Acute T-Lymphocytic LeukemiaPhase 2NCT05149378
Venetoclax Based Regimen for R/R T-ALL
A Phase 2 study testing Venetoclax combined with azacitidine regimen in people with Acute T-Lymphocytic Leukemia, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
This study is to investigate the therapeutic efficacy and side effect of venetoclax based regimen for relapsed or refractroy T cell acute lymphoblastic leukemia. Read more about this study
- Who is it for?
- Ages 15 to 70 years
- Conditions the study is for
- Acute T-Lymphocytic Leukemia
- What is being tested?
- Venetoclax combined with azacitidine regimen
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2021to 31 Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients aged ≥ 15 and ≤ 70 years.
- Patients diagnosed with T-ALL/LBL according to 2017 WHO lymphoid malignant disease diagnosis standard.
- Patients with T-ALL/LBL must meet one of the following criteria, A or B.
- A: Refractory T-ALL/LBL disease was defined as follows: Failure to achieve CR at the end of induction.
- B: Relapsed T-ALL/LBL disease was defined as follows: Reappearance of blasts in the blood or bone marrow (>5%) or in any extramedullary site after a CR.
- ECOG performance status score less than 3.
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- 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.
China1 site
The First Affliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
About this study
Official title: Venetoclax Based Regimen for the Treatment of Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia
This study is to investigate the therapeutic efficacy and side effect of venetoclax based regimen for relapsed or refractroy T cell acute lymphoblastic leukemia.
- Conditions
- Acute T-Lymphocytic Leukemia
- Being tested
- Venetoclax combined with azacitidine regimen
- Keywords
- venetoclax, relapse, refractory
- Medical subject headings
- Precursor T-Cell Lymphoblastic Leukemia-Lymphoma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venetoclax combined with azacitidine regimenDrug
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 | Relapsed or refractroy acute lymphoblastic leukemia patients reveive venetclax combined with azacitidine regimen treatment. Receives: Drug: Venetoclax combined with azacitidine regimen |
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)
Complete Remission Rate (CRR)
The complete remission 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 (4)
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: 1 year
Relapse-Free Survival (RFS)
It is measured from the date of entry into this trial to the date of hematologic relapse or death from any cause.
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 month
Adverse events in other organs or systems
Record of adverse events in other organs or systmes during and after designed venetoclax combined azacitidine regimen induction.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start1 Nov 2021
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
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 T-Lymphocytic 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
- 25 participants (actual)
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, Affiliated Hospital of Nantong University, Suzhou Hospital of Traditional Chinese Medicine, The First Affiliated Hospital of Anhui Medical University, Southern Medical University, China, Nanyang Central Hospital, Canglang Hospital of Suzhou
- Responsible party
- Principal investigator, Sheng-Li Xue, MD, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05149378
- Sponsor's protocol ID
- SZRTALL01
- Status last verified
- May 2025
- First submitted
- 25 Nov 2021
- Last updated
- 14 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cao HY, Zhang H, Zhang Y, Hu XH, Yang L, Yang YL, Zhang YM, Wu B, Huang ZQ, Huang R, Wang RJ, Wan CL, Wu DP, Dai HP, Xue SL. Venetoclax plus azacitidine in relapsed or refractory T-cell acute lymphoblastic leukaemia: a multicentre, single-arm, phase 2 trial. Lancet Haematol. 2025 Dec;12(12):e946-e955. doi: 10.1016/S2352-3026(25)00284-4.
PubMed 41338863
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Venetoclax Based Regimen for the Treatment of Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT05149378
- Acronym / sponsor ID
- SZRTALL01
- Conditions
- Acute T-Lymphocytic Leukemia
- Keywords
- venetoclax, relapse, refractory
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- 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, Affiliated Hospital of Nantong University, Suzhou Hospital of Traditional Chinese Medicine, The First Affiliated Hospital of Anhui Medical University, Southern Medical University, China, Nanyang Central Hospital, Canglang Hospital of Suzhou
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 8 Dec 2021 (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 study is to investigate the therapeutic efficacy and side effect of venetoclax based regimen for relapsed or refractroy T cell acute lymphoblastic leukemia.
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 combined with azacitidine regimenRelapsed or refractroy acute lymphoblastic leukemia patients reveive venetclax combined with azacitidine regimen treatment. |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Patients aged ≥ 15 and ≤ 70 years.
- Patients diagnosed with T-ALL/LBL according to 2017 WHO lymphoid malignant disease diagnosis standard.
- Patients with T-ALL/LBL must meet one of the following criteria, A or B.
- A: Refractory T-ALL/LBL disease was defined as follows: Failure to achieve CR at the end of induction.
- B: Relapsed T-ALL/LBL disease was defined as follows: Reappearance of blasts in the blood or bone marrow (>5%) or in any extramedullary site after a CR.
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 |
|---|---|---|
| Venetoclax combined with azacitidine regimenVenetoclax 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.
Complete Remission Rate (CRR)
Time frame: At the end of Cycle 1 (each cycle is 21 days)
The complete remission rate achieved after one or two courses (21 days) induction therapy by venetoclax combined azacitidine regimen.
4 secondary outcomes
Overall survial (OS)
Time frame: 1 year
Relapse-Free Survival (RFS)
Time frame: 1 year
Adverse events in hematological system
Time frame: 1 month
Adverse events in other organs or systems
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Derived from this study: PubMed 41338863Cao HY, Zhang H, Zhang Y, Hu XH, Yang L, Yang YL, Zhang YM, Wu B, Huang ZQ, Huang R, Wang RJ, Wan CL, Wu DP, Dai HP, Xue SL. Venetoclax plus azacitidine in relapsed or refractory T-cell acute lymphoblastic leukaemia: a multicentre, single-arm, phase 2 trial. Lancet Haematol. 2025 Dec;12(12):e946-e955. doi: 10.1016/S2352-3026(25)00284-4.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 combined with azacitidine regimen in people with Acute T-Lymphocytic Leukemia, 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 9 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: finished, as of the sponsor's last update on 14 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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)). 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?
On the ClinicalTrials.gov record for NCT05149378, 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 14 May 2025.