Study of Azacitidine，Venetoclax，and Flumatinib in Newly Diagnosed Ph-positive Acute Leukemia and … (NCT05433532) | Clinical Trial Compass
CompletedPhase 2
Study of Azacitidine，Venetoclax，and Flumatinib in Newly Diagnosed Ph-positive Acute Leukemia and CML-AP/BP Patients
China20 participantsStarted 2022-05-01
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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 criteria
✕. 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.
What they're measuring
1
CMR
Timeframe: End of cycle 2 (each cycle is 28 days)
Trial details
NCT IDNCT05433532
SponsorThe First Affiliated Hospital of Soochow University
✕. 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.