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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06051409




Registration number
NCT06051409
Ethics application status
Date submitted
4/09/2023
Date registered
22/09/2023
Date last updated
7/11/2024

Titles & IDs
Public title
A Study of Olverembatinib in Patients With Newly Diagnosed Ph+ALL.
Scientific 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)
Secondary ID [1] 0 0
HQP1351AG301
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ph+ ALL 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Olverembatinib
Treatment: Drugs - Imatinib

Experimental: Olverembatinib - Olverembatinib in combination with chemotherapy

Active comparator: Imatinib - Imatinib in combination with chemotherapy


Treatment: Drugs: Olverembatinib
Orally, once every other day (QOD).

Treatment: Drugs: Imatinib
Orally, once daily (QD).
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Minimal residual disease negativity rate
Timepoint [1] 0 0
Cycles 1 to cycle 3 (each cycle is 28 days)
Secondary outcome [1] 0 0
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Timepoint [1] 0 0
Through study completion,an average of 2 years.
Secondary outcome [2] 0 0
Plasma concentrations of olverembatinib
Timepoint [2] 0 0
Cycle 1 to Cycle 3 (each cycle is 28 days)
Secondary outcome [3] 0 0
The patients' score of EORTC(The European Organization for Research and Treatment of Cancer) QLQ-C30.
Timepoint [3] 0 0
Through study completion,an average of 2 years.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/08/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/10/2028
Actual
Sample size
Target
350
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,Washingto
Recruitment hospital [1] 0 0
Royal North Shore Hospital - St. Leonards
Recruitment hospital [2] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [3] 0 0
Alfred Health - Melbourne
Recruitment hospital [4] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
- St. Leonards
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment postcode(s) [4] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Anhui
Country [2] 0 0
China
State/province [2] 0 0
Chongqing
Country [3] 0 0
China
State/province [3] 0 0
Guangzhou
Country [4] 0 0
China
State/province [4] 0 0
Henan
Country [5] 0 0
China
State/province [5] 0 0
Hubei
Country [6] 0 0
China
State/province [6] 0 0
Jiangsu
Country [7] 0 0
China
State/province [7] 0 0
Shanghai
Country [8] 0 0
China
State/province [8] 0 0
Sichuan
Country [9] 0 0
China
State/province [9] 0 0
Tianjin

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Ascentage Pharma Group Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
HealthQuest Pharma Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Weili Zhao, M.D.,Ph.D.
Address 0 0
Shanghai Jiaotong University School of Medicine Ruijin Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Kat Richardson
Address 0 0
Country 0 0
Phone 0 0
+1 202-590-8039
Fax 0 0
Email 0 0
kat.richardson@ascentage.com
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06051409