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Can a Chemo-Free pill combo outsmart leukemia at first diagnosis?

NCT ID NCT06319456

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 344 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2024

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    10 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Guangdong Provincial People's Hospital

    RECRUITING

    Guangzhou, Guangdong, 510080, China

  • Hematology Hospital of the Chinese Academy of Medical Sciences

    RECRUITING

    Tianjin, Tianjin Municipality, 300020, China

  • Henan Provincial Cancer Hospital

    RECRUITING

    Zhengzhou, Henan, 450003, China

  • Hunan Cancer Hospital

    NOT_YET_RECRUITING

    Changsha, Hunan, 410031, China

  • Nanfang Hospital of Southern Medical University

    RECRUITING

    Guangzhou, Guangdong, 510515, China

  • The First Affiliated Hospital of Bengbu Medical College

    NOT_YET_RECRUITING

    Bengbu, Anhui, 233004, China

  • The Second Xiangya Hospital of Center South University

    NOT_YET_RECRUITING

    Changsha, Hunan, 545001, China

  • The affiliated Hospital of Guangdong Medical University

    NOT_YET_RECRUITING

    Zhanjiang, Guangdong, 524013, China

  • Tongji Hospital of Tongji University

    NOT_YET_RECRUITING

    Shanghai, Shanghai Municipality, 200065, China

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    NOT_YET_RECRUITING

    Wuhan, Hubei, 430023, China

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