Status:
ACTIVE_NOT_RECRUITING
Venetoclax Combined With ATRA and ATO in Hyperleukocytic Acute Promyelocytic Leukemia
Lead Sponsor:
Anhui Medical University
Collaborating Sponsors:
The First Affiliated Hospital of Anhui Medical University
Conditions:
Acute Promyelocytic Leukemia (APL)
Eligibility:
All Genders
14+ years
Phase:
NA
Brief Summary
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 leu...
Detailed Description
PRIMARY OBJECTIVE 1. To evaluate the efficacy of the venetoclax + ATRA + ATO regimen, as defined by complete remission (CR), complete remission with incomplete hematologic recovery (CRi), and morpholo...
Eligibility Criteria
Inclusion
- Patients diagnosed with acute promyelocytic leukemia (APL) according to bone marrow morphology and immunophenotyping, consistent with the WHO 2016 diagnostic criteria.
- Age ≥14 years, both male and female patients are eligible.
- Adequate organ function, defined as:
- 1 Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤3 × upper limit of normal (ULN);
- 2 Total serum bilirubin ≤1.5 × ULN;
- 3 Creatinine clearance ≥30 mL/min;
- 4 Serum cardiac enzymes \<2.0 × ULN.
- Signed informed consent obtained from the patient or a legally authorized representative.
- White blood cell (WBC) count \>10 × 10⁹/L at initial diagnosis, or WBC \>10 × 10⁹/L during treatment.
Exclusion
- Diagnosis of acute non-promyelocytic leukemia, myeloid sarcoma, or chronic myeloid leukemia in accelerated or blast phase.
- Known hypersensitivity to any drug included in the study regimen.
- Pregnant or breastfeeding women, and women of childbearing potential who are unwilling to use effective contraception during the study treatment period.
- Presence of organic heart disease, such as uncontrolled or symptomatic arrhythmia, congestive heart failure, or myocardial infarction within 6 months prior to screening that resulted in clinical symptoms or impaired cardiac function (NYHA class ≥III).
- Concurrent malignancies, except for:
- 1 Malignancies treated with curative intent (e.g., hematopoietic stem cell transplantation) and with no known active disease for ≥5 years before enrollment;
- 2 Adequately treated non-melanoma skin cancer or malignant lentigo without evidence of disease, even if diagnosed \<3 years before enrollment;
- 3 Adequately treated carcinoma in situ without evidence of disease, even if diagnosed \<3 years before enrollment.
- Patients with acquired immunodeficiency syndrome (AIDS) or syphilis, or those with active hepatitis B (detectable HBV DNA) or active hepatitis C infection.
- Any concurrent medical condition or disease that may interfere with study procedures or outcomes, or that may pose an unacceptable risk to the participant as determined by the investigator (e.g., active systemic infection).
- Inability to understand or comply with the study protocol.
- Participation in another clinical study within 1 month prior to enrollment.
Key Trial Info
Start Date :
July 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT07187505
Start Date
July 1 2025
End Date
July 1 2027
Last Update
September 23 2025
Active Locations (1)
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1
Department of Hematology, The First Affiliated Hospital of Anhui Medical University, 218 Jixi Road
Hefei, Anhui, China, 230022