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New drug combo aims to beat leukemia in phase 3 trial

NCT ID NCT06051409

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 study tests whether adding the experimental drug olverembatinib to standard chemotherapy works better than the usual targeted therapy (a TKI) plus chemotherapy for people newly diagnosed with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). The trial plans to enroll 350 participants worldwide. The main goal is to see if the new combination leads to a higher rate of complete remission with no detectable cancer cells.

What this could mean

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

Active substance
Olverembatinib (a targeted cancer drug taken by mouth every other day)
What this could lead to
If this works, it could offer a more effective first-line treatment option for people with Philadelphia chromosome-positive acute lymphoblastic leukemia, potentially improving remission rates and survival.
What could go wrong
This is a phase 3 trial, but the drug is still experimental. It may not prove better than existing TKIs, and side effects from the combination with chemotherapy could be significant.

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 350 people

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

Started

Aug 2023

Expected to finish

Jun 2029

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.

Inclusion Criteria: 1. Newly diagnosed Philadelphia chromosome-positive (Ph+) Acute Lymphoblastic Leukemia (ALL) 2. Expected survival of at least 3 months 3. ECOG ≤ 2 4. Adequate organ function Exclusion Criteria: 1. A history of chronic myeloid leukemia (CML) 2. Clinical manifestations of central nervous system (CNS) leukemia or ALL extramedullary infiltration, except lymphadenopathy or hepatosplenomegaly 3. Previous or current clinical CNS diseases 4. Autoimmune diseases that may involve the CNS 5. Use of therapeutic doses of anticoagulants and/or antiplatelet agents; low doses of anticoagulants or antiplatelet agents are allowed 6. Use a therapeutic drug that has drug interaction with the investigational drug due to other diseases within 7 days or within 5 half-lives (whichever is shorter) prior to the first receipt of the investigational drug 7. Uncontrolled heart diseases 8. Any venous thromboembolism in the 6 months prior to randomization, including but not limited to deep vein thrombosis (DVT) or pulmonary embolism 9. Use of prohibited drugs 10. Disease or medical condition that is unstable or may affect its safety or compliance with the study 11. Use of medications known to cause prolonged QT interval 12. Active infections requiring systemic treatment 13. Disease that severely affects the oral administration and absorption of drugs, or an active gastrointestinal ulcer 14. Contraindications to the use of glucocorticoids 15. Bleeding disorders unrelated to ALL 16. Plan to undergo major surgery 17. Allergy to drug ingredients, excipients, or their analogues in the study 18. Female subjects who are pregnant or breastfeeding or expect to become pregnant during the study period 19. Other malignant tumors within 2 years 20. Any symptom or illness that may interfere with the evaluation of the efficacy and safety of the investigational drug, or any other condition or condition that is not appropriate for participation in the study

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Conditions

The condition(s) this trial relates to.

acute lymphoblastic leukemia B-lymphoblastic leukemia/lymphoma with t(9;22)(q34.1;q11.2) leukemia, acute lymphocytic, susceptibility to, 1 Precursor Cell Lymphoblastic Leukemia-Lymphoma

As listed by the trial registrant

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

Leukemia, lymphoblastic, acute, philadelphia-positive PH+ ALL

How to take part

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

  1. The places running it

    86 sites in 11 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

  • Alfred Health

    ACTIVE_NOT_RECRUITING

    Melbourne, Victoria, 3004, Australia

  • Ascentage Investigative Site #1044

    NOT_YET_RECRUITING

    Birmingham, Alabama, 35233, United States

  • Ascentage Investigative Site #1045

    NOT_YET_RECRUITING

    Augusta, Georgia, 30912, United States

  • Ascentage Investigative Site #1059

    NOT_YET_RECRUITING

    Los Angeles, California, 90095, United States

  • Ascentage Investigative Site #1062

    NOT_YET_RECRUITING

    Duarte, California, 91010, United States

  • Ascentage Investigative Site #1064

    NOT_YET_RECRUITING

    Hackensack, New Jersey, 07601, United States

  • Ascentage Investigative Site #1069

    NOT_YET_RECRUITING

    Indianapolis, Indiana, 46237, United States

  • Ascentage Investigative Site #1084

    NOT_YET_RECRUITING

    Lexington, Kentucky, 40536, United States

  • Ascentage Investigative Site #1098

    NOT_YET_RECRUITING

    New Brunswick, New Jersey, 08901, United States

  • Ascentage Investigative Site #1134

    NOT_YET_RECRUITING

    Los Angeles, California, 90048, United States

  • Ascentage Investigative Site #1142

    NOT_YET_RECRUITING

    Miami, Florida, 33155, United States

  • Ascentage Investigative Site #1151

    NOT_YET_RECRUITING

    The Bronx, New York, 10461, United States

  • Ascentage Investigative Site #1155

    NOT_YET_RECRUITING

    Morgantown, West Virginia, 26506, United States

  • Ascentage Investigative Site #1158

    NOT_YET_RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Ascentage Investigative Site #1160

    NOT_YET_RECRUITING

    Stony Brook, New York, 11794, United States

  • Ascentage Investigative Site #1501

    NOT_YET_RECRUITING

    Houston, Texas, 77030, United States

  • Ascentage Investigative Site #1806

    NOT_YET_RECRUITING

    Seattle, Washington, 98104, United States

  • Ascentage Investigative Site #5013

    NOT_YET_RECRUITING

    Nantes, 44000, France

  • Ascentage Investigative Site #5018

    NOT_YET_RECRUITING

    Toulouse, 31059, France

  • Ascentage Investigative Site #5019

    NOT_YET_RECRUITING

    Pessac, 33604, France

  • Ascentage Investigative Site #5020

    NOT_YET_RECRUITING

    Le Chesnay, 78150, France

  • Ascentage Investigative Site #5021

    NOT_YET_RECRUITING

    Lyon, 69008, France

  • Ascentage Investigative Site #5022

    NOT_YET_RECRUITING

    Poitiers, 86021, France

  • Ascentage Investigative Site #5024

    NOT_YET_RECRUITING

    Pierre-Bénite, 69495, France

  • Ascentage Investigative Site #5025

    NOT_YET_RECRUITING

    Nice, 06200, France

  • Ascentage Investigative Site #5529

    NOT_YET_RECRUITING

    Meldola, 47014, Italy

  • Ascentage Investigative Site #5531

    NOT_YET_RECRUITING

    Roma, 00138, Italy

  • Ascentage Investigative Site #5533

    NOT_YET_RECRUITING

    Monza, 20900, Italy

  • Ascentage Investigative Site #5536

    NOT_YET_RECRUITING

    Varese, 21100, Italy

  • Ascentage Investigative Site #5538

    NOT_YET_RECRUITING

    Bologna, 40138, Italy

  • Ascentage Investigative Site #5539

    NOT_YET_RECRUITING

    Milan, 20132, Italy

  • Ascentage Investigative Site #5540

    NOT_YET_RECRUITING

    Ravenna, 48121, Italy

  • Ascentage Investigative Site #5550

    NOT_YET_RECRUITING

    Torino, 10126, Italy

  • Ascentage Investigative Site #6011

    NOT_YET_RECRUITING

    Madrid, 28041, Spain

  • Ascentage Investigative Site #6013

    NOT_YET_RECRUITING

    Madrid, 28007, Spain

  • Ascentage Investigative Site #6016

    NOT_YET_RECRUITING

    Madrid, 20834, Spain

  • Ascentage Investigative Site #6017

    NOT_YET_RECRUITING

    Valencia, 6017, Spain

  • Ascentage Investigative Site #6018

    NOT_YET_RECRUITING

    Badalona, 08916, Spain

  • Ascentage Investigative Site #6019

    NOT_YET_RECRUITING

    Badalona, 08916, Spain

  • Ascentage Investigative Site #6020

    NOT_YET_RECRUITING

    Barcelona, 08035, Spain

  • Ascentage Investigative Site #6021

    NOT_YET_RECRUITING

    Santander, 39008, Spain

  • Ascentage Investigative Site #6035

    NOT_YET_RECRUITING

    Madrid, 28006, Spain

  • Ascentage Investigative Site #6048

    NOT_YET_RECRUITING

    Cáceres, 10003, Spain

  • Ascentage Investigative Site #6049

    NOT_YET_RECRUITING

    Madrid, 20840, Spain

  • Ascentage Investigative Site #6050

    NOT_YET_RECRUITING

    Seville, 41010, Spain

  • Ascentage Investigative Site #6302

    NOT_YET_RECRUITING

    Prague, 10034, Czechia

  • Ascentage Investigative Site #6304

    NOT_YET_RECRUITING

    Ostrava, 70852, Czechia

  • Ascentage Investigative Site #6305

    NOT_YET_RECRUITING

    Hradec Králové, 50005, Czechia

  • Ascentage Investigative Site #6309

    NOT_YET_RECRUITING

    Prague, 12800, Czechia

  • Ascentage Investigative Site #6502

    NOT_YET_RECRUITING

    Cluj-Napoca, 400015, Romania

  • Ascentage Investigative Site #6503

    NOT_YET_RECRUITING

    Bucharest, 020125, Romania

  • Ascentage Investigative Site #6504

    NOT_YET_RECRUITING

    Iași, 700483, Romania

  • Ascentage Investigative Site #6507

    NOT_YET_RECRUITING

    Craiova, 200143, Romania

  • Ascentage Investigative Site #6602

    NOT_YET_RECRUITING

    Singapore, 119074, Singapore

  • Ascentage Investigative Site #6603

    NOT_YET_RECRUITING

    Singapore, 169608, Singapore

  • Ascentage Investigative Site #6604

    NOT_YET_RECRUITING

    Singapore, 308433, Singapore

  • Ascentage Investigative Site #7002

    NOT_YET_RECRUITING

    Birmingham, B15 2GW, United Kingdom

  • Ascentage Investigative Site #7019

    NOT_YET_RECRUITING

    London, SW3 6JJ, United Kingdom

  • Ascentage Investigative Site #7034

    NOT_YET_RECRUITING

    Glasgow, G12 0YN, United Kingdom

  • Ascentage Investigative Site #8201

    NOT_YET_RECRUITING

    Seoul, 03080, South Korea

  • Ascentage Investigative Site #8202

    NOT_YET_RECRUITING

    Seoul, 05505, South Korea

  • Ascentage Investigative Site #8203

    NOT_YET_RECRUITING

    Seoul, 06591, South Korea

  • Ascentage Investigative Site #8206

    NOT_YET_RECRUITING

    Busan, 49201, South Korea

  • Ascentage Investigative Site #8207

    NOT_YET_RECRUITING

    Busan, 49241, South Korea

  • Ascentage Investigative Site #8208

    NOT_YET_RECRUITING

    Uijeongbu-si, 11759, South Korea

  • Ascentage Investigative Site #8647

    NOT_YET_RECRUITING

    Brno, 62500, Czechia

  • Ascentage Investigative Site #9201

    NOT_YET_RECRUITING

    Ankara, 06100, Turkey (Türkiye)

  • Ascentage Investigative Site #9202

    NOT_YET_RECRUITING

    Izmir, 35100, Turkey (Türkiye)

  • Ascentage Investigative Site #9203

    NOT_YET_RECRUITING

    Istanbul, 34381, Turkey (Türkiye)

  • Ascentage Investigative Site #9204

    NOT_YET_RECRUITING

    Ankara, 06170, Turkey (Türkiye)

  • Ascentage Investigative Site #9205

    NOT_YET_RECRUITING

    Antalya, 07025, Turkey (Türkiye)

  • Ascentage Investigative Site #9208

    NOT_YET_RECRUITING

    Mersin, 33200, Turkey (Türkiye)

  • Ascentage Investigative Site #9209

    NOT_YET_RECRUITING

    Ankara, 06560, Turkey (Türkiye)

  • Ascentage Investigative Site #9210

    NOT_YET_RECRUITING

    Tekirdağ, 59030, Turkey (Türkiye)

  • Ascentage Investigative Site #9211

    NOT_YET_RECRUITING

    Kayseri, 38039, Turkey (Türkiye)

  • Ascentage Investigative Site #9212

    NOT_YET_RECRUITING

    Ankara, 06200, Turkey (Türkiye)

  • Ascentage Investigative Site #9220

    NOT_YET_RECRUITING

    Samsun, 55139, Turkey (Türkiye)

  • Guangdong Province People's Hospital

    RECRUITING

    Guangdong, Guangzhou, 510080, China

  • Henan Cancer Hospital

    RECRUITING

    Zhengzhou, Henan, 450003, China

  • Institute of Blood Transfusion of Chinese Academy of Medical Sciences

    RECRUITING

    Tianjin, Tianjin Municipality, 215127, China

  • Nanfang Hospital of Southern Medical University

    RECRUITING

    Guangdong, Guangzhou, 510515, China

  • Royal Adelaide Hospital

    ACTIVE_NOT_RECRUITING

    Adelaide, South Australia, 5000, Australia

  • Royal North Shore Hospital

    ACTIVE_NOT_RECRUITING

    St Leonards, New South Wales, Australia

  • Royal Perth Hospital

    ACTIVE_NOT_RECRUITING

    Perth, Washington, 6000, Australia

  • Shanghai Jiao Tong University School of Medicine Ruijin Hospital

    NOT_YET_RECRUITING

    Shanghai, Shanghai Municipality, 200025, China

  • The First Affiliated Hospital of Bengbu Medical School

    NOT_YET_RECRUITING

    Bengbu, Anhui, 233000, China

  • The First Affiliated Hospital of Suzhou University

    RECRUITING

    Suzhou, Jiangsu, 215006, China

  • West China Hospital of Sichuan University

    RECRUITING

    Chengdu, Sichuan, 610044, China

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

    RECRUITING

    Wuhan, Hubei, 430022, China

  • Xinqiao Hospital of Army Medical University

    RECRUITING

    Chongqing, Chongqing Municipality, 214426, China

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Other studies related to the condition(s) this trial covers.