ABC-14 versus standard "3+7" or AB-14 induction treatment for newly diagnosed acute myeloid leukemia

Randomized Study of ABC-14 Regimen ( AZA, Venetoclax and Chidamide) Compared With "3+7" Standard Induction Therapy or AB-14 (Venetoclax Combined With Azacitidine) for Newly Diagnosed Acute Myeloid Leukemia

This trial tests whether the ABC-14 combination works better and is safer than the standard "3+7" or AB-14 regimens for adults newly diagnosed with acute myeloid leukemia.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 240 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Guangdong Provincial People's Hospital (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 13 sites (Dongguan, Guangdong and 12 other locations)
• Trial ID: NCT06451861 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (≥18) with newly diagnosed non-APL AML who have not received prior systemic anti-leukemia therapy (aside from limited cytoreduction), have acceptable performance status and organ function, can take oral medications, and consent to the trial.

Not a fit: Patients with acute promyelocytic leukemia (APL), prior systemic AML treatment, known resistance to azacitidine or venetoclax, uncontrolled active infections or major organ dysfunction, or inability to take oral drugs are unlikely to benefit from this regimen.

Why it matters

Potential benefit: If successful, ABC-14 could increase initial remission rates and/or lower treatment-related mortality compared with standard induction regimens.

How similar studies have performed: Combinations of venetoclax with hypomethylating agents like azacitidine have shown promising results in AML, but adding chidamide and the specific ABC-14 formulation is a relatively novel approach with limited prior data.

Eligibility criteria

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 this trial is running

Dongguan, Guangdong and 12 other locations

• 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)
• The First Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (Recruiting)
• The First Affiliated Hospital of Jinan University — Guangzhou, Guangdong, China (Recruiting)
• The Second Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (Recruiting)
• Shenzhen second people's Hospital — Shenzhen, Guangdong, China (Recruiting)
• Affiliated Hospital of Guangdong Medical University — Zhanjiang, Guangdong, China (Recruiting)
• Zhuhai General Hosptial — Zhuhai, Guangdong, China (Recruiting)
• Hainan General Hosptial — Haikou, Hainan, China (Recruiting)

Study contacts

• Principal investigator: Jianyu Weng — Guangdong Provincial People Hosptial
• Study coordinator: Jianyu Weng

Conditions Acute Myeloid Leukemia; ABC-14 regimen; "3+7" regimen; AB-14 regimen