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

NCT06051409 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2026-04-30

No results posted yet for this study

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).

Conditions

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

Interventions

DRUG

Olverembatinib

Oral (PO) once every other day (QOD).

DRUG

Investigator's choice of TKI

Oral (PO) once daily (QD).

Sponsors & Collaborators

  • Guangzhou Healthquest Pharma Co., Ltd

    collaborator UNKNOWN

  • Ascentage Pharma Group Inc.

    lead INDUSTRY

Principal Investigators

  • Elias Jabbour, M.D. · M.D. Anderson Cancer Center

  • Weili Zhao, M.D., Ph.D. · Shanghai Jiaotong University School of Medicine Ruijin Hospital

  • Suning Chen, M.D., Ph.D. · First Affiliated Hospital of Suzhou Medical College

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-31
Primary Completion
2027-12-31
Completion
2029-06-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • China
  • Czechia
  • France
  • Italy
  • Romania
  • Singapore
  • South Korea
  • Spain
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06051409 on ClinicalTrials.gov