Acute Myeloid LeukemiaPhase 2NCT06451861
Randomized Study of ABC-14 Regimen Compared With "3+7" Standard Induction Therapy or AB-14 for ND AML
A Phase 2 study testing Chidamide, Venetoclax and azacitidine in people with Acute Myeloid Leukemia, run by Guangdong Provincial People's Hospital at 13 sites in China.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Chidamide, Venetoclax and azacitidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 13 sitesChina
- Study dates
- 21 Aug 2024to 30 Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Known history of allergy to the investigational drug;
- Resistance to azacytidine, azacitidine, Venetoclax;
- Inability to take oral medication;
- 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.;
- Participating in other clinical studies that affect the main purpose of this study; Patients deemed unsuitable for participation in this study.
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
China13 sites, 13 recruiting
- Recruiting
Dongguan General Hosptial
Dongguan, Guangdong
yirong Jiang
- Recruiting
Foshan First People's Hospital
Foshan, Guangdong
Ying Zhao
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080
Xin Du
Jianyu WENG
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong
yang Liang
- Recruiting
The Fifth Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
Runhui Zheng
- Recruiting
The First Affiliated Hospital of Guangdong Pharmaceutical University
Guangzhou, Guangdong
xueyi Pan
- Recruiting
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
Zhenqian Huang
- Recruiting
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong
Liye Zhong
- Recruiting
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
xu Ye
- Recruiting
Hainan General Hosptial
Haikou, Hainan
Li'e Lin
- Recruiting
Shenzhen second people's Hospital
Shenzhen, Guangdong
xin Du
- Recruiting
Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong
Yuming ZHANG
- Recruiting
Zhuhai General Hosptial
Zhuhai, Guangdong
xiaoliang Li
About this study
Official title: 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
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
Read the detailed description
Acute myeloid leukemia (AML) is a clonal malignant blood disease with genetic heterogeneity and originated from hematopoietic stem progenitor cells.In the past 50 years, the "3+7" induction regimen represented by cytotoxic drugs (including anthracyclines/anthraquinones combined with cytarabine) has remained the standard induction regimen for newly diagnosed AML patients with intensive chemotherapy. In AML patients <60 years old, the "3+7" regimen induces a complete response rate of 60% to 80%, but the treatment-related mortality is as high as 13%, and more than half of the patients face the threat of relapse, and the 5-year overall survival rate is about 35% to 40%.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Chidamide, Venetoclax, azacitidine, Anthracyclines or anthraquinones, cytarabine
- Keywords
- ABC-14 regimen, "3+7" regimen, AB-14 regimen
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChidamideDrug
Induction Therapy
VenetoclaxDrug
Induction Therapy
azacitidineDrug
Induction Therapy
Anthracyclines or anthraquinonesDrug
Also called idarubicin, daunorubicin, mitoxantrone
Induction Therapy
cytarabineDrug
Induction Therapy
| Study group | Role | What they receive |
|---|---|---|
| ABC-14 regimen | Experimental | AZA,Venetoclax,Chidamide Receives: Drug: Chidamide; Drug: Venetoclax; Drug: azacitidine |
| 3+7 chemotherapy regimen | Active comparator | Daunorubicin/idarubicin/mitoxantrone and cytarabine Receives: Drug: Anthracyclines or anthraquinones; Drug: cytarabine |
| AB-14 regimen | Active comparator | AZA,Venetoclax Receives: Drug: Venetoclax; Drug: azacitidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite complete remission (CRc)
composite complete remission，CRc: CR + CRi + MLFS
Measured: 2 months
Secondary outcomes (5)
the rate of MRD turn negative
minimal residual disease turn negative
Measured: 6 months
DoR
Duration of remission
Measured: 2 year
RFS
Relapsed-free survival
Measured: 1 year
OS
Overall survival
Measured: 1 year
AE
Incidence of of grade 3-4 adverse events/Duration of severe myelosuppression/ Incidence of severe infection/Treatment-related mortality, according to Common Terminology Criteria for Adverse Events, versions 5.0
Measured: Throughout the study until the end, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start21 Aug 2024
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jianyu Weng, Principal investigator, Guangdong Provincial People Hosptial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06451861
- Sponsor's protocol ID
- ABC-14_101
- Status last verified
- Jun 2025
- First submitted
- 5 Feb 2024
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yan H, Huang X, Wu P, Deng C, Li M, Lai P, Du X, Weng J. Comparing the efficacy and safety of the ABC-14 regimen (azacitidine, venetoclax, and chidamide) with traditional "3 + 7" intensive induction regimen or AB-14 regimen (venetoclax combined with azacitidine) in newly diagnosed AML: study protocol for a prospective, multicenter, randomized, open-label clinical trial. Trials. 2025 Dec 10;27(1):38. doi: 10.1186/s13063-025-09339-y.
PubMed 41366419
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06451861
- Acronym / sponsor ID
- ABC-14_101
- Conditions
- Acute Myeloid Leukemia
- Keywords
- ABC-14 regimen, "3+7" regimen, AB-14 regimen
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- 21 Aug 2024 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 11 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Acute myeloid leukemia (AML) is a clonal malignant blood disease with genetic heterogeneity and originated from hematopoietic stem progenitor cells.In the past 50 years, the "3+7" induction regimen represented by cytotoxic drugs (including anthracyclines/anthraquinones combined with cytarabine) has remained the standard induction regimen for newly diagnosed AML patients with intensive chemotherapy. In AML patients <60 years old, the "3+7" regimen induces a complete response rate of 60% to 80%, but the treatment-related mortality is as high as 13%, and more than half of the patients face the threat of relapse, and the 5-year overall survival rate is about 35% to 40%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ABC-14 regimen | Experimental | Drug: Chidamide, Drug: Venetoclax, Drug: azacitidineAZA,Venetoclax,Chidamide |
| 3+7 chemotherapy regimen | Active comparator | Drug: Anthracyclines or anthraquinones, Drug: cytarabineDaunorubicin/idarubicin/mitoxantrone and cytarabine |
| AB-14 regimen | Active comparator | Drug: Venetoclax, Drug: azacitidineAZA,Venetoclax |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- Known history of allergy to the investigational drug;
- Resistance to azacytidine, azacitidine, Venetoclax;
- Inability to take oral medication;
- 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.;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChidamideInduction Therapy | Drug | ABC-14 regimen |
| VenetoclaxInduction Therapy | Drug | AB-14 regimen, ABC-14 regimen |
| azacitidineInduction Therapy | Drug | AB-14 regimen, ABC-14 regimen |
| Anthracyclines or anthraquinonesAlso: idarubicin, daunorubicin, mitoxantroneInduction Therapy | Drug | 3+7 chemotherapy regimen |
| cytarabineInduction Therapy | Drug | 3+7 chemotherapy regimen |
Primary outcome
Composite complete remission (CRc)
Time frame: 2 months
composite complete remission，CRc: CR + CRi + MLFS
5 secondary outcomes
the rate of MRD turn negative
Time frame: 6 months
DoR
Time frame: 2 year
RFS
Time frame: 1 year
OS
Time frame: 1 year
AE
Time frame: Throughout the study until the end, up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Derived from this study: PubMed 41366419Yan H, Huang X, Wu P, Deng C, Li M, Lai P, Du X, Weng J. Comparing the efficacy and safety of the ABC-14 regimen (azacitidine, venetoclax, and chidamide) with traditional "3 + 7" intensive induction regimen or AB-14 regimen (venetoclax combined with azacitidine) in newly diagnosed AML: study protocol for a prospective, multicenter, randomized, open-label clinical trial. Trials. 2025 Dec 10;27(1):38. doi: 10.1186/s13063-025-09339-y.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jianyu Weng principal investigator
Guangdong Provincial People Hosptial
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chidamide, Venetoclax and azacitidine in people with Acute Myeloid Leukemia, run by Guangdong Provincial People's Hospital at 13 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jianyu Weng (020-83827812, wengjianyu@gdph.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite complete remission (CRc) (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06451861, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.