Can a Chemo-Free pill combo outsmart leukemia at first diagnosis?
NCT ID NCT06319456
First seen Jul 28, 2026 · Last updated Jul 29, 2026 · Updated 1 time
Summary
This phase 3 trial is testing whether a combination of two targeted oral drugs—lisaftoclax and acalabrutinib—can work better than standard chemoimmunotherapy for people newly diagnosed with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). About 344 participants will be randomly assigned to receive either the two-drug combo or a standard chemo regimen. The main goal is to see if the combo helps people live longer without their cancer progressing.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a combination of two oral drugs: lisaftoclax (a BCL-2 inhibitor) and acalabrutinib (a BTK inhibitor)
- What this could lead to
- If successful, this drug combination could offer a more targeted, chemotherapy-free option for people newly diagnosed with CLL/SLL, potentially improving how long they live without their disease getting worse.
- What could go wrong
- This is an early confirmatory trial, so the combination may not prove more effective than current treatments. Side effects from the two drugs together are still being studied.
Why investors are watching
Ascentage Pharma is running a Phase 3 trial testing its drug lisaftoclax combined with acalabrutinib against standard immunochemotherapy in 344 newly diagnosed patients with chronic lymphocytic leukemia or small lymphocytic lymphoma. For a small company, this confirmatory study is a key test of whether its drug can improve outcomes in a common blood cancer. A clear result would validate the drug's value and shape the company's future.
If it works: A positive result could support regulatory approval and give Ascentage a stronger position in the blood cancer market. It might also lead to partnerships or licensing deals that bring in revenue.
If it fails: The trial could fail to show that the combination works better than existing treatment, which would hurt the drug's prospects. Delays or safety problems could also set the company back, and many Phase 3 trials do not succeed.
AI-written from the trial record. Speculative, and not investment advice.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 344 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2024
- Expected to finish
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Aug 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
1. CLL/SLL must be diagnosed according to the IWCLL NCI-WG Guidelines (2018 edition) and meet at least one of the criteria requiring treatment. 2. With a measurable disease. 3. ECOG score 0-2. 4. QTcF interval: ≤450ms in males, ≤470ms in females. 5. Adequate bone marrow function independent of growth factor support. 6. Adequate liver, kidney and coagulation function. 7. Males and females of childbearing potential, and their partners voluntarily use effective contraceptive measures throughout the treatment and for at least three months after the last dose of the study drug. Male patients must avoid donation from the first dose of the study drug to three months after the last dose of the study drug. 8. Female patients of childbearing potential have negative serum pregnancy test results within 14 days prior to the first dose of the study drug. 9. Patients must be able to understand and voluntarily sign an informed consent form approved by the Ethics Committee (EC) before commencing any screening or study specific procedures. 10. Must be willing and able to complete research procedures and follow-up examinations. Exclusion Criteria: 1. Any previous CLL specific treatment. 2. Failure to fully recover adequately from prior surgical procedures at the discretion of the investigator. Patients who receive a major surgery within 28 days prior to the first dose of the study drug or who receive a minor surgery (excluding biopsy) within 14 days prior to the initiation of the study. 3. Presence of significant cardiovascular disease within 6 months prior to study entry. 4. A history of significant kidney, neurological, psychiatric, pulmonary, endocrine, metabolic, immune, cardiovascular, or liver disease, which will have an adverse effect on the patient if he/she participates in the study, at the discretion of the investigator. 5. Patients who require warfarin or other anticoagulants or active hemorrhage occur within 2 months before study entry. 6. Known to have hypersensitivity to the drug ingredient or its analogues. 7. Pregnant or lactating female patients and patients who are expected to become pregnant during the study period or within 3 months after the last dose. 8. Patients who have history of other active malignant tumor other than CLL/SLL within 3 years before study entry. 9. With a malabsorption syndrome or other conditions unsuitable for enteral administration. 10. Other clinically significant uncontrolled symptoms. 11. With primary active autoimmune disease and connective tissue disease. 12. Any other circumstances or conditions that would, at the discretion of the investigator, make the patient unsuitable for the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
10 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Guangdong Provincial People's Hospital
RECRUITINGGuangzhou, Guangdong, 510080, China
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Hematology Hospital of the Chinese Academy of Medical Sciences
RECRUITINGTianjin, Tianjin Municipality, 300020, China
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Henan Provincial Cancer Hospital
RECRUITINGZhengzhou, Henan, 450003, China
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Hunan Cancer Hospital
NOT_YET_RECRUITINGChangsha, Hunan, 410031, China
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Nanfang Hospital of Southern Medical University
RECRUITINGGuangzhou, Guangdong, 510515, China
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The First Affiliated Hospital of Bengbu Medical College
NOT_YET_RECRUITINGBengbu, Anhui, 233004, China
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The Second Xiangya Hospital of Center South University
NOT_YET_RECRUITINGChangsha, Hunan, 545001, China
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The affiliated Hospital of Guangdong Medical University
NOT_YET_RECRUITINGZhanjiang, Guangdong, 524013, China
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Tongji Hospital of Tongji University
NOT_YET_RECRUITINGShanghai, Shanghai Municipality, 200065, China
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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
NOT_YET_RECRUITINGWuhan, Hubei, 430023, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Two-Drug combo aims to push CLL into deep remission
- Can a new BTK inhibitor outsmart resistance in CLL?
- Can a new pill outsmart Drug-Resistant leukemia?
- Can engineered immune cells beat tough B-Cell cancers?
- Can a targeted drug outperform chemo for a common blood cancer?
- Can a triple drug combo outsmart High-Risk CLL?