NCT05376111 Study of Venetoclax Combined With Azacitidine Regimen in Newly Diagnosed T-ALL Patients
| NCT ID | NCT05376111 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | The First Affiliated Hospital of Soochow University |
| Condition | T-cell Acute Lymphoblastic Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 28 participants |
| Start Date | 2022-04-01 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 28 participants in total. It began in 2022-04-01 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Frequently Asked Questions
Who can join the NCT05376111 clinical trial?
This trial is open to participants of all sexes, aged 15 Years or older, studying T-cell Acute Lymphoblastic Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05376111 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05376111 currently recruiting?
Yes, NCT05376111 is actively recruiting participants. Visit ClinicalTrials.gov or contact The First Affiliated Hospital of Soochow University to inquire about joining.
Where is the NCT05376111 trial being conducted?
This trial is being conducted at Suzhou, China.
Who is sponsoring the NCT05376111 clinical trial?
NCT05376111 is sponsored by The First Affiliated Hospital of Soochow University. The trial plans to enroll 28 participants.
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