New treatment for AML patients who didn't respond to initial therapy

A Clinical Study of Chidamide in Combination With Venetoclax and Azacitidine (VAC) for Patients With Acute Myeloid Leukemia Who Did Not Achieve CR/CRi/MLFS (PR or NR) With One Cycle of Venetoclax and Azacitidine (VA).

This study is testing a new combination treatment for older patients or younger patients with certain health issues who have Acute Myeloid Leukemia and didn't get better with standard therapy, to see if it can help them go into remission.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: The First Affiliated Hospital of Soochow University (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Suzhou, Jiangsu)
• Trial ID: NCT06220162 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of chidamide combined with venetoclax and azacitidine (VAC) in patients with Acute Myeloid Leukemia (AML) who did not achieve remission after the standard VA regimen. The study aims to improve remission rates by targeting the expression of MCL, which may enhance the efficacy of the existing treatment. Eligible participants include elderly patients or younger patients with specific health conditions that make them unsuitable for intensive chemotherapy. The trial is conducted in a Phase 2 setting to evaluate the safety and effectiveness of this new combination therapy.

Who should consider this trial

Good fit: Ideal candidates are AML patients aged 18 and older who are not suitable for intensive chemotherapy due to age or specific health conditions.

Not a fit: Patients who have received radiotherapy or other treatment regimens outside of the VA regimen within the last four weeks may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve remission rates for AML patients who have not responded to previous therapies.

How similar studies have performed: While the combination of venetoclax and azacitidine has shown promise in previous studies, the addition of chidamide represents a novel approach that has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

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;

1. Age 18 to 59 years;
2. Eastern Cooperative Oncology Group (ECOG) physical status score of 2 or 3;
3. Expected survival time ≥3 months;
4. 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;
5. Not received radiotherapy, treatment regimens other than the VA regimen, or haematopoietic stem cell transplantation within 4 weeks prior to enrolment;
6. Other comorbidities that, in the judgement of the physician, make the administration of intensive chemotherapy unsuitable;
7. Ability to understand and willingness to sign the informed consent for this trial;
8. The patient refuses intensive chemotherapy and has the willingness to accept non-intensive chemotherapy.

Exclusion Criteria:

1. 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;
2. Patients with FLT3 mutations and who were treated with targeted agents (inclusion is possible if the use of specific targeted agents is discontinued);
3. Patients with less than 50% reduction of blasts after VA regimen;
4. Patients with active CNS involvement;
5. With prior treatment with chidamide;
6. Clinically uncontrolled active infections (including bacterial, fungal or viral infections) and organ hemorrhage;
7. Pregnant or lactating women;
8. Participation in any other clinical trial within 3 months prior to VAC regimen;
9. With other malignant tumours;
10. With uncontrolled mental disorders;
11. Any other condition that, in the opinion of the investigator, makes it inappropriate to participate in this trial.

Where this trial is running

Suzhou, Jiangsu

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

Study contacts

• Study coordinator: Sheng-Li Xue, M.D.

Conditions: Acute Myeloid Leukemia, AML venetoclax azacitidine chidamide unfit