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

Phase 3

Recruiting

• Conditions: Ph+ ALL
• Interventions: Drug: Imatinib; Drug: Olverembatinib

• Registration Number: NCT06051409
• Lead Sponsor: Ascentage Pharma Group Inc.

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.

Detailed Description

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

Study Timeline

• Study Start: 2023-08-31
• Study First Submitted: 2023-09-04
• Study First Submitted QC: 2023-09-17
• Study First Posted: 2023-09-22
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-05
• Last Update Posted: 2024-11-07
• Primary Completion: 2024-12-31
• Study Completion: 2028-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 350

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Imatinib	Imatinib	Imatinib in combination with chemotherapy
Olverembatinib	Olverembatinib	Olverembatinib in combination with chemotherapy

Primary Outcome Measures

Name	Time	Method
Minimal residual disease negativity rate	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

Name	Time	Method
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.	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.
Plasma concentrations of olverembatinib	Cycle 1 to Cycle 3 (each cycle is 28 days)	Blood samples will be collected to measure the plasma concentration of olverembatinib.
The patients' score of EORTC(The European Organization for Research and Treatment of Cancer) QLQ-C30.	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.）

Trial Locations

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, 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, China

West China Hospital of Sichuan University; 🇨🇳 Chengdu, Sichuan, China

Institute of blood transfusion of Chinese Academy of Medical Sciences; 🇨🇳 Tianjin, Tianjin, China