A Study of Olverembatinib in Patients With Newly Diagnosed Ph+ALL.

Last updated: November 5, 2024
Sponsor: Ascentage Pharma Group Inc.
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

Imatinib

Olverembatinib

Clinical Study ID

NCT06051409
HQP1351AG301
  • Ages > 18
  • All Genders

Study Summary

A global multicenter, open-label, randomized and registrational Phase 3 study to evaluate efficacy and safety of Olverembatinib combined with chemotherapy versus Imatinib combined with chemotherapy in subjects with newly diagnosed Ph+ALL.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Meet the WHO 2016 Ph chromosome or BCR/ABL1 positive Ph+ALL diagnostic and typingcriteria for acute lymphoblastic leukemia. This is a newly diagnosed Ph+ALL.

  2. Expected survival of at least 3 months.

  3. ECOG ≤ 2.

  4. Adequate organ function.

  5. Use effective contraception during treatment and for at least three months after thelast dose of the study drug, and male patients may not donate sperm.

  6. Pregnancy test results of serum samples obtained within 7 days prior to the firstdosing of a fertile female subject were negative.

  7. Understand and voluntarily sign the informed consent approved by the EthicsCommittee (EC) and voluntarily complete the study procedure and follow-upexamination.

Exclusion

Exclusion Criteria:

  1. A history of chronic myeloid leukemia and a diagnosis of acute leukemia with chronicmyeloid leukemia.

  2. Clinical manifestations of central nervous system (CNS) leukemia or ALLextramedullary infiltration, except lymphadenopathy or hepatosplenomegaly.

  3. Previous or current clinical CNS diseases.

  4. Autoimmune diseases that may involve the CNS.

  5. Use therapeutic doses of anticoagulants and/or antiplatelet agents but allow lowdoses of anticoagulants to keep central venous lines open.

  6. Use a therapeutic drug that has drug interaction with the investigational drug dueto other diseases within 7 days prior to the first receipt of the investigationaldrug.

  7. Uncontrolled Heart diseases.

  8. Had any VTE in the 6 months prior to randomization, including but not limited todeep vein thrombosis (DVT) or pulmonary embolism.

  9. Use of prohibited drugs.

  10. The presence of any disease or medical condition that is unstable or may affect itssafety or compliance with the study.

  11. 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 anactive gastrointestinal ulcer.

  14. Contraindications to the use of glucocorticoids, and the researchers judge that theyare not suitable to participate in this study.

  15. Bleeding disorders unrelated to the tumor.

  16. Plan to undergone 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 pregnantduring the study plan or within 3 months of the last dosing.

  19. Other malignant tumors within 2 years.

  20. Any symptom or illness that may interfere with the evaluation of the efficacy andsafety of the investigational drug, or any other condition or condition that is notappropriate for participation in the study.

Study Design

Total Participants: 350
Treatment Group(s): 2
Primary Treatment: Imatinib
Phase: 3
Study Start date:
August 31, 2023
Estimated Completion Date:
October 31, 2028

Study Description

Comparing efficacy and safety of Olverembatinib in combination with chemotherapy (investigational arm) vs. Imatinib in combination with chemotherapy (control arm).

Connect with a study center

  • Royal North Shore Hospital

    St. Leonards, New South Wales
    Australia

    Active - Recruiting

  • Royal Adelaide Hospital

    Adelaide, South Australia 5000
    Australia

    Active - Recruiting

  • Alfred Health

    Melbourne, Victoria 3004
    Australia

    Active - Recruiting

  • Royal Perth Hospital

    Perth, Washington 6000
    Australia

    Active - Recruiting

  • The First Affiliated Hospitalo of Bengbu Medical School

    Bengbu, Anhui 233000
    China

    Site Not Available

  • Xinqiao Hospital of Army Medical University

    Chongqing, Chongqing 214426
    China

    Site Not Available

  • Guangdong Province People's Hospital

    Guangdong, Guangzhou 510080
    China

    Site Not Available

  • Nanfang Hospital of Southern Medical University

    Guangdong, Guangzhou 510515
    China

    Site Not Available

  • Henan Cancer Hospital

    Zhengzhou, Henan 450003
    China

    Site Not Available

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

    Wuhan, Hubei 430022
    China

    Site Not Available

  • The first affiliated hospital of Suzhou University

    Suzhou, Jiangsu 215006
    China

    Active - Recruiting

  • Shanghai Jiao Tong University School of Medicine Ruijin Hospital

    Shanghai, Shanghai 200025
    China

    Site Not Available

  • West China Hospital of Sichuan University

    Chengdu, Sichuan 610044
    China

    Site Not Available

  • Institute of blood transfusion of Chinese Academy of Medical Sciences

    Tianjin, Tianjin 215127
    China

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.