A Single-center, Prospective, Exploratory Clinical Study

Sponsor
LanZhou University
Study ID
NCT07795099
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

  • Lisaftoclax — DRUG
    Lisaftoclax(C1D1: 200mg; D2:400mg; D3-D14:600mg)

Study Details

This study is designed as a prospective, single-arm, exploratory clinical trial based on lishatoclax, enrolling three independent cohorts of patients with Philadelphia chromosome-positive (Ph⁺) ALL, Philadelphia chromosome-negative (Ph-) ALL, and T-cell ALL (T-ALL). By investigating the combination of lishatoclax with established standard chemotherapy, targeted agents (e.g., tyrosine kinase inhibitors, TKIs), or immunotherapies, this study aims to further improve the remission rates across all ALL subtypes, and to develop a more effective and less toxic novel therapeutic strategy for ALL, thereby addressing the unmet clinical needs in current practice.

Key Dates

First listed
Aug 31, 2026
Start date
Aug 31, 2026
Status verified
Aug 2026
Primary completion
Aug 31, 2029
Completion
Aug 31, 2029

Study Design

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

Arms

  • Experimental: Philadelphia Chromosome Positive（Ph⁺ ALL）
    Hyper-CVAD+Lisaftoclax
  • Experimental: Philadelphia Chromosome Negative（Ph- ALL）
    Hyper-CVAD+Lisaftoclax
  • Experimental: T-Cell Acute Lymphoblastic Leukemia（T-ALL）
    Hyper-CVAD+Lisaftoclax

Primary Outcome Measure

Complete Remission (CR) Rate After Induction Therapy [ Time Frame: At the end of induction therapy (Day 28-35) ]

Central Contacts

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