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RecruitingPhase 2NCT06578546

Chemotherapy-free Regimen of Venetoclax, Azacitidine Plus Orebatinib (VAO Regimen) for Newly Diagnosed ph+ALL

A Single-arm, Open Label, Multicenter Clinical Study to Evaluate the Safety and Efficacy of VAO Regimen in Patients With Newly Diagnosed Ph-positive Acute Lymphoblastic Leukemia

Sponsor

The First Affiliated Hospital of Soochow University

Enrollment

30 participants

Start Date

Feb 1, 2024

Study Type

INTERVENTIONAL

Conditions

Ph-Positive Acute Lymphoblastic Leukemia

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria7

  • 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 Criteria9

  • 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.

Interventions

DRUGVenetoclax

100mg d1, 200mg d2, 400mg d2-21, oral (Adjusted according to the plasma concentration of venetoclax on day 4)，every 28 days for a treatment cycle.

DRUGAzacitidine

75mg/m2 qd, d1-d7, subcutaneous injection, every 28 days for a treatment cycle.

DRUGOrebatinib

20mg qod, d4-d21, oral, every 28 days for a treatment cycle.

Locations(1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

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NCT06578546