Study of Azacitidine，Venetoclax，and Flumatinib in Newly Diagnosed Ph-positive Acute Leukemia and CML-AP/BP Patients

• Status: Recruiting
• Trial end date: 2025-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of azacitidine，venetoclax，and flumatinib in newly diagnosed Philadelphia chromosome-positive acute leukemia and accelerated phase or blast phase chronic myeloid leukemia patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital of Soochow University
• Treatments: Azacitidine; HH-GV-678; Venetoclax

Criteria

Inclusion Criteria:

1. Newly diagnosed Ph-positive ALL/AML/MPAL and CML-AP/BP without the history of chemotherapy or target therapy.

2. Age 18-65.

3. Eastern Cooperative Oncology Group (ECOG) score: 0-3.

4. Total serum bilirubin ≤ 2 x upper limit of normal (ULN), alanine aminotransferase (ALT) ≤ 1.5 x ULN, aspartate aminotransferase (AST) ≤ 1.5 x ULN.

5. Creatinine clearance ≥ 30 mL/min.

6. Serum lipase ≤ 1.5 x ULN, amylase =< 1.5 x ULN.

7. No consumption of grapefruit, grapefruit products, Seville oranges, or star fruit within 3 days prior to starting venetoclax.

8. Provide informed consent.

Exclusion Criteria:

1. Patients with another malignant disease.

2. Patients has participated in or participating in other clinical trials.

3. Patients with uncontrolled active infection.

4. Patients with left ventricular ejection fraction < 0.5 by echocardiography or grade III/IV cardiovascular dysfunction according to the New York Heart Association Classification.

5. Patients with HIV infection, active tuberculosis infection, or active hepatitis B or hepatitis C infection.

6. Patients with uncontrolled active bleeding.

7. Patients with history of previous chemotherapy or target therapy (except for oral hydroxyurea and/or leukopheresis for lowering white blood cell counts).

8. Pregnant and lactating women; patients of childbearing potential should be willing to practice methods of contraception throughout the study period.

9. Patients with other commodities that the investigators considered not suitable for the enrollment.