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

Conditions

• Leukemia, Lymphoblastic, Acute, Philadelphia-Positive
• Ph+ ALL

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Olverembatinib — DRUG
  Oral (PO) once every other day (QOD).
• Investigator's choice of TKI — DRUG
  Oral (PO) once daily (QD).

Study Details

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).

Key Dates

Start date

Aug 31, 2023

Status verified

Apr 2026

Primary completion

Dec 31, 2027

Completion

Jun 30, 2029

Study Design

Enrollment

350 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Olverembatinib
  Olverembatinib in combination with chemotherapy
• Active Comparator: Investigator's choice of TKI
  Investigator's choice of TKI in combination with chemotherapy

Primary Outcome Measure

Minimal Residual Disease Negative CR Rate [ Time Frame: Cycle 1 to Cycle 3 (each cycle is 28 days) ]

Central Contacts

• Ascentage Clinical Operations
  301-291-5658
  [email protected]

Locations (16)

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