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

Recruiting now · Phase 2

Conditions studied: Acute Myeloid Leukemia

In brief

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

Key facts

Study ID

NCT06220162

Run by

The First Affiliated Hospital of Soochow University

People needed

32

Starts

2024-02-01

Expected to finish

2026-12-01

Last updated by the study team

2026-03-19

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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 FLT3 mutations and who were treated with targeted agents (inclusion is possible if the use of specific targeted agents is discontinued);
• 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.

Where it is running

• The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (enrolling)

Full record on ClinicalTrials.gov

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