Acute Myeloid Leukemia, AdultPhase 2NCT06532552
Comparison of VA (Venetoclax, Azacitidine), VACl (VA, Cladribine), VACh (VA, Chidamide), and Alternating VACl/VACh in Newly Diagnosed Acute Myeloid Leukemia
A Phase 2 study testing VACl, VACh and VACl Alternating With VACh in people with Acute Myeloid Leukemia, Adult and Newly Diagnosed, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
This prospective, multi-center, randomized, controlled Phase II study is to compare the therapeutic efficacy and side effect of VACl (Venetoclax,Azacitidine,Cladribine) alternating with VACh (Venetoclax,Azacitidine,Chidamide), VACl, VACh and VA in newly diagnosed adult acute myeloid leukemia (AML) patients ineligible… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia, Adult, Newly Diagnosed
- What is being tested?
- VACl, VACh and VACl Alternating With VACh
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteChina
- Study dates
- 29 Jul 2024to 1 Aug 2028
- 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
- A subject will be eligible for study participation if he/she meets the following criteria within 21 days prior to randomization.
- Subject must have confirmation of previously untreated AML by World Health Organization (WHO) criteria, and be ineligible for treatment with a standard cytarabine and anthracycline induction regimen due age or comorbidities. Prior therapy with hydroxyurea or a total dose of cytarabine no more than 0.5g (for emergency use for stabilization) is allowed.
- Subject must be≥18 years of age with at least one of the following conditions:
- A)≥60 years of age; B) Patients aged < 60 years who are unsuitable for standard induction therapy（Any other comorbidity that the physician judges to be incompatible with conventional intensive chemotherapy); C) The patient refused the conventional intensive chemotherapy.
- Adequate organ function as defined below:
- A)liver function (bilirubin≤2mg/dL, aspartate transaminase (AST) and/or alanine transaminase (ALT)≤3 x ULN).
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- Unless liver enzyme abnormalities are determined by the treating MD and PI to be due to leukemic infiltration.
- B)kidney function (creatinine≤1.5xULN ).
- ECOG performance status of ≤ 2.
- A negative urine pregnancy test is required within 1 week for all women of childbearing potential prior to enrolling on this trial.
- Patient must have the ability to understand the requirements of the study and signed informed consent. A signed informed consent by the patient or his legally authorized representative is required prior to their enrollment on the protocol.
- Patient must have a projected life expectancy of at least 12 weeks.
Who cannot join
- Subject has a history of other malignancies prior to study entry, with the exception of:
- Adequately treated in situ carcinoma of the cervix uteri or carcinoma in situ of breast; B) Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin; C) Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent.
- Subject has acute promyelocytic leukemia, subject has history of myeloproliferative neoplasm [MPN] including myelofibrosis, essential thrombocythemia, polycythemia vera, CML with or without BCR-ABL1 translocation, BCR/ABL positive AML.
- Patient has known active central nervous syster (CNS) involvement with AML.
- Subject has a white blood cell count> 25×10^9/L. (Hydroxyurea is permitted to meet this criterion.)
- Prior therapy with venetoclax, Cladribine, hypomethylating agents (HMAs), Chidamide or Chimeric Antigen Receptor T cell therapy, experimental therapies for MDS or AML.
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- Subject has a malabsorption syndrome or other condition that precludes enteral route of administration.
- Subject is known to be positive for human immunodeficiency virus (HIV) (HIV testing is not required.)
- Subject has received strong and/or moderate CYP3A inducers within 7 days prior to the initiation of study treatment.
- Subject has consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or Starfruit within 3 days prior to the initiation of study treatment.
- Subject has a cardiovascular disability status of New York Heart Association Class≥2. Class 2 is defined as cardiac disease in which patients are comfortable at rest but ordinary physical activity results in fatigue, palpitations, dyspnea, or anginal pain.
- Subject has chronic respiratory disease that requires continuous oxygen, or significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, hepatic, cardiovascular disease, or any other medical condition that in the opinion of the investigator would adversely affect his/her participating in this study.
- Subject exhibits evidence of other clinically significant uncontrolled systemic infection requiring therapy (viral, bacterial or fungal).
- Subject is known to be positive for hepatitis B or C infection with the exception of those with an undetectable viral load within 3 months (Hepatitis B or C testing is not required). Subjects with serologic evidence of prior vaccination to HBV [i.e., HBs Ag-, and anti-HBs+-] may participate)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
Sheng-Li Xue, M.D., +8651267781139, slxue@suda.edu.cn
About this study
Official title: Comparison of VA (Venetoclax, Azacitidine), VACl (VA, Cladribine), VACh (VA, Chidamide), and Alternating VACl/VACh in Newly Diagnosed Adult Acute Myeloid Leukemia Patients Ineligible for Intensive Therapy or Declining: A Prospective, Multi-center, Randomized, Controlled Phase II Study
This prospective, multi-center, randomized, controlled Phase II study is to compare the therapeutic efficacy and side effect of VACl (Venetoclax,Azacitidine,Cladribine) alternating with VACh (Venetoclax,Azacitidine,Chidamide), VACl, VACh and VA in newly diagnosed adult acute myeloid leukemia (AML) patients ineligible for intensive therapy or declining. Cladribine is a purine analogue widely used in hematologic malignancies. The monocytic leukemia stem cell is selective sensitivity to Cladribine. Chidamide, a newly designed selective histone deacetylase inhibitor, could down regulate myeloid cell leukaemia 1 (MCL1) expression in Venetoclax resistant AML cells. Chidamide or Cladribine have synergistic anti-leukemia effects with VA through their unique mechanisms, which can eradicate leukemia stem cells and prevent the occurrence of drug resistance.
Read the detailed description
AML is a clonal myelopoietic stem cell disorder characterized by the accumulation of neoplastic cells in the bone marrow and in the peripheral circulation. The median age of AML patients is 68 years. Although intensive chemotherapy and allogeneic stem cell transplant (allo-HSCT) are standard approaches for newly diagnosed patients, they are associated with higher rates of treatment related complications and inferior outcomes in older patients. Venetoclax, a newly orally available and selective B cell lymphoma-2 (BCL2) inhibitor, Venetoclax in combination with hypomethylation agents or cytarabine has been approved by the Food and Drug Administration (FDA) for the treatment of patients with newly diagnosed AML unfit for intensive chemotherapy. However, the emergence of resistance to Venetoclax based combinations has become an important clinical dilemma. Resistance to Venetoclax can be acquired through the up regulation of anti-apoptotic proteins, such as myeloid cell leukaemia 1 (MCL1). Chidamide, a newly designed selective histone deacetylase inhibitor, Chidamide could down Bregulate MCL1 expression in Venetoclax resistant AML cells. Our experience showed that the Chidamide+VA could improve the condition of R/R AML patients who are resistant to VA. Cladribine is a purine analogue widely used in hematologic malignancies. It was demonstrated that addition of Cladribine to the VA regimen increases eradication of primary AML containing monocytic leukemia stem cell activity in both in vitro and in vivo preclinical models. Chidamide or Cladribine have synergistic anti-leukemia effects with VA through their unique mechanisms, which can eradicate leukemia stem cells and prevent the occurrence of drug resistance, thereby increasing response rate, prolonging patient survival, reducing recurrence, and improving prognosis without increasing treatment-related complications. Therefore, this prospective, multi-center, randomized, controlled Phase II study is to compare the therapeutic efficacy and side effect of VACl (Venetoclax,Azacitidine,Cladribine) alternating with VACh (Venetoclax,Azacitidine,Chidamide), VACl, VACh and VA in newly diagnosed adult AML patients ineligible for intensive therapy or declining.
- Conditions
- Acute Myeloid Leukemia, Adult, Newly Diagnosed
- Being tested
- VACl, VACh, VACl Alternating With VACh, VA
- Keywords
- Venetoclax, Azacitidine, Cladribine, Chidamide
- 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.
VAClDrug
Also called Venetoclax+Azacitidine+Cladribine
Azacitidine:75mg/m2 Subcutaneous daily for 7 days Venetoclax: orally once daily (100 mg d1, 200mg d2, 400mg d3-28) Cladribine: 5mg/m2 IV over approximately 1 to 2 hours, daily on days 1-3.
VAChDrug
Also called Venetoclax+Azacitidine+Chidamide
Azacitidine: 75mg/m2 Subcutaneous daily for 7 days Venetoclax: orally once daily (100mg d1, 200mg d2, 400mg d3-28) Chidamide: 10mg orally daily for 12 days
VACl Alternating With VAChDrug
Also called Venetoclax+Azacitidine+Cladribine alternating with Venetoclax+Azacitidine+Chidamide
VACl:
Azacitidine:75mg/m2 Subcutaneous daily for 7 days Venetoclax: orally once daily (100 mg d1, 200mg d2, 400mg d3-28) Cladribine: 5mg/m2 IV over approximately 1 to 2 hours, daily on days 1-3.
VACh:
Azacitidine: 75mg/m2 Subcutaneous daily for 7 days Venetoclax: orally once daily (100mg d1, 200mg d2, 400mg d3-28) Chidamide: 10mg orally daily for 12 days
VADrug
Also called Venetoclax+Azacitidine
Azacitidine: 75mg/m2 Subcutaneous (SC) daily for 7 days Venetoclax: orally once daily (100mg d1, 200mg d2, 400mg d3-28).
| Study group | Role | What they receive |
|---|---|---|
| VA group | Active comparator | Azacitidine 75mg/m2 subcutaneous daily for 7 days and Venetoclax orally once daily (100mg d1, 200mg d2, 400mg d3-28). Patients received 2 cycles of VA, the bone marrow aspirate will be done on the 21-28th day in the each cycle. If the result is partial remission (PR)/no response (NR) at the end of the cycle 2, the patients need to withdraw from the trial. If the bone marrow assessment is complete remission (CR)/CR with incomplete hematologic recovery (CRi)/morphologic leukemia-free state (MLFS), the patients will start post-remission therapy. For post-remission therapy, if the patients ineligible for intensive chemotherapy or declines, continue with the same regimen until progression or recurrence of the disease, and the patients need to withdraw from the trial. If the patients fit for intensive chemotherapy, patients will receive chemotherapy with other regimens or transplantation, and the patients need to withdraw from the trial if progression or recurrence of the disease. Receives: Drug: VA |
| VACl group | Experimental | Azacitidine 75mg/m2 subcutaneous Daily for 7 days, Venetoclax orally once daily (100 mg d1, 200mg d2, 400mg d3-28) and Cladribine 5mg/m2 intravenous (IV) over approximately 1 to 2 hours, daily on days 1-3. Patients received 2 cycles of VACl treatments, the bone marrow aspirate will be done on the 21-28th day in the each cycle. If the bone marrow assessment is PR/NR at the end of the cycle 2, the patients need to withdraw from the trial. If the bone marrow assessment is CR/CRi/MLFS, the patients will start post-remission therapy. For post-remission therapy, if the patients ineligible for intensive chemotherapy or declines, continue with the same regimen until progression or recurrence of the disease, and the patients need to withdraw from the trial. If the patients fit for intensive chemotherapy, patients will receive consolidation chemotherapy with other regimens or transplantation, and the patients need to withdraw from the trial if progression or recurrence of the disease. Receives: Drug: VACl |
| VACh group | Experimental | Azacitidine 75mg/m2 subcutaneous daily for 7 days, Venetoclax orally once daily (100mg d1, 200mg d2, 400mg d3-28) and Chidamide 10mg orally daily for 12 days. Patients received 2 cycles of VACh treatments, the bone marrow aspirate will be done on the 21-28th day in the each cycle. If the bone marrow assessment is PR/NR at the end of the cycle 2, the patients need to withdraw from the trial. If the bone marrow assessment is CR/CRi/MLFS, the patients will start post-remission therapy. For post-remission therapy, if the patients ineligible for intensive chemotherapy or declines, continue with the same regimen until progression or recurrence of the disease, and the patients need to withdraw from the trial. If the patients fit for intensive chemotherapy, patients will receive consolidation chemotherapy with other regimens or transplantation, and the patients need to withdraw from the trial if progression or recurrence of the disease. Receives: Drug: VACh |
| VACl Alternating With VACh group | Experimental | Patients received 1 cycle of VACl and 1 cycle of VACh treatment, the bone marrow aspirate will be done on the 21-28th day in the each cycle. If the bone marrow assessment is PR/NR at the end of the cycle 2, the patients need to withdraw from the trial. If the bone marrow assessment is CR/CRi/MLFS, the patients will start post-remission therapy. For post-remission therapy, if the patients ineligible for intensive chemotherapy or declines, continue with the VACl alternating with VACh until progression or recurrence of the disease, and the patients need to withdraw from the trial. If the patients fit for intensive chemotherapy, patients will receive consolidation chemotherapy with other regimens or transplantation, and the patients need to withdraw from the trial if progression or recurrence of the disease. Receives: Drug: VACl Alternating With VACh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free survival (EFS)
It is defined as the number of days from the date of randomization to the date of earliest evidence of relapse, subsequent treatment other than stem cell transplant while in composite complete remission (CR+CRi), or death. If the specified event (relapse, start of subsequent treatment, or death) does not occur, subjects will be censored at the date of last disease assessment.
Measured: 1 year
Cumulative incidence of relapse (CIR)
Time from CR to disease recurrence or progression
Measured: 1 year
Secondary outcomes (4)
Composite complete response (CRc)
CRc rate was defifined as patients achieving a CR or CRi
Measured: At the end of Cycle 1 (each cycle is 21-28 days)
Overall Survival (OS)
Time from date of treatment start until date of death due to any cause
Measured: 1 year
Adverse reactions in hematology
Record of adverse events in hematological system during and after VA,VACl,VACh,VACl alternating with VACh regimen induction (agranulocytosis days, platelet（PLT）/red blood cell (RBC) transfusion units)
Measured: At the end of Cycle 1 (each cycle is 21-28 days)
Nonhematological adverse reactions
Record of adverse events in other organs or systmes during and after VA,VACl,VACh,VACl alternating with VACh regimen induction (infection and organ injury)
Measured: At the end of Cycle 1 (each cycle is 21-28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start29 Jul 2024
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid Leukemia, AdultStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow UniversityThe sponsor's other registered studies.
- 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
- 172 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Jining Medical University, Qilu Hospital of Shandong University, The Affiliated Hospital of Qingdao University, The First Affiliated Hospital of Anhui Medical University, Tongji Hospital, The First Affiliated Hospital of Bengbu Medical University
- Responsible party
- Principal investigator, Sheng-Li Xue, MD, The First Affiliated Hospital of Soochow University
- Investigators
- Sheng-Li Xue, M.D., Principal investigator, The First Affliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06532552
- Sponsor's protocol ID
- SZAML06
- Status last verified
- Nov 2025
- First submitted
- 29 Jul 2024
- Last updated
- 19 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of VA (Venetoclax, Azacitidine), VACl (VA, Cladribine), VACh (VA, Chidamide), and Alternating VACl/VACh in Newly Diagnosed Adult Acute Myeloid Leukemia Patients Ineligible for Intensive Therapy or Declining: A Prospective, Multi-center, Randomized, Controlled Phase II Study
- ClinicalTrials.gov ID
- NCT06532552
- Acronym / sponsor ID
- SZAML06
- Conditions
- Acute Myeloid Leukemia, Adult, Newly Diagnosed
- Keywords
- Venetoclax, Azacitidine, Cladribine, Chidamide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Collaborators
- Jining Medical University, Qilu Hospital of Shandong University, The Affiliated Hospital of Qingdao University, The First Affiliated Hospital of Anhui Medical University, Tongji Hospital, The First Affiliated Hospital of Bengbu Medical University
- Study start
- 29 Jul 2024 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 1 Aug 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.
This prospective, multi-center, randomized, controlled Phase II study is to compare the therapeutic efficacy and side effect of VACl (Venetoclax,Azacitidine,Cladribine) alternating with VACh (Venetoclax,Azacitidine,Chidamide), VACl, VACh and VA in newly diagnosed adult acute myeloid leukemia (AML) patients ineligible for intensive therapy or declining. Cladribine is a purine analogue widely used in hematologic malignancies. The monocytic leukemia stem cell is selective sensitivity to Cladribine. Chidamide, a newly designed selective histone deacetylase inhibitor, could down regulate myeloid cell leukaemia 1 (MCL1) expression in Venetoclax resistant AML cells. Chidamide or Cladribine have synergistic anti-leukemia effects with VA through their unique mechanisms, which can eradicate leukemia stem cells and prevent the occurrence of drug resistance.
Detailed description
AML is a clonal myelopoietic stem cell disorder characterized by the accumulation of neoplastic cells in the bone marrow and in the peripheral circulation. The median age of AML patients is 68 years. Although intensive chemotherapy and allogeneic stem cell transplant (allo-HSCT) are standard approaches for newly diagnosed patients, they are associated with higher rates of treatment related complications and inferior outcomes in older patients. Venetoclax, a newly orally available and selective B cell lymphoma-2 (BCL2) inhibitor, Venetoclax in combination with hypomethylation agents or cytarabine has been approved by the Food and Drug Administration (FDA) for the treatment of patients with newly diagnosed AML unfit for intensive chemotherapy. However, the emergence of resistance to Venetoclax based combinations has become an important clinical dilemma. Resistance to Venetoclax can be acquired through the up regulation of anti-apoptotic proteins, such as myeloid cell leukaemia 1 (MCL1). Chidamide, a newly designed selective histone deacetylase inhibitor, Chidamide could down Bregulate MCL1 expression in Venetoclax resistant AML cells. Our experience showed that the Chidamide+VA could improve the condition of R/R AML patients who are resistant to VA. Cladribine is a purine analogue widely used in hematologic malignancies. It was demonstrated that addition of Cladribine to the VA regimen increases eradication of primary AML containing monocytic leukemia stem cell activity in both in vitro and in vivo preclinical models. Chidamide or Cladribine have synergistic anti-leukemia effects with VA through their unique mechanisms, which can eradicate leukemia stem cells and prevent the occurrence of drug resistance, thereby increasing response rate, prolonging patient survival, reducing recurrence, and improving prognosis without increasing treatment-related complications. Therefore, this prospective, multi-center, randomized, controlled Phase II study is to compare the therapeutic efficacy and side effect of VACl (Venetoclax,Azacitidine,Cladribine) alternating with VACh (Venetoclax,Azacitidine,Chidamide), VACl, VACh and VA in newly diagnosed adult AML patients ineligible for intensive therapy or declining.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| VA group | Active comparator | Drug: VAAzacitidine 75mg/m2 subcutaneous daily for 7 days and Venetoclax orally once daily (100mg d1, 200mg d2, 400mg d3-28). Patients received 2 cycles of VA, the bone marrow aspirate will be done on the 21-28th day in the each cycle. If the result is partial remission (PR)/no response (NR) at the end of the cycle 2, the patients need to withdraw from the trial. If the bone marrow assessment is complete remission (CR)/CR with incomplete hematologic recovery (CRi)/morphologic leukemia-free state (MLFS), the patients will start post-remission therapy. For post-remission therapy, if the patients ineligible for intensive chemotherapy or declines, continue with the same regimen until progression or recurrence of the disease, and the patients need to withdraw from the trial. If the patients fit for intensive chemotherapy, patients will receive chemotherapy with other regimens or transplantation, and the patients need to withdraw from the trial if progression or recurrence of the disease. |
| VACl group | Experimental | Drug: VAClAzacitidine 75mg/m2 subcutaneous Daily for 7 days, Venetoclax orally once daily (100 mg d1, 200mg d2, 400mg d3-28) and Cladribine 5mg/m2 intravenous (IV) over approximately 1 to 2 hours, daily on days 1-3. Patients received 2 cycles of VACl treatments, the bone marrow aspirate will be done on the 21-28th day in the each cycle. If the bone marrow assessment is PR/NR at the end of the cycle 2, the patients need to withdraw from the trial. If the bone marrow assessment is CR/CRi/MLFS, the patients will start post-remission therapy. For post-remission therapy, if the patients ineligible for intensive chemotherapy or declines, continue with the same regimen until progression or recurrence of the disease, and the patients need to withdraw from the trial. If the patients fit for intensive chemotherapy, patients will receive consolidation chemotherapy with other regimens or transplantation, and the patients need to withdraw from the trial if progression or recurrence of the disease. |
| VACh group | Experimental | Drug: VAChAzacitidine 75mg/m2 subcutaneous daily for 7 days, Venetoclax orally once daily (100mg d1, 200mg d2, 400mg d3-28) and Chidamide 10mg orally daily for 12 days. Patients received 2 cycles of VACh treatments, the bone marrow aspirate will be done on the 21-28th day in the each cycle. If the bone marrow assessment is PR/NR at the end of the cycle 2, the patients need to withdraw from the trial. If the bone marrow assessment is CR/CRi/MLFS, the patients will start post-remission therapy. For post-remission therapy, if the patients ineligible for intensive chemotherapy or declines, continue with the same regimen until progression or recurrence of the disease, and the patients need to withdraw from the trial. If the patients fit for intensive chemotherapy, patients will receive consolidation chemotherapy with other regimens or transplantation, and the patients need to withdraw from the trial if progression or recurrence of the disease. |
| VACl Alternating With VACh group | Experimental | Drug: VACl Alternating With VAChPatients received 1 cycle of VACl and 1 cycle of VACh treatment, the bone marrow aspirate will be done on the 21-28th day in the each cycle. If the bone marrow assessment is PR/NR at the end of the cycle 2, the patients need to withdraw from the trial. If the bone marrow assessment is CR/CRi/MLFS, the patients will start post-remission therapy. For post-remission therapy, if the patients ineligible for intensive chemotherapy or declines, continue with the VACl alternating with VACh until progression or recurrence of the disease, and the patients need to withdraw from the trial. If the patients fit for intensive chemotherapy, patients will receive consolidation chemotherapy with other regimens or transplantation, and the patients need to withdraw from the trial if progression or recurrence of the disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- A subject will be eligible for study participation if he/she meets the following criteria within 21 days prior to randomization.
- Subject must have confirmation of previously untreated AML by World Health Organization (WHO) criteria, and be ineligible for treatment with a standard cytarabine and anthracycline induction regimen due age or comorbidities. Prior therapy with hydroxyurea or a total dose of cytarabine no more than 0.5g (for emergency use for stabilization) is allowed.
- Subject must be≥18 years of age with at least one of the following conditions:
- A)≥60 years of age; B) Patients aged < 60 years who are unsuitable for standard induction therapy（Any other comorbidity that the physician judges to be incompatible with conventional intensive chemotherapy); C) The patient refused the conventional intensive chemotherapy.
- Adequate organ function as defined below:
Key exclusion criteria (14 listed)
- Subject has a history of other malignancies prior to study entry, with the exception of:
- Subject has acute promyelocytic leukemia, subject has history of myeloproliferative neoplasm [MPN] including myelofibrosis, essential thrombocythemia, polycythemia vera, CML with or without BCR-ABL1 translocation, BCR/ABL positive AML.
- Patient has known active central nervous syster (CNS) involvement with AML.
- Subject has a white blood cell count> 25×10^9/L. (Hydroxyurea is permitted to meet this criterion.)
- Prior therapy with venetoclax, Cladribine, hypomethylating agents (HMAs), Chidamide or Chimeric Antigen Receptor T cell therapy, experimental therapies for MDS or AML.
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 |
|---|---|---|
| VAClAlso: Venetoclax+Azacitidine+CladribineAzacitidine:75mg/m2 Subcutaneous daily for 7 days Venetoclax: orally once daily (100 mg d1, 200mg d2, 400mg d3-28) Cladribine: 5mg/m2 IV over approximately 1 to 2 hours, daily on days 1-3. | Drug | VACl group |
| VAChAlso: Venetoclax+Azacitidine+ChidamideAzacitidine: 75mg/m2 Subcutaneous daily for 7 days Venetoclax: orally once daily (100mg d1, 200mg d2, 400mg d3-28) Chidamide: 10mg orally daily for 12 days | Drug | VACh group |
| VACl Alternating With VAChAlso: Venetoclax+Azacitidine+Cladribine alternating with Venetoclax+Azacitidine+ChidamideVACl: Azacitidine:75mg/m2 Subcutaneous daily for 7 days Venetoclax: orally once daily (100 mg d1, 200mg d2, 400mg d3-28) Cladribine: 5mg/m2 IV over approximately 1 to 2 hours, daily on days 1-3. VACh: Azacitidine: 75mg/m2 Subcutaneous daily for 7 days Venetoclax: orally once daily (100mg d1, 200mg d2, 400mg d3-28) Chidamide: 10mg orally daily for 12 days | Drug | VACl Alternating With VACh group |
| VAAlso: Venetoclax+AzacitidineAzacitidine: 75mg/m2 Subcutaneous (SC) daily for 7 days Venetoclax: orally once daily (100mg d1, 200mg d2, 400mg d3-28). | Drug | VA group |
Primary outcome
Event-free survival (EFS)
Time frame: 1 year
It is defined as the number of days from the date of randomization to the date of earliest evidence of relapse, subsequent treatment other than stem cell transplant while in composite complete remission (CR+CRi), or death. If the specified event (relapse, start of subsequent treatment, or death) does not occur, subjects will be censored at the date of last disease assessment.
Cumulative incidence of relapse (CIR)
Time frame: 1 year
Time from CR to disease recurrence or progression
4 secondary outcomes
Composite complete response (CRc)
Time frame: At the end of Cycle 1 (each cycle is 21-28 days)
Overall Survival (OS)
Time frame: 1 year
Adverse reactions in hematology
Time frame: At the end of Cycle 1 (each cycle is 21-28 days)
Nonhematological adverse reactions
Time frame: At the end of Cycle 1 (each cycle is 21-28 days)
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 19 Nov 2025.
- Individual participant dataSharing planned: No
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Enrolling by invitationPhase 1
A Rollover Study for Continued Study Treatment and Ongoing Safety Monitoring
Leukemia, Myeloid, Acute, Leukemia, Lymphocytic, Chronic, B-Cell
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.
Sheng-Li Xue, M.D. principal investigator
The First Affliated Hospital of Soochow University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VACl, VACh and VACl Alternating With VACh in people with Acute Myeloid Leukemia, Adult and Newly Diagnosed, run by The First Affiliated Hospital of Soochow University at 1 site 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 12 inclusion and 14 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 19 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 1 site 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 Sheng-Li Xue, M.D. (008651267781139, slxue@suda.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event-free survival (EFS) (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Nov 2025.