ABC-14 versus standard "3+7" or AB-14 induction treatment for 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 is a randomized, phase 2 trial comparing an experimental ABC-14 induction regimen (including chidamide, venetoclax, and azacitidine together with conventional chemotherapy agents) to the traditional "3+7" regimen or AB-14 in adults with newly diagnosed non-APL AML. Eligible patients are treatment-naïve adults 18 years or older who meet organ function and performance status criteria and who can take oral medications. The study will measure remission rates, safety and treatment-related mortality to see if ABC-14 can improve outcomes over standard induction. It is being conducted at multiple centers in Guangdong province, China.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Diagnosed with AML (the diagnostic criteria refer to WHO2022 standard, non-APL), and have not received systemic anti-leukemia therapy (except hydroxyurea, low-dose cytarabine and other tumor reduction pretreatments);
2. Age ≥18 years old;
3. ECOG≤4;
4. The fertile woman agrees to use effective contraception during the treatment period and up to 3 months after the end of the treatment; Sign the informed consent form.

Exclusion Criteria:

1. Known history of allergy to the investigational drug;
2. Resistance to azacytidine, azacitidine, Venetoclax;
3. Inability to take oral medication;
4. Combined with uncontrolled active infections (including bacterial, fungal or viral infections);
5. Combined with uncontrolled major organ dysfunction: cardiac insufficiency, decompensated liver insufficiency, moderate/severe renal insufficiency, etc.;
6. Participating in other clinical studies that affect the main purpose of this study; Patients deemed unsuitable for participation in this study.

Where it's running

• Dongguan General Hosptial
  Dongguan, Guangdong, China Recruiting
• Foshan First People's Hospital
  Foshan, Guangdong, China Recruiting
• Guangdong Provincial People's Hospital
  Guangzhou, Guangdong, China Recruiting
• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting
• The Fifth Affiliated Hospital of Guangzhou Medical University
  Guangzhou, Guangdong, China Recruiting
• The First Affiliated Hospital of Guangdong Pharmaceutical University
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Principal investigator: Jianyu Weng — Guangdong Provincial People Hosptial
• Study coordinator: Jianyu Weng
• Email: wengjianyu@gdph.org.cn
• Phone: 020-83827812

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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.