Status:
COMPLETED
Study of Azacitidine，Venetoclax，and Flumatinib in Newly Diagnosed Ph-positive Acute Leukemia and CML-AP/BP Patients
Lead Sponsor:
The First Affiliated Hospital of Soochow University
Conditions:
Philadelphia Chromosome
Acute Myeloid Leukemia
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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 bl...
Detailed Description
This is a phase Ⅱ, open-label, single-arm, single-center study in newly diagnosed Ph-positive acute leukemia and CML-AP/BP patients. The patients will receive azacitidine, venetoclax, and flumatinib r...
Eligibility Criteria
Inclusion
- Newly diagnosed Ph-positive ALL/AML/MPAL and CML-AP/BP without the history of chemotherapy or target therapy.
- Age 18-65.
- Eastern Cooperative Oncology Group (ECOG) score: 0-3.
- Total serum bilirubin ≤ 2 x upper limit of normal (ULN), alanine aminotransferase (ALT) ≤ 1.5 x ULN, aspartate aminotransferase (AST) ≤ 1.5 x ULN.
- Creatinine clearance ≥ 30 mL/min.
- Serum lipase ≤ 1.5 x ULN, amylase =\< 1.5 x ULN.
- No consumption of grapefruit, grapefruit products, Seville oranges, or star fruit within 3 days prior to starting venetoclax.
- Provide informed consent.
Exclusion
- Patients with another malignant disease.
- Patients has participated in or participating in other clinical trials.
- Patients with uncontrolled active infection.
- Patients with left ventricular ejection fraction \< 0.5 by echocardiography or grade III/IV cardiovascular dysfunction according to the New York Heart Association Classification.
- Patients with HIV infection, active tuberculosis infection, or active hepatitis B or hepatitis C infection.
- Patients with uncontrolled active bleeding.
- Patients with history of previous chemotherapy or target therapy (except for oral hydroxyurea and/or leukopheresis for lowering white blood cell counts).
- Pregnant and lactating women; patients of childbearing potential should be willing to practice methods of contraception throughout the study period.
- Patients with other commodities that the investigators considered not suitable for the enrollment.
Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 13 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05433532
Start Date
May 1 2022
End Date
April 13 2024
Last Update
April 25 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006