Venetoclax Combined With ATRA and ATO in Hyperleukocytic Acute Promyelocytic Leukemia

Sponsor
Anhui Medical University
Study ID
NCT07187505
Status
Active Not Recruiting

Conditions

  • Acute Promyelocytic Leukemia (APL)

Eligibility Criteria

Sex
ALL
Age
14 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Venetoclax — DRUG
    Venetoclax is a selective BCL-2 inhibitor administered orally once daily. The dose will be adjusted according to the study protocol and patient tolerance.
  • All-trans retinoic acid — DRUG
    All-Trans Retinoic Acid (ATRA) is administered orally, twice daily, as part of standard induction and consolidation therapy for acute promyelocytic leukemia.
  • Arsenic Trioxide (ATO) — DRUG
    Arsenic Trioxide (ATO) is administered intravenously once daily, in combination with ATRA and venetoclax, during induction and consolidation therapy.

Study Details

This study aims to evaluate the safety and effectiveness of combining venetoclax with all-trans retinoic acid (ATRA) and arsenic trioxide (ATO) in patients with newly diagnosed acute promyelocytic leukemia (APL) who have very high white blood cell counts. APL is a rare type of blood cancer, and patients with high white blood cell levels often face serious complications. Current treatments with ATRA and ATO are effective, but the outcomes for patients with high white blood cells remain poor. This study will test whether adding venetoclax, a drug that helps leukemia cells die, can improve treatment results.

Key Dates

Start date
Jul 1, 2025
Status verified
Sep 2025
Primary completion
Jul 1, 2027
Completion
Jul 1, 2027

Study Design

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

Arms

  • Experimental: Experimental Arm: Venetoclax + ATRA + ATO
    Patients in this arm will receive a combination regimen consisting of venetoclax, all-trans retinoic acid (ATRA), and arsenic trioxide (ATO) as induction therapy, followed by consolidation according to protocol. The regimen is designed for newly diagnosed acute promyelocytic leukemia (APL) with hyperleukocytosis.

Primary Outcome Measure

Early Mortality (Day 0-30) [ Time Frame: 30 days ]

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