NCT07159620 Venetoclax Combined With Azacitidine, Chidamide, Vindesine, and Dexamethasone in Newly Diagnosed ETP-ALL Like Patients
| NCT ID | NCT07159620 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | The First Affiliated Hospital of Soochow University |
| Condition | Adult T-cell Leukemia/Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 27 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2028-09-01 |
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 27 participants in total. It began in 2025-09-01 with a primary completion date of 2028-09-01.
⚠ 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
ETP-ALL like patients have poor outcomes and prognosis, and the optimal therapeutic approaches are poorly characterized. The goal of this clinical trial is to evaluate the efficacy and safety of the venetoclax combined with azacitidine, chidamide, vindesine, and dexamethasone regimen in newly diagnosed ETP-ALL like patinets (including ETP-ALL, near ETP-ALL and T-ALL with myeloid mutations) .
Eligibility Criteria
Inclusion Criteria: 1. Age: \>14 to 65 years (inclusive). 2. Diagnosis: Patients diagnosed with ETP-ALL like disease meeting the following flow cytometry immunophenotypic criteria: ETP-ALL: CD7+, CD1a-, CD8-, CD5 positivity rate ≤75%, and positive for at least one myeloid/stem cell antigen marker (including but not limited to CD34, CD117, HLA-DR, CD13, CD33, CD11b, or CD65); MPO negative. Near-ETP-ALL: CD7+, CD1a-, CD8-, CD5 positivity rate \>75%, AND positive for at least one myeloid/stem cell antigen marker (including but not limited to CD34, CD117, HLA-DR, CD13, CD33, CD11b, or CD65); MPO negative. T-ALL with myeloid mutations: FLT3, DNMT3A, STAG2, IDH1/IDH2, RUNX1, EZH2, WT1, ASXL1/ASXL2, SF3B1, TET2, BCOR, BCORL1. 3. Newly diagnosed patients who have not received any prior induction therapy before enrollment (excluding hydroxyurea, dexamethasone, low-dose cytarabine, venetoclax with a cumulative dose \<0.5g, and leukapheresis). 4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2. 5. Expected survival \>6 months. 6. Demonstrated capacity to understand the study and willingness to provide informed consent. Exclusion Criteria: 1. Pregnancy, breastfeeding, or unwillingness to use contraception in women of childbearing potential 2. Presence of uncontrolled active infection (including bacterial, fungal, or viral infections); concurrent active HBV, HCV, or HIV infection. 3. Severe Organ Dysfunction: Cardiac Insufficiency: Left ventricular ejection fraction (LVEF) ≤40%, OR history of congestive heart failure, unstable coronary artery disease, or severe arrhythmia. Respiratory Failure: Partial pressure of arterial oxygen (PaO₂) ≤60 mmHg. Hepatic Impairment: Total bilirubin ≥2 times the upper limit of normal (ULN), OR alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3 times ULN. Renal Impairment: Serum creatinine ≥2 mg/dL, OR creatinine clearance ≤30 mL/min/1.73m². Hypersensitivity: History of hypersensitivity to any of the study drugs or compounds of similar chemical structure. 4. Presence of central nervous system (CNS) leukemia. 5. Any other condition deemed by the investigator to make the subject unsuitable for participation in this trial.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07159620 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, up to 65 Years, studying Adult T-cell Leukemia/Lymphoma. 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 NCT07159620 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 NCT07159620 currently recruiting?
Yes, NCT07159620 is actively recruiting participants. Contact the research team at xuyang1020@126.com for enrollment information.
Where is the NCT07159620 trial being conducted?
This trial is being conducted at Suzhou, China.
Who is sponsoring the NCT07159620 clinical trial?
NCT07159620 is sponsored by The First Affiliated Hospital of Soochow University. The trial plans to enroll 27 participants.
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