Clinical trial · Interventional
Study of Venetoclax Combined With Azacitidine Regimen in Newly Diagnosed T-ALL Patients
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
NCT05376111CI-TRIAL-00105963recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the efficacy and safety of venetoclax combined with azacitidine regimen for newly diagnosed T-ALL patients.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recruiting | — | UNRESOLVED | — |
| T-cell Acute Lymphoblastic Leukemia | T Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Venetoclax, Azacitidine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Venetclax combined with Azacitidine
- description
- T-cell acute lymphoblastic leukemia patients reveive venetoclax combined with azacitidine regimen treatment.
- interventionNames
- Drug: Venetoclax, Azacitidine
Primary outcomes (1)
- measure
- Overall Response Rate (ORR)
- timeFrame
- At the end of Cycle 1 (each cycle is 21 days)
- description
- 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.
Secondary outcomes (3)
- measure
- Overall survial (OS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients aged ≥ 15. 2. Patients diagnosed with T-ALL according to 2016 WHO criteria for precursor lymphoid neoplasms. 3. ECOG performance status score less than 3. 4. Patients without serious heart, lung, liver, or kidney dysfunction. 5. Ability to understand and voluntarily provide informed consent. Exclusion Criteria: 1. Patients who are allergic to the study drug or drugs with similar chemical structures. 2. Pregnant or lactating women, and women of childbearing age who do not want to practice effective methods of contraception. 3. Patients with uncontrolled active infection 4. Patients with active bleeding. 5. Patients with new thrombosis, embolism, cerebral hemorrhage, or other diseases or a medical history within one year before enrollment. 6. 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. 7. 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). 8. 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. 9. Surgery on the main organs within the past six weeks. 10. Drug abuse or long-term alcohol abuse that would affect the evaluation results. 11. Patients who have received chemotherapy treatments related to the disease.
References
Publications (0)
Data not yet available
No reference posted for this study.