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New combo therapy aims to outsmart resistant blood cancer

NCT ID NCT06104566

Disease control Sponsor: Ascentage Pharma Group Inc. Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 3 trial is testing whether adding a new drug called lisaftoclax to a standard BTK inhibitor works better than the BTK inhibitor alone for people with CLL or SLL whose cancer has come back or not responded well to prior BTK inhibitor treatment. About 400 participants will be randomly assigned to one of two groups. The main goal is to see if the combination helps people live longer without their cancer getting worse.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
lisaftoclax (APG-2575) combined with a BTK inhibitor
What this could lead to
If successful, this combination could offer a more effective treatment option for people with CLL/SLL whose disease has progressed on BTK inhibitor therapy alone.
What could go wrong
This is an early-stage Phase 3 trial, so results are not guaranteed. The combination may cause more side effects than the single drug, and it may not improve survival or delay disease progression for all patients.
Why investors are watching

Ascentage Pharma is running a late-stage trial of its drug lisaftoclax combined with BTK inhibitors in patients with CLL/SLL who have already tried a BTK inhibitor. For a small company, this phase 3 study is a key test of whether the drug can help patients who have run out of standard options, and the outcome could shape the company's future.

If it works: If the trial shows the combination works and is safe, Ascentage could gain a new treatment option for a difficult-to-treat blood cancer, which might lead to regulatory approval and a broader product lineup.

If it fails: The trial could fail to show benefit or face delays, which would set back the company's plans and hurt its prospects. Many phase 3 trials do not succeed, so a negative result is a real possibility.

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 400 people

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

Started

Dec 2023

Expected to finish

Oct 2027

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 to 99 years

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.

Inclusion Criteria: 1. Age ≥ 18 years. 2. Patients that have documented CLL/SLL who meet iwCLL 2018 criteria for CLL treatment guidelines are eligible for treatment and must be receiving BTKi monotherapy for at least 12 months 3. ECOG Performance Status grade 0-2 4. Adequate bone marrow function independent of growth factor or transfusion support within 2 weeks of screening initiation as follows: * Absolute neutrophil count ≥ 1.0 × 109/L * Platelet counts ≥ 75 × 109/L; in cases of thrombocytopenia * Total hemoglobin ≥ 9 g/dL, 5. Adequate renal function * Creatinine clearance must be \> 50 ml/min directly measured with 24hr urine collection or calculated according to the modified formula of Cockcroft and Gault (for men: GFR ≈ ((140 - age) x actual body weight)/(72 x creatinine), for women x 0.85) or an equally accurate method. * For patients with creatinine values within the normal range, the calculation of clearance is not necessary. Dehydrated patients with an estimated creatinine clearance less than 50 ml/min may be eligible if a repeat estimate after adequate hydration is \> 50 ml/min. 6. Adequate liver function as indicated by: * Total bilirubin ≤ 1.5 x ULN, except patients with known Gilbert's Syndrome * Aspartate aminotransferase (AST) ≤ 2.5 x the institutional ULN value * Alanine aminotransferase (ALT) ≤ 2.5 x the institutional ULN value, * International normalized Ratio (INR), Prothrombin Time (PT) or Activated Partial Thromboplastin time (APTT) ≤ 1.5×ULN. 7. Ability and willingness to provide written informed consent and to adhere to the study visit schedule and other protocol requirements

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Conditions

The condition(s) this trial relates to.

chronic lymphocytic leukemia/small lymphocytic lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

CLL/SLL

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    120 sites in 17 countries. 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

  • Ascentage Investigative Site

    RECRUITING

    Tuscon, Arizona, 85742, United States

  • Ascentage Investigative Site

    RECRUITING

    Anaheim, California, 92805, United States

  • Ascentage Investigative Site

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Ascentage Investigative Site

    RECRUITING

    Miami Beach, Florida, 33140, United States

  • Ascentage Investigative Site

    RECRUITING

    Peoria, Illinois, 61615, United States

  • Ascentage Investigative Site

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Ascentage Investigative Site

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • Ascentage Investigative Site

    RECRUITING

    Greenville, North Carolina, 27834, United States

  • Ascentage Investigative Site

    RECRUITING

    Houston, Texas, 77030, United States

  • Ascentage Investigative Site

    RECRUITING

    Kingswood, Texas, 77339, United States

  • Ascentage Investigative Site

    RECRUITING

    Richmond, Virginia, 23298, United States

  • Ascentage Investigative Site

    COMPLETED

    Gosford, 2250, Australia

  • Ascentage Investigative Site

    COMPLETED

    Perth, 6000, Australia

  • Ascentage Investigative Site

    COMPLETED

    Westmead, 2145, Australia

  • Ascentage Investigative Site

    RECRUITING

    Ghent, 9000, Belgium

  • Ascentage Investigative Site

    RECRUITING

    La Louvière, 7100, Belgium

  • Ascentage Investigative Site

    RECRUITING

    Leuven, 3000, Belgium

  • Ascentage Investigative Site

    RECRUITING

    Ottignies, 1349, Belgium

  • Ascentage Investigative Site

    RECRUITING

    Roeselare, 8800, Belgium

  • Ascentage Investigative Site

    RECRUITING

    Sofia, 1407, Bulgaria

  • Ascentage Investigative Site

    RECRUITING

    Sofia, 1431, Bulgaria

  • Ascentage Investigative Site

    RECRUITING

    Sofia, 1756, Bulgaria

  • Ascentage Investigative Site

    RECRUITING

    Sofia, 1797, Bulgaria

  • Ascentage Investigative Site

    RECRUITING

    Halifax, Nova Scotia, B3S 0H6, Canada

  • Ascentage Investigative Site

    RECRUITING

    Hefei, Anhui, 230031, China

  • Ascentage Investigative Site

    RECRUITING

    Beijing, Beijing Municipality, 100005, China

  • Ascentage Investigative Site

    RECRUITING

    Fuzhou, Fujian, 350001, China

  • Ascentage Investigative Site

    RECRUITING

    Foshan, Guangdong, 528000, China

  • Ascentage Investigative Site

    RECRUITING

    Guangzhou, Guangdong, 510050, China

  • Ascentage Investigative Site

    RECRUITING

    Nanning, Guangxie, 530022, China

  • Ascentage Investigative Site

    RECRUITING

    Zhengzhou, Henan, 450003, China

  • Ascentage Investigative Site

    RECRUITING

    Wuhan, Hubei, 430022, China

  • Ascentage Investigative Site

    RECRUITING

    Chenzhou, Hunan, 423000, China

  • Ascentage Investigative Site

    RECRUITING

    Nanjing, Jiangsu, 210029, China

  • Ascentage Investigative Site

    RECRUITING

    Suzhou, Jiangsu, 215026, China

  • Ascentage Investigative Site

    RECRUITING

    Wuxi, Jiangsu, 214023, China

  • Ascentage Investigative Site

    RECRUITING

    Nanchang, Jiangxi, 330008, China

  • Ascentage Investigative Site

    RECRUITING

    Xi'an, Shaanxi, 710061, China

  • Ascentage Investigative Site

    RECRUITING

    Binzhou, Shandong, 256600, China

  • Ascentage Investigative Site

    RECRUITING

    Taiyuan, Shanxi, 030013, China

  • Ascentage Investigative Site

    RECRUITING

    Luzhou, Sichuan, 646099, China

  • Ascentage Investigative Site

    RECRUITING

    Yibin, Sichuan, 644099, China

  • Ascentage Investigative Site

    RECRUITING

    Guangzhou, 510090, China

  • Ascentage Investigative Site

    RECRUITING

    Hradec Králové, 500 05, Czechia

  • Ascentage Investigative Site

    RECRUITING

    Clermont-Ferrand, 63000, France

  • Ascentage Investigative Site

    RECRUITING

    Le Mans, 72037, France

  • Ascentage Investigative Site

    RECRUITING

    Lyon, 69373, France

  • Ascentage Investigative Site

    RECRUITING

    Nantes, 44000, France

  • Ascentage Investigative Site

    RECRUITING

    Nantes, 44277, France

  • Ascentage Investigative Site

    RECRUITING

    Nîmes, 30029, France

  • Ascentage Investigative Site

    RECRUITING

    Orléans, 45100, France

  • Ascentage Investigative Site

    RECRUITING

    Poitiers, 86000, France

  • Ascentage Investigative Site

    RECRUITING

    Pontoise, 95300, France

  • Ascentage Investigative Site

    RECRUITING

    Strasbourg, 67091, France

  • Ascentage Investigative Site

    RECRUITING

    Tours, 37000, France

  • Ascentage Investigative Site

    RECRUITING

    Dresden, 01307, Germany

  • Ascentage Investigative Site

    RECRUITING

    Dresden, 48149, Germany

  • Ascentage Investigative Site

    RECRUITING

    München, 81377, Germany

  • Ascentage Investigative Site

    RECRUITING

    Gandhinagar, Gujarat, 382428, India

  • Ascentage Investigative Site

    RECRUITING

    Gurugramam, Haryana, 122001, India

  • Ascentage Investigative Site

    RECRUITING

    Gurugramam, Haryana, 122002, India

  • Ascentage Investigative Site

    RECRUITING

    Jhajjar, Haryana, 124105, India

  • Ascentage Investigative Site

    RECRUITING

    Bangalore, Karnataka, 560027, India

  • Ascentage Investigative Site

    RECRUITING

    Mysuru, Karnataka, 570023, India

  • Ascentage Investigative Site

    RECRUITING

    Navi Mumbai, Maharashtra, 400614, India

  • Ascentage Investigative Site

    RECRUITING

    Pune, Maharashtra, 411001, India

  • Ascentage Investigative Site

    RECRUITING

    Delhi, National Capital Territory of Delhi, 110085, India

  • Ascentage Investigative Site

    RECRUITING

    New Delhi, New Delhi, 110017, India

  • Ascentage Investigative Site

    RECRUITING

    New Delhi, New Delhi, 110029, India

  • Ascentage Investigative Site

    RECRUITING

    New Delhi, New Delhi, 110076, India

  • Ascentage Investigative Site

    RECRUITING

    New Delhi, New, 110017, India

  • Ascentage Investigative Site

    RECRUITING

    Madurai, Tamil Nadu, 625020, India

  • Ascentage Investigative Site

    RECRUITING

    Hyderabad, Telangana, 500033, India

  • Ascentage Investigative Site

    RECRUITING

    Kolkata, West Bengal, 700014, India

  • Ascentage Investigative Site

    RECRUITING

    Kolkata, West Bengal, 700054, India

  • Ascentage Investigative Site

    RECRUITING

    Puducherry, 605006, India

  • Ascentage Investigative Site

    RECRUITING

    Haifa, 31048, Israel

  • Ascentage Investigative Site

    RECRUITING

    Haifa, 3109601, Israel

  • Ascentage Investigative Site

    RECRUITING

    Jerusalem, 91120, Israel

  • Ascentage Investigative Site

    RECRUITING

    Kfar Saba, 4428164, Israel

  • Ascentage Investigative Site

    RECRUITING

    Tel Aviv, 62431, Israel

  • Ascentage Investigative Site

    RECRUITING

    Aviano, 33081, Italy

  • Ascentage Investigative Site

    RECRUITING

    Brescia, 25123, Italy

  • Ascentage Investigative Site

    RECRUITING

    Cona, 44124, Italy

  • Ascentage Investigative Site

    RECRUITING

    Genova, 16132, Italy

  • Ascentage Investigative Site

    RECRUITING

    Lecce, 73100, Italy

  • Ascentage Investigative Site

    RECRUITING

    Meldola, 47014, Italy

  • Ascentage Investigative Site

    RECRUITING

    Milan, 20141, Italy

  • Ascentage Investigative Site

    RECRUITING

    Milan, 20132, Italy

  • Ascentage Investigative Site

    RECRUITING

    Padova, 35122, Italy

  • Ascentage Investigative Site

    RECRUITING

    Piacenza, 29121, Italy

  • Ascentage Investigative Site

    RECRUITING

    Ravenna, 48121, Italy

  • Ascentage Investigative Site

    RECRUITING

    Reggio Emilia, 42123, Italy

  • Ascentage Investigative Site

    RECRUITING

    Rimini, 47923, Italy

  • Ascentage Investigative Site

    RECRUITING

    Roma, 00128, Italy

  • Ascentage Investigative Site

    RECRUITING

    Roma, 00168, Italy

  • Ascentage Investigative Site

    RECRUITING

    Torino, 10126, Italy

  • Ascentage Investigative Site

    RECRUITING

    Udine, 33100, Italy

  • Ascentage Investigative Site

    RECRUITING

    Bydgoszcz, 85-048, Poland

  • Ascentage Investigative Site

    RECRUITING

    Krakow, 30-727, Poland

  • Ascentage Investigative Site

    RECRUITING

    Lodz, 93-513, Poland

  • Ascentage Investigative Site

    RECRUITING

    Skorzewo, 60-185, Poland

  • Ascentage Investigative Site

    RECRUITING

    Bucharest, 022328, Romania

  • Ascentage Investigative Site

    RECRUITING

    Cluj-Napoca, 400015, Romania

  • Ascentage Investigative Site

    RECRUITING

    Timișoara, 300254, Romania

  • Ascentage Investigative Site

    ACTIVE_NOT_RECRUITING

    Saint Petersburg, Kaluga Oblast, 248008, Russia

  • Ascentage Investigative Site

    ACTIVE_NOT_RECRUITING

    Kirov, Kirov Oblast, 610027, Russia

  • Ascentage Investigative Site

    ACTIVE_NOT_RECRUITING

    Kaluga, 246007, Russia

  • Ascentage Investigative Site

    ACTIVE_NOT_RECRUITING

    Kazan', 420029, Russia

  • Ascentage Investigative Site

    ACTIVE_NOT_RECRUITING

    Moscow, 115522, Russia

  • Ascentage Investigative Site

    ACTIVE_NOT_RECRUITING

    Moscow, 123182, Russia

  • Ascentage Investigative Site

    ACTIVE_NOT_RECRUITING

    Moscow, 125284, Russia

  • Ascentage Investigative Site

    ACTIVE_NOT_RECRUITING

    Petrozavodsk, 185019, Russia

  • Ascentage Investigative Site

    ACTIVE_NOT_RECRUITING

    Saint Petersburg, 197022, Russia

  • Ascentage Investigative Site

    ACTIVE_NOT_RECRUITING

    Saint Petersburg, 197341, Russia

  • Ascentage Investigative Site

    ACTIVE_NOT_RECRUITING

    Sochi, 354057, Russia

  • Ascentage Investigative Site

    ACTIVE_NOT_RECRUITING

    Syktyvkar, 167904, Russia

  • Ascentage Investigative Site

    RECRUITING

    Bratislava, 833 10, Slovakia

  • Ascentage Investigative Site

    RECRUITING

    Martin, 036 59, Slovakia

  • Ascentage Investigative Site

    RECRUITING

    Barcelona, 08003, Spain

  • Ascentage Investigative Site

    RECRUITING

    Barcelona, 08035, Spain

  • Ascentage Investigative Site

    RECRUITING

    Palma de Mallorca, 07120, Spain

  • Ascentage Investigative Site

    RECRUITING

    Santander, 39008, Spain

  • Ascentage Investigative Site

    RECRUITING

    Valencia, 46015, Spain

  • Ascentage Investigative Site

    RECRUITING

    Kepez, 07025, Turkey (Türkiye)

  • Ascentage Investigative Site

    RECRUITING

    Trabzon, 31080, Turkey (Türkiye)

  • Ascentage Investigative Site

    RECRUITING

    Birmingham, B15 2GW, United Kingdom

  • Ascentage Investigative Site

    RECRUITING

    Bournemouth, BH7 7DW, United Kingdom

  • Ascentage Investigative Site

    RECRUITING

    Liverpool, L7 8YA, United Kingdom

  • Ascentage Investigative Site

    RECRUITING

    London, SW3 6JJ, United Kingdom

  • Ascentage Investigative Site

    RECRUITING

    Manchester, M20 4BX, United Kingdom

  • Ascentage Investigative Site

    RECRUITING

    Stoke-on-Trent, ST4 6QG, United Kingdom

  • Ascentage Investigative Site

    RECRUITING

    Swansea, SA2 8QA, United Kingdom

  • Ascentage Investigative Site

    RECRUITING

    West Bromwich, B71 4HJ, United Kingdom

  • Ascentage Investigative Site

    RECRUITING

    Wolverhampton, WV10 0QP, United Kingdom

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