A Study of Olverembatinib in Patients With Newly Diagnosed Ph+ ALL (POLARIS-1)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAscentage Pharma Group Inc.
About this trial
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).
Eligibility criteria
Qualifiers
Newly diagnosed Philadelphia chromosome-positive (Ph+) Acute Lymphoblastic Leukemia (ALL)
Expected survival of at least 3 months
ECOG ≤ 2
Adequate organ function
Disqualifiers
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
Trial design
Treatments tested in this trial
- Olverembatinib
- Investigator's choice of TKI
Treatment groups
350 Participants
are divided into 2 treatment groupsSponsors and collaborators
Ascentage Pharma Group Inc.
Lead sponsor
Guangzhou Healthquest Pharma Co., Ltd
Collaborator
Source ClinicalTrials.gov