Venetoclax Combined With Olverembatinib and Predinisone in Treating Ph+ B-ALL

Sponsor
First Affiliated Hospital of Zhejiang University
Study ID
NCT06754267
Phase
PHASE2
Status
Recruiting
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Conditions

  • Precursor B-Cell Acute Lymphoblastic Leukemia

Eligibility Criteria

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

Interventions

  • Venetoclax — DRUG
    BCL-2 inhibotor
  • Olverembatinib — DRUG
    Tyrosine kinase inhibitor
  • Predinisone — DRUG
    Glucocorticoids

Study Details

Precursor B cell acute lymphoblastic leukemia (B-ALL) is an aggressive type of leukemia, with high relapse rate and poor long term survival in adults. Philadelphia chromosome positive (Ph+) ALL is defined as ALL with translocation between chromosomes 9 and 22. And t(9;22)(q34;q11) is the most common chromosomal abnormality in ALL. Before the emergence of TKI, the prognosis of Ph+ ALL was extremely poor, and the long-term survival rate was only 10%-35%. Ph+ ALL accounts for about 30% of adult ALL. In this study, the investigators propose a treatment approach that combines Venetoclax with Olverembatinib and Predinisone in Ph+ B-ALL adults. The study aims to answer the safety and efficacy of this treatment regimen, and further improve the survival for those participants.

Key Dates

Start date
Dec 31, 2024
Status verified
Dec 2024
Primary completion
Dec 30, 2025
Completion
Dec 30, 2027

Study Design

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

Arms

  • Experimental: Treatment arm
    Induction Cycle 1: Olverembatinib for 4 weeks, oral; Venetoclax for 4 weeks, oral; Predinisone for 3 weeks, oral. Consolidation Cycle 2 and 3: Olverembatinib for 4 weeks, oral; Venetoclax for 2 weeks, oral; Predinisone for 2 weeks, oral.

Primary Outcome Measure

complete molecular response (CMR) after three cycles [ Time Frame: At the end of Cycle 3（each cycle is 28 days） ]

Central Contacts