RecruitingPhase 2

Venetoclax Combined With Azacitidine, Chidamide, Vindesine, and Dexamethasone in Newly Diagnosed ETP-ALL Like Patients

China27 participantsStarted 2025-09-01

Plain-language 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) .

Who can participate

Age range14 Years – 65 Years

SexALL

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Inclusion criteria

✓. Age: \>14 to 65 years (inclusive).
✓. Diagnosis: Patients diagnosed with ETP-ALL like disease meeting the following flow cytometry immunophenotypic criteria:
✓. 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).
✓. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
✓. Expected survival \>6 months.
✓. Demonstrated capacity to understand the study and willingness to provide informed consent.

Exclusion criteria

✕. Pregnancy, breastfeeding, or unwillingness to use contraception in women of childbearing potential
✕. Presence of uncontrolled active infection (including bacterial, fungal, or viral infections); concurrent active HBV, HCV, or HIV infection.
✕. Severe Organ Dysfunction:
✕. Presence of central nervous system (CNS) leukemia.
✕. Any other condition deemed by the investigator to make the subject unsuitable for participation in this trial.

What they're measuring

Composite Complete Remission Rate（CRc） after induction therapy

Timeframe: Time from the completion of induction and before consolidation therapy（up to 42 days）

Trial details

NCT IDNCT07159620

SponsorThe First Affiliated Hospital of Soochow University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-09-01

Contact for this trial

Yang Xu

86+051267781850 xuyang1020@126.com

View on ClinicalTrials.gov More Adult T-cell Leukemia/Lymphoma trials