NCT06578546

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: The First Affiliated Hospital of Soochow University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 orebatinib regimen in the induction treatment. The patients who respond to induction treatment will undergo consolidation treatment, and an optional allogeneic hematopoietic stem cell transplantation and post-transplantation maintenance treatment with induction therapy according to patient's wishes.

Conditions

• Ph-Positive Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
DRUG	Venetoclax	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.
DRUG	Azacitidine	75mg/m2 qd, d1-d7, subcutaneous injection, every 28 days for a treatment cycle.
DRUG	Orebatinib	20mg qod, d4-d21, oral, every 28 days for a treatment cycle.

Timeline

• Start date: 2024-02-01
• Primary completion: 2025-02-01
• Completion: 2026-02-01
• First posted: 2024-08-29
• Last updated: 2024-08-29

Locations

1 site across 1 country: China