Status:
RECRUITING
Chemotherapy-free Regimen of Venetoclax, Azacitidine Plus Orebatinib (VAO Regimen) for Newly Diagnosed ph+ALL
Lead Sponsor:
The First Affiliated Hospital of Soochow University
Conditions:
Ph-Positive Acute Lymphoblastic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of Venetoclax, Azacitidine Plus Orebatinib in newly diagnosed Philadelphia chromosome-positive Acute Lymphoblastic Leukemia.
Detailed Description
This is a phase Ⅱ, single-arm, open Label, multicenter clinical study in newly diagnosed Ph-positive acute lymphoblastic leukemia patients. The patients will receive venetoclax, azacitidine and orebat...
Eligibility Criteria
Inclusion
- Newly diagnosed Ph-positive ALL without the history of chemotherapy or target therapy.
- Age ≥18.
- 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.
- Provide informed consent.
Exclusion
- Patients with another malignant disease.
- 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 who has participated or participating in other clinical trials related to this disease.
- 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 :
February 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06578546
Start Date
February 1 2024
End Date
February 1 2026
Last Update
August 29 2024
Active Locations (1)
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1
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006