ClinTrial Refer

Trial Acronym
HQP1351AG301

Registration Number
NCT06051409

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)

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.

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.

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.

Trial Location Name

Address

Status

Royal Adelaide Hospital (Haematology)

Port Rd, Adelaide SA 5000, Australia

Recruiting

Primary Contact : Chris Hoare, christine.hoare@sa.gov.au , 08 7074 3290

Royal North Shore Hospital (Haematology)

Reserve Rd, St Leonards NSW 2065, Australia

Recruiting

Primary Contact : Molly Forbes, molly.forbes@health.nsw.gov.au , 02 9926 4173

Ascentage Pharma Group Inc.

Website URL

Link Name

Link URL

Clinicaltrials.gov

https://clinicaltrials.gov/ct2/show/NCT06051409

ANZCTR

http://www.anzctr.org.au/TrialSearch.aspx?searchTxt=NCT06051409

Secondary IDs
N/A

Study Type
Interventional

Intervention Code
Treatment - Drugs

Phase
Phase 3

Minimum Age
18

Maximum Age
100

Date Registered
31/05/2024

Date Closed
N/A

Status
Open

Enrolment Type
By Specialist and/or Surgeon Referral

Mutation Status and Biomarker
Any or not stated

Is it a Cohort Trial?
No

Is this a Tele-Trial?
No

Can healthy volunteer participate?
No

Discipline

Health Condition

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