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

Recruiting Phase 3 Interventional Study
Ph+ ALL Leukemia, Lymphoblastic, Acute, Philadelphia-Positive
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
350 (estimated)
Sponsor
Ascentage Pharma Group Inc. · Industry
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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).

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Newly diagnosed Philadelphia chromosome-positive (Ph+) Acute Lymphoblastic Leukemia (ALL) 2. Expected survival of at least 3 months 3. ECOG ≤ 2 4. Adequate organ function Exclusion Criteria: 1. A history of chronic myeloid leukemia (CML) 2. Clinical manifestations of centra…
Contacts

Ascentage Clinical Operations

301-291-5658

clinical-trials@ascentage.com

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