RecruitingPhase 3NCT06051409

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

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)


Sponsor

Ascentage Pharma Group Inc.

Enrollment

350 participants

Start Date

Aug 31, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria7

  • 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.
  • Expected survival of at least 3 months.
  • ECOG ≤ 2.
  • Adequate organ function.
  • 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.
  • Pregnancy test results of serum samples obtained within 7 days prior to the first dosing of a fertile female subject were negative.
  • Understand and voluntarily sign the informed consent approved by the Ethics Committee (EC) and voluntarily complete the study procedure and follow-up examination.

Exclusion Criteria20

  • A history of chronic myeloid leukemia and a diagnosis of acute leukemia with chronic myeloid leukemia.
  • Clinical manifestations of central nervous system (CNS) leukemia or ALL extramedullary infiltration, except lymphadenopathy or hepatosplenomegaly.
  • Previous or current clinical CNS diseases.
  • Autoimmune diseases that may involve the CNS.
  • Use therapeutic doses of anticoagulants and/or antiplatelet agents but allow low doses of anticoagulants to keep central venous lines open.
  • 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.
  • Uncontrolled Heart diseases.
  • Had any VTE in the 6 months prior to randomization, including but not limited to deep vein thrombosis (DVT) or pulmonary embolism.
  • Use of prohibited drugs.
  • The presence of any disease or medical condition that is unstable or may affect its safety or compliance with the study.
  • Medications known to cause prolonged QT interval.
  • Active infections requiring systemic treatment.
  • Disease that severely affects the oral administration and absorption of drugs, or an active gastrointestinal ulcer.
  • Contraindications to the use of glucocorticoids, and the researchers judge that they are not suitable to participate in this study.
  • Bleeding disorders unrelated to the tumor.
  • Plan to undergone major surgery.
  • Allergy to drug ingredients, excipients, or their analogues in the study.
  • Female subjects who are pregnant or breastfeeding or expect to become pregnant during the study plan or within 3 months of the last dosing.
  • Other malignant tumors within 2 years.
  • 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.

Interventions

DRUGOlverembatinib

Orally, once every other day (QOD).

DRUGImatinib

Orally, once daily (QD).


Locations(14)

Royal North Shore Hospital

St Leonards, New South Wales, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Alfred Health

Melbourne, Victoria, Australia

Royal Perth Hospital

Perth, Washington, Australia

The First Affiliated Hospitalo of Bengbu Medical School

Bengbu, Anhui, China

Xinqiao Hospital of Army Medical University

Chongqing, Chongqing Municipality, China

Guangdong Province People's Hospital

Guangdong, Guangzhou, China

Nanfang Hospital of Southern Medical University

Guangdong, Guangzhou, China

Henan Cancer Hospital

Zhengzhou, Henan, China

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

Wuhan, Hubei, China

The first affiliated hospital of Suzhou University

Suzhou, Jiangsu, China

Shanghai Jiao Tong University School of Medicine Ruijin Hospital

Shanghai, Shanghai Municipality, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Institute of blood transfusion of Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, China

View Full Details on ClinicalTrials.gov

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NCT06051409