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ACTIVE NOT RECRUITING
NCT07187505
NA

Venetoclax Combined With ATRA and ATO in Hyperleukocytic Acute Promyelocytic Leukemia

Sponsor: Anhui Medical University

View on ClinicalTrials.gov

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.

Official title: Venetoclax Plus All-Trans Retinoic Acid and Arsenic Trioxide in Newly Diagnosed Acute Promyelocytic Leukemia With Hyperleukocytosis: A Prospective Single-Arm Study

Key Details

Gender

All

Age Range

14 Years - Any

Study Type

INTERVENTIONAL

Enrollment

28

Start Date

2025-07-01

Completion Date

2027-07-01

Last Updated

2025-09-23

Healthy Volunteers

No

Interventions

DRUG

Venetoclax

Venetoclax is a selective BCL-2 inhibitor administered orally once daily. The dose will be adjusted according to the study protocol and patient tolerance.

DRUG

All-trans retinoic acid

All-Trans Retinoic Acid (ATRA) is administered orally, twice daily, as part of standard induction and consolidation therapy for acute promyelocytic leukemia.

DRUG

Arsenic Trioxide (ATO)

Arsenic Trioxide (ATO) is administered intravenously once daily, in combination with ATRA and venetoclax, during induction and consolidation therapy.

Locations (1)

Department of Hematology, The First Affiliated Hospital of Anhui Medical University, 218 Jixi Road

Hefei, Anhui, China