A Study of Olverembatinib in Patients With Newly Diagnosed Ph+ ALL (POLARIS-1)

About

Brief Summary

A global multicenter, open-label, randomized and registrational Phase 3 study to evaluate efficacy and safety of olverembatinib combined with chemotherapy versus investigator's choice of tyrosine kinase inhibitor (TKI) combined with chemotherapy in subjects with newly-diagnosed Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia (Ph+ ALL).

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 3

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

18 Years

Maximum Age

N/A

Inclusion Criteria:

Newly diagnosed Philadelphia chromosome-positive (Ph+) Acute Lymphoblastic Leukemia (ALL)
Expected survival of at least 3 months
ECOG ≤ 2
Adequate organ function

Exclusion Criteria:

A history of chronic myeloid leukemia (CML)
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 of therapeutic doses of anticoagulants and/or antiplatelet agents; low doses of anticoagulants or antiplatelet agents are allowed
Use a therapeutic drug that has drug interaction with the investigational drug due to other diseases within 7 days or within 5 half-lives (whichever is shorter) prior to the first receipt of the investigational drug
Uncontrolled heart diseases
Any venous thromboembolism in the 6 months prior to randomization, including but not limited to deep vein thrombosis (DVT) or pulmonary embolism
Use of prohibited drugs
Disease or medical condition that is unstable or may affect its safety or compliance with the study
Use of 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
Bleeding disorders unrelated to ALL
Plan to undergo 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 period
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