Acute Lymphoblastic LeukemiaNCT07795099
A Single-center, Prospective, Exploratory Clinical Study
A study testing Lisaftoclax in people with Acute Lymphoblastic Leukemia, run by LanZhou University.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- What is being tested?
- Lisaftoclax
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Males and females of childbearing potential who agree to use effective contraceptive measures.
- Adequate organ function as defined by the following laboratory parameters:
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- Total bilirubin ≤ 1.5 × upper limit of normal (ULN); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 × ULN; Serum creatinine < 1.5 × ULN; Serum amylase ≤ 1.5 × ULN; Creatine kinase-MB (CK-MB) ≤ 2 × ULN.
- Cardiac ejection fraction > 45% as determined by multigated acquisition (MUGA) scan.
- Voluntary participation in this clinical trial, with an understanding of the study procedures and the ability to provide written informed consent.
Who cannot join
- 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.
- Psychiatric disorders that may interfere with the patient's ability to complete the study treatment or provide informed consent.
- Any condition deemed by the investigator to make the patient unsuitable for enrollment.
- Inability to swallow capsules or tablets, or presence of gastrointestinal disorders significantly affecting gastrointestinal function and/or inhibiting small intestinal absorption (including malabsorption syndrome, small bowel resection, or poorly controlled inflammatory bowel disease).
- Known hypersensitivity to the study drug or any of its excipients.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Single-Center, Prospective, Exploratory Clinical Study of the Lishatoclax Combination Regimen in Adult Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
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.
- Conditions
- Acute Lymphoblastic Leukemia
- Being tested
- Lisaftoclax
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LisaftoclaxDrug
Lisaftoclax(C1D1: 200mg; D2:400mg; D3-D14:600mg)
| Study group | Role | What they receive |
|---|---|---|
| Philadelphia Chromosome Positive（Ph⁺ ALL） | Experimental | Hyper-CVAD+Lisaftoclax Receives: Drug: Lisaftoclax |
| Philadelphia Chromosome Negative（Ph- ALL） | Experimental | Hyper-CVAD+Lisaftoclax Receives: Drug: Lisaftoclax |
| T-Cell Acute Lymphoblastic Leukemia（T-ALL） | Experimental | Hyper-CVAD+Lisaftoclax Receives: Drug: Lisaftoclax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Remission (CR) Rate After Induction Therapy
Measured: At the end of induction therapy (Day 28-35)
Complete Remission (CR) Rate After Induction Therapy
Measured: At the end of induction therapy (Day 28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study startAug 2026 (estimated)
- Primary completionAug 2029 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LanZhou University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Long Zhao, LanZhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07795099
- Sponsor's protocol ID
- LZF-2026-001
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Prospective, Exploratory Clinical Study of the Lishatoclax Combination Regimen in Adult Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT07795099
- Acronym / sponsor ID
- LZF-2026-001
- Conditions
- Acute Lymphoblastic Leukemia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- LanZhou UniversityUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Aug 2029 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 31 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Philadelphia Chromosome Positive（Ph⁺ ALL） | Experimental | Drug: LisaftoclaxHyper-CVAD+Lisaftoclax |
| Philadelphia Chromosome Negative（Ph- ALL） | Experimental | Drug: LisaftoclaxHyper-CVAD+Lisaftoclax |
| T-Cell Acute Lymphoblastic Leukemia（T-ALL） | Experimental | Drug: LisaftoclaxHyper-CVAD+Lisaftoclax |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
- Males and females of childbearing potential who agree to use effective contraceptive measures.
Key exclusion criteria (8 listed)
- 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.
- Psychiatric disorders that may interfere with the patient's ability to complete the study treatment or provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LisaftoclaxLisaftoclax(C1D1: 200mg; D2:400mg; D3-D14:600mg) | Drug | Philadelphia Chromosome Negative（Ph- ALL）, Philadelphia Chromosome Positive（Ph⁺ ALL）, T-Cell Acute Lymphoblastic Leukemia（T-ALL） |
Primary outcome
Complete Remission (CR) Rate After Induction Therapy
Time frame: At the end of induction therapy (Day 28-35)
Complete Remission (CR) Rate After Induction Therapy
Time frame: At the end of induction therapy (Day 28)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Lisaftoclax in people with Acute Lymphoblastic Leukemia, run by LanZhou University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact long zhao zhao (+86 18893912796, zhaodragon@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Remission (CR) Rate After Induction Therapy (time frame: At the end of induction therapy (Day 28-35)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.