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

Sponsor
The First Affiliated Hospital of Soochow University
Study ID
NCT06578546
Phase
PHASE2
Status
Unknown

Conditions

  • Ph-Positive Acute Lymphoblastic Leukemia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Feb 1, 2024
Status verified
Apr 2024
Primary completion
Feb 1, 2025
Completion
Feb 1, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Venetoclax, Azacitidine, and Orebatinib Regimen
    See Detailed Description.

Primary Outcome Measure

complete molecular remission（CMR） [ Time Frame: End of cycle 1 and 2 (each cycle is 28 days) ]

Central Contacts