Acute Leukemia of Ambiguous LineagePhase 2NCT05901974
Venetoclax Combined With Azactidine in the Treatment of ALAL
A Phase 2 study testing Venetoclax and azactidine in people with Acute Leukemia of Ambiguous Lineage, run by Sheng-Li Xue, MD at 1 site in China.
Trial summary
The prognosis of acute leukaemias of ambiguous lineage is poor. The effect of chemotherapy regimen and hematopoietic stem cell transplantation are still unclear. Therefore, we will explore new therapy to improve the remission rate of acute leukaemias of ambiguous lineage. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Acute Leukemia of Ambiguous Lineage
- What is being tested?
- Venetoclax and azactidine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2023to 1 Mar 2026
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients aged ≥ 15 years.
- Patients diagnosed with ALAL according to 5th edition of WHO Acute Leukaemias of Ambiguous Lineage diagnosis standard.
- New diagnosed patients.
- ECOG performance status score less than 3.
- Expected survival time ≥3 months.
- Patients without serious heart, lung, liver, or kidney disease.
- Ability to understand and voluntarily provide informed consent.
Who cannot join
- Patients who are allergic to the study drug or drugs with similar chemical structures.
- Pregnant or lactating women, and women of childbearing age who do not want to practice effective methods of contraception.
- Active infection.
- Active bleeding.
- Patients with new thrombosis, embolism, cerebral hemorrhage, or other diseases or a medical history within one year before enrollment.
- Patients with mental disorders or other conditions whereby informed consent cannot be obtained and where the requirements of the study treatment and procedures cannot be met.
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- Liver function abnormalities (total bilirubin > 1.5 times the upper limit of the normal range, ALT/AST > 2.5 times the upper limit of the normal range or patients with liver involvement whose ALT/AST > 1.5 times the upper limit of the normal range), or renal anomalies (serum creatinine > 1.5 times the upper limit of the normal value).
- Patients with a history of clinically significant QTc interval prolongation (male > 450 ms; female > 470 ms), ventricular heart tachycardia and atrial fibrillation, II-degree heart block, myocardial infarction attack within one year before enrollment, and congestive heart failure, and patients with coronary heart disease who have clinical symptoms and requiring drug treatment.
- Surgery on the main organs within the past six weeks.
- Drug abuse or long-term alcohol abuse that would affect the evaluation results.
- Patients who have received organ transplants (excepting bone marrow transplantation).
- Patients not suitable for the study according to the investigator's assessment.
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
Sheng-Li Xue
About this study
Official title: A Multicenter Prospective Clinical Study of Venetoclax Combined With Azactidine in the Treatment of Acute Leukaemias of Ambiguous Lineage
The prognosis of acute leukaemias of ambiguous lineage is poor. The effect of chemotherapy regimen and hematopoietic stem cell transplantation are still unclear. Therefore, we will explore new therapy to improve the remission rate of acute leukaemias of ambiguous lineage. Venetoclax can significantly improve the remission rate and prolong PFS and OS. At present, venetoclax combined with azacitidine or decitabine has become the preferred treatment regimen for elderly AML patients. It also shows a high response rate in relapsed/refractory AML or MDS patients. There are few clinical studies on the treatment of ALAL. The purpose of this study is to explore the efficacy and safety of venetoclax combined with azacitidine in the treatment of newly diagnosed ALAL patients.
- Conditions
- Acute Leukemia of Ambiguous Lineage
- Being tested
- Venetoclax, azactidine
- Medical subject headings
- Leukemia, Biphenotypic, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VenetoclaxDrug
Venetoclax orally once daily (100 mg d1, 200 mg d2, 400 mg d3-28);
azactidineDrug
azacitidine 75 mg/m2 subcutaneously once daily on days 1-7
| Study group | Role | What they receive |
|---|---|---|
| Venetoclax Combined With azactidine in the Treatment of Acute Leukaemias of Ambiguous Lineage | Experimental | Venetoclax combined with azacitidine regimen. Venetoclax orally once daily (100 mg d1, 200 mg d2, 400 mg d3-28); azacitidine 75 mg/m2 subcutaneously once daily on days 1-7 . Receives: Drug: Venetoclax; Drug: azactidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
The overall response (complete remission, complete remission with incomplete blood count recovery) rate achieved after one or two courses (28 days) induction therapy by venetoclax combined azacitidine regimen.
Measured: At the end of Cycle 1 (each cycle is 28 days)
Complete Remission Rate (CRR)
The complete remission rate achieved after one or two courses (28 days) induction therapy by venetoclax combined azacitidine regimen.
Measured: At the end of Cycle 1 (each cycle is 28 days)
Secondary outcomes (4)
Overall survival (OS)
It is measured from the date of entry into this trial to the date of death from any cause; patients not known to have died at last follow-up are censored on the date they were last known to be alive.
Measured: 1 year
Progression-Free Survival (PFS)
It is measured from the date of entry into this trial to the date of progression or death.
Measured: 1 year
Adverse events in hematological system
Record of adverse events in hematological system during and after designed venetoclax combined azacitidine regimen induction.
Measured: 1 year
Adverse events in other organs or systems
Record of adverse events in other organs or systems during and after designed venetoclax combined azacitidine regimen induction.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2023
- Study start1 Jul 2023
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Leukemia of Ambiguous LineageStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheng-Li Xue, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Jining Medical University, The Second People's Hospital of Huai'an, The First Affiliated Hospital of Bengbu Medical University, Affiliated Hospital of Nantong University, Suzhou Hospital of Traditional Chinese Medicine, Northern Jiangsu People's Hospital, First Affiliated Hospital of Pingdingshan University, Second Affiliated Hospital of Wannan Medical College, Canglang Hospital of Suzhou
- Responsible party
- Sponsor-investigator, Sheng-Li Xue, MD, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05901974
- Sponsor's protocol ID
- SZALAL01
- Status last verified
- Dec 2025
- First submitted
- 4 Jun 2023
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- 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 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Prospective Clinical Study of Venetoclax Combined With Azactidine in the Treatment of Acute Leukaemias of Ambiguous Lineage
- ClinicalTrials.gov ID
- NCT05901974
- Acronym / sponsor ID
- SZALAL01
- Conditions
- Acute Leukemia of Ambiguous Lineage
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- Sheng-Li Xue, MDUniversity, hospital or other
- Collaborators
- Jining Medical University, The Second People's Hospital of Huai'an, The First Affiliated Hospital of Bengbu Medical University, Affiliated Hospital of Nantong University, Suzhou Hospital of Traditional Chinese Medicine, Northern Jiangsu People's Hospital, First Affiliated Hospital of Pingdingshan University, Second Affiliated Hospital of Wannan Medical College, Canglang Hospital of Suzhou
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 13 Jun 2023 (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.
The prognosis of acute leukaemias of ambiguous lineage is poor. The effect of chemotherapy regimen and hematopoietic stem cell transplantation are still unclear. Therefore, we will explore new therapy to improve the remission rate of acute leukaemias of ambiguous lineage. Venetoclax can significantly improve the remission rate and prolong PFS and OS. At present, venetoclax combined with azacitidine or decitabine has become the preferred treatment regimen for elderly AML patients. It also shows a high response rate in relapsed/refractory AML or MDS patients. There are few clinical studies on the treatment of ALAL. The purpose of this study is to explore the efficacy and safety of venetoclax combined with azacitidine in the treatment of newly diagnosed ALAL patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Venetoclax Combined With azactidine in the Treatment of Acute Leukaemias of Ambiguous Lineage | Experimental | Drug: Venetoclax, Drug: azactidineVenetoclax combined with azacitidine regimen. Venetoclax orally once daily (100 mg d1, 200 mg d2, 400 mg d3-28); azacitidine 75 mg/m2 subcutaneously once daily on days 1-7 . |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Patients aged ≥ 15 years.
- Patients diagnosed with ALAL according to 5th edition of WHO Acute Leukaemias of Ambiguous Lineage diagnosis standard.
- New diagnosed patients.
- ECOG performance status score less than 3.
- Expected survival time ≥3 months.
Key exclusion criteria (12 listed)
- Patients who are allergic to the study drug or drugs with similar chemical structures.
- Pregnant or lactating women, and women of childbearing age who do not want to practice effective methods of contraception.
- Active infection.
- Active bleeding.
- Patients with new thrombosis, embolism, cerebral hemorrhage, or other diseases or a medical history within one year before enrollment.
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 |
|---|---|---|
| VenetoclaxVenetoclax orally once daily (100 mg d1, 200 mg d2, 400 mg d3-28); | Drug | Venetoclax Combined With azactidine in the Treatment of Acute Leukaemias of Ambiguous Lineage |
| azactidineazacitidine 75 mg/m2 subcutaneously once daily on days 1-7 | Drug | Venetoclax Combined With azactidine in the Treatment of Acute Leukaemias of Ambiguous Lineage |
Primary outcome
Overall Response Rate (ORR)
Time frame: At the end of Cycle 1 (each cycle is 28 days)
The overall response (complete remission, complete remission with incomplete blood count recovery) rate achieved after one or two courses (28 days) induction therapy by venetoclax combined azacitidine regimen.
Complete Remission Rate (CRR)
Time frame: At the end of Cycle 1 (each cycle is 28 days)
The complete remission rate achieved after one or two courses (28 days) induction therapy by venetoclax combined azacitidine regimen.
4 secondary outcomes
Overall survival (OS)
Time frame: 1 year
Progression-Free Survival (PFS)
Time frame: 1 year
Adverse events in hematological system
Time frame: 1 year
Adverse events in other organs or systems
Time frame: 1 year
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 16 Dec 2025.
- 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.
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 Venetoclax and azactidine in people with Acute Leukemia of Ambiguous Lineage, run by Sheng-Li Xue, MD 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 7 inclusion and 12 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 16 Dec 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, MD (0086-0512-67781139, slxue@suda.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR) (time frame: At the end of Cycle 1 (each cycle is 28 days)). 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 16 Dec 2025.