Venetoclax Combined With ATRA and ATO in Hyperleukocytic Acute Promyelocytic Leukemia (NCT07187505) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Venetoclax Combined With ATRA and ATO in Hyperleukocytic Acute Promyelocytic Leukemia
China28 participantsStarted 2025-07-01
Plain-language 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 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.
Who can participate
Age range14 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.