Combining venetoclax and azacitidine for newly diagnosed T-ALL patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2, open-label, single-arm, multi-center study aims to evaluate the efficacy and safety of a treatment regimen combining venetoclax and azacitidine in patients newly diagnosed with T-cell acute lymphoblastic leukemia (T-ALL). Participants aged 15 and older will receive the combined therapy as an induction regimen. The study will assess how well this combination works in treating T-ALL and monitor any potential side effects. The research is being conducted at multiple sites, including The First Affiliated Hospital of Soochow University.

Why it matters

Who can join: the full rules

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.

Where it's running

• The First Affliated Hospital of Soochow University
  Suzhou, Jiangsu, China Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Calaspargase pegol, decitabine, and venetoclax combination for relapsed/refractory T-cell ALL and T-LLy in children and young adults

  This treatment tries to see if giving calaspargase pegol and decitabine together with venetoclax can control relapsed or refractory T-ALL and T-LLy in children and young adults.

  Recruiting Phase 2 M.D. Anderson Cancer Center · Houston, Texas · NCT06561074

• WU-CART-007 anti-CD7 CAR-T for relapsed or MRD-positive T-cell ALL and lymphoblastic lymphoma

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.