontrolled active infections (including bacterial, fungal or viral infections) and organ hemorrhage;
• Pregnant or lactating women;
• Participation in any other clinical trial within 3 months prior to VAC regimen;
• With other malignant tumours;
• With uncontrolled mental disorders;
• Any other condition that, in the opinion of the investigator, makes it inappropriate to participate in this trial.

Sponsors & Collaborators

• Jining Medical University: collaborator
• The Second People's Hospital of Huai'an: collaborator
• Northern Jiangsu People's Hospital: collaborator
• Affiliated Hospital of Nantong University: collaborator
• The First Affiliated Hospital of Soochow University: lead
• The First Affiliated Hospital of Bengbu Medical University: collaborator

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide; venetoclax; 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

• Sheng-Li Xue

  The First Affiliated Hospital of Soochow University

  STUDY CHAIR

Central Study Contacts

Sheng-Li Xue, M.D.

CONTACT

+8651267781139; slxue@suda.edu.cn

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: Prof.

Study Record Dates

• First Submitted: January 6, 2024
• First Posted: January 23, 2024
• Study Start: February 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)