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

Sponsor
The First Affiliated Hospital of Soochow University
Study ID
NCT07159620
Phase
PHASE2
Status
Recruiting
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Conditions

  • Adult T-cell Leukemia/Lymphoma

Eligibility Criteria

Sex
ALL
Age
14 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • VEN (Venetoclax) — DRUG
    Orally
  • Azacitidine (AZA) — DRUG
    Subcutaneous injection
  • Chidamide — DRUG
    Orally
  • vindesine — DRUG
    intravenous infusion
  • Dexamethasone — DRUG
    intravenous infusion or orally

Study Details

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) .

Key Dates

Start date
Sep 1, 2025
Status verified
Sep 2025
Primary completion
Sep 1, 2028
Completion
Sep 1, 2030

Study Design

Enrollment
27 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Venetoclax Combined with Azacitidine, Chidamide, Vindesine, and Dexamethasone
    Induction Therapy Phase: VACVP induction:Venetoclax: 100mg, d1, 200mg, d2, 400mg, d3-d21, orally. Azacitidine,75mg/m²/day, d1-d7, subcutaneously. Chidamide,10mg, d1-d7, orally. Vindesine, 4mg, d1, intravenous infusion. Dexamethasone,9mg/m²/day, d1-d14; reduced by half on d15-d17; further reduced by half on d18-d21, intravenous infusion or orally. Consolidation therapy: 1. alternate use of HD-MTX-Ara C and VACVP 2. allogeneic hematopoietic stem cell transplantation (HSCT)

Primary Outcome Measure

Composite Complete Remission Rate（CRc） after induction therapy [ Time Frame: Time from the completion of induction and before consolidation therapy（up to 42 days） ]

Central Contacts

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