Treatment for elderly patients with newly diagnosed acute myeloid leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and efficacy of a treatment regimen combining Venetoclax, Chidamide, and Azacitidine (VCA) followed by a D-MAG regimen in elderly patients with newly diagnosed acute myeloid leukemia (AML). The approach aims to improve outcomes for patients who are unable to tolerate standard chemotherapy due to age or comorbidities. The study will involve administering two cycles of the VCA regimen followed by two cycles of the D-MAG regimen, with the goal of enhancing event-free survival. The regimen is designed to be more tolerable for elderly patients while aiming for higher complete response rates.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 1\) Histologically confirmed acute myeloid leukemia (non-M3). Treatment-na?ve and unable to receive standard cytarabine and anthracycline induction regimens due to age or comorbidities or patient preference.

  2\) Age ≥ 60 years old, male or female, with an expected survival more than 3 months.

  3\) Estimated creatinine clearance ≥ 30 mL/min. 4) AST and ALT ≤ 3.0 x ULN (unless leukemic organ involvement). Bilirubin ≤ 1.5 x ULN (unless considered due to leukemic organ involvement).

  5\) ECOG ≤ 2. 6) Able to understand and voluntarily provide informed consent.

Exclusion Criteria:

* 1)Acute promyelocytic leukemia (APL) and low risk cytogenetics such as t(8;21), inv(16) or t(16;16).

  2\) Active central nervous system leukemia. 3) History of myeloproliferative neoplasm (MPN) including myelofibrosis, essential thrombocythemia, polycythemia vera, chronic myeloid leukemia (CML) with or without BCR-ABL1 translocation and AML with BCR- ABL1 translocation.

  4\) HIV positive patients and/or HBV or HCV active infection (documented by HBV-DNA and HCV-RNA positive test) 5) Patients suffering from chronic respiratory diseases that require continuous oxygen inhalation, or a history of obvious renal, nervous system, psychiatric, endocrine, metabolic, immune, liver, and cardiovascular diseases 6) Patients suffering from malabsorption syndrome or other conditions that exclude enteral route of administration.

  7\) Patients has clinically significant QTc prolongation (\>450 ms in men; \>470 ms in women), ventricular tachycardia and atrial fibrillation, second-degree heart block, myocardial infarction within the year prior to enrollment, and congestive heart failure;and patients with coronary heart disease with clinical symptoms requiring drug treatment.

  8\) Active, uncontrolled severe infection. 9) History of other malignancies within 2 years, except for the following: Adequately treated cervix or breast cancer in situ; Basal cell cancer or local squamous cell carcinoma of the skin; 10) White blood cell count \> 25 × 10\^9/L. (Hydroxyurea or leukapheresis may meet this criterion.) 11) Mental disorders that hinder research participation 12) Participants have received the following treatments: hypomethylating agents, veneclax and/or chemotherapy for myelodysplastic syndrome (MDS), solid organ transplantation.

  13\) Any other circumstances that the investigator believes that the patient is not suitable to participate in this trial

Where it's running

• Bing Xu
  Xiamen, Fujian, China Recruiting

Study contacts

• Principal investigator: Bing Xu, M.D. — The First Affiliated Hospital of Xiamen University
• Study coordinator: Bing Xu, M.D.
• Email: xubingzhangjian@126.com
• Phone: +865922137255

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.