A Single-center, Prospective, Exploratory Clinical Study
ConditionAcute Lymphoblastic Leukemia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLanZhou University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Newly diagnosed acute lymphoblastic leukemia (ALL) confirmed by bone marrow morphology, immunophenotyping, cytogenetics, and molecular biology according to the WHO 2022 classification criteria.
Age ≥ 18 years, male or female.
Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0-2.
Life expectancy ≥ 3 months.
Disqualifiers
Diagnosis of mixed-phenotype acute leukemia (MPAL) or Burkitt lymphoma/leukemia according to the WHO 2008 classification criteria for tumors of hematopoietic and lymphoid tissues.
Concurrent severe and/or uncontrolled underlying diseases, including but not limited to: other malignancies requiring concurrent treatment, acute or chronic hepatitis, severe pancreatic or renal disease, or other life-threatening underlying conditions; presence of severe active infections (e.g., sepsis, active tuberculosis, uncontrolled pneumonia, etc.).
Pregnant or lactating women.
Positive test for anti-HIV antibodies.
Trial design
Design model
Single group
Treatments tested in this trial
Lisaftoclax
DrugLisaftoclax(C1D1: 200mg; D2:400mg; D3-D14:600mg)
Treatment groups
30 Participants
are divided into 3 treatment groupsGroup A: Philadelphia Chromosome Positive（Ph⁺ ALL）Experimental treatment 1 intervention
Group B: Philadelphia Chromosome Negative（Ph- ALL）Experimental treatment 1 intervention
Group C: T-Cell Acute Lymphoblastic Leukemia（T-ALL）Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Complete Remission (CR) Rate After Induction Therapy
Time frame
At the end of induction therapy (Day 28-35)2
Complete Remission (CR) Rate After Induction Therapy
Time frame
At the end of induction therapy (Day 28)Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: