Study of Olverembatinib for Newly Diagnosed Ph+ ALL

This study is testing a drug called olverembatinib for people with newly diagnosed Philadelphia chromosome-positive Acute Lymphoblastic Leukemia (Ph+ ALL), a type of fast-growing blood cancer. Researchers want to see how well olverembatinib, when given with chemotherapy, works compared to another standard treatment (investigator's choice of TKI, also with chemotherapy). Both olverembatinib and the other TKI are kinase inhibitors, meaning they block certain proteins that help cancer cells grow. The main goal is to see if the cancer disappears completely and stays gone (Minimal Residual Disease Negative CR Rate) after 1 to 3 cycles of treatment. You might be able to join if you are at least 18 years old, have newly diagnosed Ph+ ALL, and are generally healthy enough for treatment. The study plans to enroll 350 participants.

Study design
This is a global, multi-center, open-label (you and your doctors will know which treatment you are receiving), randomized Phase 3 study comparing two treatment approaches in 350 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured from Cycle 1 to Cycle 3 (each cycle is 28 days), but the overall follow-up duration is not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06051409

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
Ascentage Pharma Group Inc.
~350 participants
Updated 2026-04-30 on ClinicalTrials.gov
What's tested:OlverembatinibInvestigator's choice of TKI

At a glance

Recruiting sites
8 of 90 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Minimal Residual Disease Negative CR Rate
Measured over Cycle 1 to Cycle 3 (each cycle is 28 days)
Ph+ ALL
Leukemia, Lymphoblastic, Acute, Philadelphia-Positive
90 sites across 32 states
Spain12
Turkey (Türkiye)11
France8
Italy8
South Korea6
Czechia5
Romania4
California3
  • Elias Jabbour, M.D. · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center
  • Weili Zhao, M.D., Ph.D. · PRINCIPAL_INVESTIGATOR · Shanghai Jiaotong University School of Medicine Ruijin Hospital
  • Suning Chen, M.D., Ph.D. · PRINCIPAL_INVESTIGATOR · First Affiliated Hospital of Suzhou Medical College

Opens a ready-to-send draft in your own email app — review before sending.

  • Minimal Residual Disease Negative CR RateCycle 1 to Cycle 3 (each cycle is 28 days)

    The minimal residual disease negative CR rate of olverembatinib combined with chemotherapy versus investigator's choice of TKI combined with chemotherapy in subjects with newly diagnosed Ph+ALL.