ClinicalTrials.gg
Not yet recruitingNCT07795099Updated Aug 31, 2026

A Single-center, Prospective, Exploratory Clinical Study

An interventional study of Lisaftoclax in Acute Lymphoblastic Leukemia, sponsored by LanZhou University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-31.

Sponsored by LanZhou University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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). 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.

02

Conditions studied

  • Acute Lymphoblastic Leukemia
03

In context

Precursor Cell Lymphoblastic Leukemia-Lymphoma

2,584 studies on the registry are indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma; 473 are open to participants now.

This study's planned enrollment of 30 is below the median of 40 across 1,952 interventional studies indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma.

Browse Precursor Cell Lymphoblastic Leukemia-Lymphoma studies →

Lead sponsor

LanZhou University is the lead sponsor of 27 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Newly diagnosed acute lymphoblastic leukemia (ALL) confirmed by bone marrow morphology, immunophenotyping, cytogenetics, and molecular biology according to the WHO 2022 classification criteria.
  2. Age ≥ 18 years, male or female.
  3. performance status (ECOG-PS) of 0-2.
  4. ≥ 3 months.
  5. Males and females of who agree to use effective measures.
  6. Adequate organ function as defined by the following laboratory parameters:

    Total ≤ 1.5 × (ULN); (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.

  7. Cardiac > 45% as determined by multigated acquisition (MUGA) scan.
  8. Voluntary participation in this clinical trial, with an understanding of the study procedures and the ability to provide written .

Exclusion criteria

Exclusion Criteria:

  1. 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.
  2. Concurrent severe and/or uncontrolled underlying diseases, including but not limited to: other 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.).
  3. Pregnant or lactating women.
  4. Positive test for anti- antibodies.
  5. Psychiatric disorders that may interfere with the patient's ability to complete the study treatment or provide .
  6. Any condition deemed by the investigator to make the patient unsuitable for enrollment.
  7. 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).
  8. Known to the study drug or any of its .
Terms in these criteria, in plain language(13)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Philadelphia Chromosome Positive(Ph⁺ ALL)

    Hyper-CVAD+Lisaftoclax

    Drug: Lisaftoclax

  • Experimental
    Philadelphia Chromosome Negative(Ph- ALL)

    Hyper-CVAD+Lisaftoclax

    Drug: Lisaftoclax

  • Experimental
    T-Cell Acute Lymphoblastic Leukemia(T-ALL)

    Hyper-CVAD+Lisaftoclax

    Drug: Lisaftoclax

Interventions

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

06

What researchers measure

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)

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Aug 2026; primary completion for Aug 2029, 36 months later.

Of 207 non-industry interventional studies with no phase under Precursor Cell Lymphoblastic Leukemia-Lymphoma, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 66. This study's planned 36 months is close to that.

Counting every sponsor, half of 214 studies reached it within 32 months; a quarter within 12 and three quarters within 66.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 26, 2026
First posted
Aug 31, 2026
StartEst.
Aug 2026
Primary completionEst.
Aug 2029
CompletionEst.
Aug 2029
Last update
Aug 31, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 31, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07795099
Lead sponsor
LanZhou University
Responsible party
Long Zhao (Chief Physician, Department of Hematology, LanZhou University) — Principal investigator
First posted
Aug 31, 2026
Start date
Aug 2026 (estimated)
Primary completion
Aug 2029 (estimated)
Completion
Aug 2029 (estimated)
Last update
Aug 31, 2026

Study contacts

long zhao zhao
Contact
zhaodragon@126.com
+86 18893912796

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Studies of the drug tested here: Lisaftoclax

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