Combination treatment for elderly patients with untreated 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 clinical trial investigates the effectiveness of a combination treatment involving veneclax, chidaniline, and azacitidine, followed by a regimen of decitabine and MAG in elderly patients diagnosed with untreated acute myeloid leukemia (AML). It is a multicenter, prospective, single-arm study designed to assess the safety and efficacy of this novel treatment approach. The trial aims to provide an alternative for patients who cannot undergo standard chemotherapy due to age or other health conditions. Participants will be closely monitored for treatment response and side effects throughout the study.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 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;
2. Age \>= 60 years old, male or female, expected survival time greater than 3 months;
3. Estimated creatinine clearance \>= 30 mL/min;
4. 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);
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. 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;
4. HIV-positive patients and/or HBV or HCV active infection (documented by HBV-DNA and HCV-RNA positive tests);
5. 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;
6. Suffering from malabsorption syndrome or other diseases that exclude the enteral route of administration;
7. 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;
8. Active, uncontrolled severe infection;
9. 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;
10. White blood cell count \> 25 x 10\^9/L (hydroxyurea or leukapheresis can meet this standard);
11. Mental disorders that will hinder research participation;
12. Participants have received the following treatments: hypomethylation agents, venetoclax 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 — The First Aiffiliated hosptical of xiamen University
• Study coordinator: Bing Xu
• Email: xubingzhangjian@126.com
• Phone: +8618750918842

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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.