T-cell Acute Lymphoblastic LeukemiaPhase 2NCT05376111
Study of Venetoclax Combined With Azacitidine Regimen in Newly Diagnosed T-ALL Patients
A Phase 2 study testing Venetoclax, Azacitidine in people with T-cell Acute Lymphoblastic Leukemia and Recruiting, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of venetoclax combined with azacitidine regimen for newly diagnosed T-ALL patients. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- T-cell Acute Lymphoblastic Leukemia, Recruiting
- What is being tested?
- Venetoclax, Azacitidine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2022to 1 Dec 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.
- Patients diagnosed with T-ALL according to 2016 WHO criteria for precursor lymphoid neoplasms.
- ECOG performance status score less than 3.
- Patients without serious heart, lung, liver, or kidney dysfunction.
- 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.
- Patients with uncontrolled active infection
- Patients with 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.
Show all 11Show fewer
- Liver dysfunction (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 chemotherapy treatments related to the disease.
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, (0086)51267781139, slxue@suda.edu.cn
About this study
Official title: A Prospective, Multi-Center Study to Evaluate the Efficacy and Safety of Venetoclax Combined With Azacitidine Regimen in Newly Diagnosed T-cell Acute Lymphoblastic Leukemia Patients
The purpose of this study is to evaluate the efficacy and safety of venetoclax combined with azacitidine regimen for newly diagnosed T-ALL patients.
Read the detailed description
This is a phase 2, open Label, single arm, multi-center study for newly diagnosed T-cell acute lymphoblastic leukemia patients. The patients will receive vanetoclax combined with azacitidine as the induction regimen.
- Conditions
- T-cell Acute Lymphoblastic Leukemia, Recruiting
- Being tested
- Venetoclax, Azacitidine
- Keywords
- Venetoclax, Azacitidine, T-ALL, Newly diagnosed
- Medical subject headings
- Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venetoclax, AzacitidineDrug
Venetoclax orally once daily (100 mg d1, 200 mg d2, 400 mg d3-21); azacitidine 75 mg/m2 subcutaneously once daily on days 1-7.
| Study group | Role | What they receive |
|---|---|---|
| Venetclax combined with Azacitidine | Experimental | T-cell acute lymphoblastic leukemia patients reveive venetoclax combined with azacitidine regimen treatment. Receives: Drug: Venetoclax, Azacitidine |
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 (21 days) induction therapy by venetoclax combined azacitidine regimen.
Measured: At the end of Cycle 1 (each cycle is 21 days)
Secondary outcomes (3)
Overall survial (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: 2 years
Progression-Free Survival (PFS)
It is measured from the date of entry into this trial to the date of progression or death.
Measured: 2 years
Number of adverse events
Adverse events are evaluated with CTCAE V5.0.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start1 Apr 2022
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T-cell Acute Lymphoblastic LeukemiaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- 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, Northern Jiangsu People's Hospital, Affiliated Hospital of Nantong University, Suzhou Hospital of Traditional Chinese Medicine
- Responsible party
- Principal investigator, Sheng-Li Xue, MD, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05376111
- Sponsor's protocol ID
- SZTALL01
- Status last verified
- Mar 2026
- First submitted
- 11 May 2022
- Last updated
- 19 Mar 2026
- 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 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-Center Study to Evaluate the Efficacy and Safety of Venetoclax Combined With Azacitidine Regimen in Newly Diagnosed T-cell Acute Lymphoblastic Leukemia Patients
- ClinicalTrials.gov ID
- NCT05376111
- Acronym / sponsor ID
- SZTALL01
- Conditions
- T-cell Acute Lymphoblastic Leukemia, Recruiting
- Keywords
- Venetoclax, Azacitidine, T-ALL, Newly diagnosed
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Collaborators
- Jining Medical University, The Second People's Hospital of Huai'an, The First Affiliated Hospital of Bengbu Medical University, Northern Jiangsu People's Hospital, Affiliated Hospital of Nantong University, Suzhou Hospital of Traditional Chinese Medicine
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 17 May 2022 (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 purpose of this study is to evaluate the efficacy and safety of venetoclax combined with azacitidine regimen for newly diagnosed T-ALL patients.
Detailed description
This is a phase 2, open Label, single arm, multi-center study for newly diagnosed T-cell acute lymphoblastic leukemia patients. The patients will receive vanetoclax combined with azacitidine as the induction regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Venetclax combined with Azacitidine | Experimental | Drug: Venetoclax, AzacitidineT-cell acute lymphoblastic leukemia patients reveive venetoclax combined with azacitidine regimen treatment. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged ≥ 15.
- Patients diagnosed with T-ALL according to 2016 WHO criteria for precursor lymphoid neoplasms.
- ECOG performance status score less than 3.
- Patients without serious heart, lung, liver, or kidney dysfunction.
- Ability to understand and voluntarily provide informed consent.
Key exclusion criteria (11 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.
- Patients with uncontrolled active infection
- Patients with 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 |
|---|---|---|
| Venetoclax, AzacitidineVenetoclax orally once daily (100 mg d1, 200 mg d2, 400 mg d3-21); azacitidine 75 mg/m2 subcutaneously once daily on days 1-7. | Drug | Venetclax combined with Azacitidine |
Primary outcome
Overall Response Rate (ORR)
Time frame: At the end of Cycle 1 (each cycle is 21 days)
The overall response (complete remission, complete remission with incomplete blood count recovery) rate achieved after one or two courses (21 days) induction therapy by venetoclax combined azacitidine regimen.
3 secondary outcomes
Overall survial (OS)
Time frame: 2 years
Progression-Free Survival (PFS)
Time frame: 2 years
Number of adverse events
Time frame: 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 19 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for T-cell Acute Lymphoblastic Leukemia
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Recruiting
A Multicenter Study to Evaluate Next-Generation Sequencing (NGS) Testing and Monitoring of B-Cell Recovery to Guide Management Following Chimeric Antigen Receptor T-cell (CART) Induced Remission in Children and Young Adults With B Lineage Acute Lymph...
B-All, Acute Lymphoblastic Leukemia
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
Active, not recruitingPhase 2
Valemetostat Tosylate (DS-3201b), an Enhancer of Zeste Homolog (EZH) 1/2 Dual Inhibitor, for Relapsed/Refractory Peripheral T-Cell Lymphoma (VALENTINE-PTCL01)
Relapsed/Refractory Peripheral T-Cell Lymphoma, Adult T Cell Leukemia/Lymphoma
RecruitingPhase 1
A Phase I Dose Finding Study of MB-CART2219.1
Lymphoma, CLL
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, Azacitidine in people with T-cell Acute Lymphoblastic Leukemia and Recruiting, 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 5 inclusion and 11 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 Mar 2026. 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?
Each site lists its own contact: choose the nearest one under Trial locations. 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 21 days)). 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 Mar 2026.