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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age14-65
SponsorThe First Affiliated Hospital of Soochow University

About this trial

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

Qualifiers

Age: >14 to 65 years (inclusive).

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.

Disqualifiers

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.

Presence of central nervous system (CNS) leukemia.

Any other condition deemed by the investigator to make the subject unsuitable for participation in this trial.

Trial design

Treatments tested in this trial

  • VEN (Venetoclax)
  • Azacitidine (AZA)
  • Chidamide
  • vindesine
  • Dexamethasone

Treatment groups

27 Participants
are divided into 1 treatment group