NCT06451861RecruitingPhase 2
Randomized Study of ABC-14 Regimen Compared With "3+7" Standard Induction Therapy or AB-14 for ND AML
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
Source: ClinicalTrials.gov · Last updated 17 Nov 2025
Brief summary (registry, in English)
To compare the efficacy and safty of ABC-14 regimen with the traditional "3+7" regimen or AB-14 regimen in the treatment of newly diagnosed acute myeloid leukaemia
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 240 (estimated)
- First submitted
- 5 Feb 2024
- Start date
- 21 Aug 2024
- Primary completion date
- 30 Dec 2026
- Lead sponsor
- Guangdong Provincial People's Hospital
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT06451861
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 240
- From 21 Aug 2024 to the primary completion date, 30 Dec 2026
- 13 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Known history of allergy to the investigational drug;
- Inability to take oral medication;
Other illness
- Combined with uncontrolled active infections (including bacterial, fungal or viral infections);
- Combined with uncontrolled major organ dysfunction: cardiac insufficiency, decompensated liver insufficiency, moderate/severe renal insufficiency, etc.;
Other
- Resistance to azacytidine, azacitidine, Venetoclax;
- Participating in other clinical studies that affect the main purpose of this study; Patients deemed unsuitable for participation in this study.
Who the study is looking for
- 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);
- Age ≥18 years old;
- ECOG≤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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (13)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dongguan General Hosptial Coordinator of this site? Confirm its status | Dongguan | China | Recruiting |
| Foshan First People's Hospital Coordinator of this site? Confirm its status | Foshan | China | Recruiting |
| Guangdong Provincial People's Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| The First Affiliated Hospital of Jinan University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| The First Affiliated Hospital of Guangzhou Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| The Fifth Affiliated Hospital of Guangzhou Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| The First Affiliated Hospital of Guangdong Pharmaceutical University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Sun Yat-sen University Cancer Center Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| The second Affiliated Hospital of Guangzhou Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Hainan General Hosptial Coordinator of this site? Confirm its status | Haikou | China | Recruiting |
| Shenzhen Second People's Hospital Coordinator of this site? Confirm its status | Shenzhen | China | Recruiting |
| Affiliated Hospital of Guangdong Medical University Coordinator of this site? Confirm its status | Zhanjiang | China | Recruiting |
| Zhuhai General Hosptial Coordinator of this site? Confirm its status | Zhuhai | China | Recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.