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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06051409
Recruitment Status : Recruiting
First Posted : September 22, 2023
Last Update Posted : September 25, 2023
Sponsor:
Collaborator:
HealthQuest Pharma Inc.
Information provided by (Responsible Party):
Ascentage Pharma Group Inc.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Ph+ ALL Drug: Olverembatinib Drug: Imatinib Phase 3

Detailed Description:
Comparing efficacy and safety of Olverembatinib in combination with chemotherapy (investigational arm) vs. Imatinib in combination with chemotherapy (control arm).
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pivotal Registrational Phase 3 Study of Olverembatinib Combined With Chemotherapy Versus Imatinib Combined With Chemotherapy in Patients With Newly Diagnosed Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia (Ph+ALL)
Actual Study Start Date : September 2, 2023
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : October 31, 2028

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Olverembatinib
Olverembatinib in combination with chemotherapy
 Drug: Olverembatinib
Orally, once every other day (QOD).
Active Comparator: Imatinib
Imatinib in combination with chemotherapy
 Drug: Imatinib
Orally, once daily (QD).


Outcome Measures
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Primary Outcome Measures :
  1. Minimal residual disease negativity rate [ Time Frame: Cycles 1 to cycle 3 (each cycle is 28 days) ]
    The minimal residual disease negativity rate of olverembatinib combined chemotherapy versus imatinib combined chemotherapy in subjects with newly diagnosed Ph+ALL.


Secondary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0. [ Time Frame: Through study completion,an average of 2 years. ]
    According to CTCAE v5.0, the number and frequency of adverse events of test drug were assessed.

  2. Plasma concentrations of olverembatinib [ Time Frame: Cycle 1 to Cycle 3 (each cycle is 28 days) ]
    Blood samples will be collected to measure the plasma concentration of olverembatinib.

  3. The patients' score of EORTC(The European Organization for Research and Treatment of Cancer) QLQ-C30. [ Time Frame: Through study completion,an average of 2 years. ]
    To evaluate patient-reported outcome in patients treated with olverembatinib plus chemotherapy.（The scale ranges from 0 to 100, with a lower score indicating better quality of life and a higher score on the scale indicating worse symptoms.）


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Meet the WHO 2016 Ph chromosome or BCR/ABL1 positive Ph+ALL diagnostic and typing criteria 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 the last 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 first dosing of a fertile female subject were negative.
  7. Understand and voluntarily sign the informed consent approved by the Ethics Committee (EC) and voluntarily complete the study procedure and follow-up examination.

Exclusion Criteria:

  1. A history of chronic myeloid leukemia and a diagnosis of acute leukemia with chronic myeloid leukemia.
  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 therapeutic doses of anticoagulants and/or antiplatelet agents but allow low doses of anticoagulants to keep central venous lines open.
  6. Use a therapeutic drug that has drug interaction with the investigational drug due to other diseases within 7 days prior to the first receipt of the investigational drug.
  7. Uncontrolled Heart diseases.
  8. Had any VTE 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. The presence of any disease or medical condition that is unstable or may affect its safety 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 an active gastrointestinal ulcer.
  14. Contraindications to the use of glucocorticoids, and the researchers judge that they are 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 pregnant during 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 and safety of the investigational drug, or any other condition or condition that is not appropriate for participation in the study.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06051409


Contacts
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Contact: Yifan Zhai, M.D., Ph.D. +86-20-28069260 yzhai@ascentage.com
Contact: Bo Huang Bo.Huang@ascentage.com

Locations
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China, Chongqing
Xinqiao Hospital of Army Medical University Not yet recruiting
Chongqing, Chongqing, China, 214426
Contact: Cheng Zhang, Ph.D.         
Principal Investigator: Cheng Zhang, Ph.D.         
China, Guangzhou
Guangdong Province People's Hospital Not yet recruiting
Guangdong, Guangzhou, China, 510080
Contact: Jianyu Weng, Ph.D.         
Principal Investigator: Jianyu Weng, Ph.D.         
Nanfang Hospital of Southern Medical University Not yet recruiting
Guangdong, Guangzhou, China, 510515
Contact: Hongsheng Zhou, Ph.D.         
Principal Investigator: Hongsheng Zhou, Ph.D.         
China, Henan
Henan Cancer Hospital Not yet recruiting
Zhengzhou, Henan, China, 450003
Contact: Xudong Wei, Ph.D.         
Principal Investigator: Xudong Wei, Ph.D.         
China, Hubei
Wuhan Union Hospital of Tongji Medical College of Huazhong University of Science and Technology Not yet recruiting
Wuhan, Hubei, China, 430022
Contact: Mei Hong, Ph.D.         
Principal Investigator: Mei Hong, Ph.D.         
China, Jiangsu
The first affiliated hospital of Suzhou University Recruiting
Suzhou, Jiangsu, China, 215006
Contact: Suning Chen, M.D.,Ph.D.         
Principal Investigator: Suning Chen, M.D.,Ph.D.         
China, Shanghai
Shanghai Jiao Tong University School of Medicine Ruijin Hospital Not yet recruiting
Shanghai, Shanghai, China, 200025
Contact: Weili Zhao, M.D.,Ph.D.         
Principal Investigator: Weili Zhao, M.D.,Ph.D.         
China, Sichuan
West China Hospital of Sichuan University Not yet recruiting
Chengdu, Sichuan, China, 610044
Contact: Yu Wu, Ph.D.         
Principal Investigator: Yu Wu, Ph.D.         
China, Tianjin
Institute of blood transfusion of Chinese Academy of Medical Sciences Not yet recruiting
Tianjin, Tianjin, China, 215127
Contact: Ying Wang, Ph.D.         
Principal Investigator: Ying Wang, Ph.D.         
Sponsors and Collaborators
Ascentage Pharma Group Inc.
HealthQuest Pharma Inc.
Investigators
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Principal Investigator: Weili Zhao, M.D.,Ph.D. Shanghai Jiaotong University School of Medicine Ruijin Hospital
Principal Investigator: Suning Chen, M.D.,Ph.D. First Affiliated Hospital of Suzhou Medical College
More Information
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Responsible Party: Ascentage Pharma Group Inc.
ClinicalTrials.gov Identifier: NCT06051409    
Other Study ID Numbers: HQP1351AG301
First Posted: September 22, 2023    Key Record Dates
Last Update Posted: September 25, 2023
Last Verified: September 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ascentage Pharma Group Inc.:
Ph+ ALL
Olverembatinib Tablets
Additional relevant MeSH terms:
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Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action