POLARIS-1
Research type
Research Study
Full title
A Global Multicenter, Open Label, Randomized Phase 3 Registrational Study of Olverembatinib Combined with Chemotherapy Versus Investigator’s Choice of TKI Combined with Chemotherapy in Patients with Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL) (POLARIS-1)
IRAS ID
1011854
Contact name
Yifan Zhai
Contact email
Sponsor organisation
Ascentage Pharma Group Inc.
Eudract number
2024-511496-14
ISRCTN Number
Not applicable
Clinicaltrials.gov Identifier
Research summary
This study is testing a new investigational medicine for Philadelphia Chromosome-Positive Acute Lymphoblastic Leukaemia (Ph+ ALL). The new investigational medicine is called olverembatinib (“Study Drug”), a type of tyrosine kinase inhibitor (TKI). The study drug has not been approved by any regulatory agency for commercial use outside of China.
Standard treatments for this type of leukaemia use drugs TKIs along with chemotherapy and steroid therapy. However, certain genetic changes can make these drugs less effective. The study drug has been developed to work against a wider variety of these genetic changes, specifically targeting mutated (changed) versions of the BCR-ABL gene (which is seen is patients with Ph+ ALL). This means olverembatinib might be a new option for patients with Ph+ ALL.
The aim of this study is to investigate the efficacy of the study drug when used in combination with other anti-cancer medicines. Certain participants of this study will receive a known medication called “investigator’s choice of TKI”. These medications are already approved to treat Ph+ ALL. This falls in the same class of medication as the study drug, a TKI. Investigator’s choice of TKI will also be given in combination with chemotherapy. This medication will be used instead of the study drug, to assess and compare the efficacy and safety between these two drugs. This is called the control arm. Whether participants receive the study drug with chemotherapy or the investigator choice standard TKI is decided at random with two thirds receiving the study drug and one third receiving the standard treatment TKI decided by the study doctor.
Approximately 300 participants with Ph+ ALL will be enrolled in this study which is being conducted at sites around the world. Length of participation depends on how well patients tolerate the study drug or if their cancer doesn’t stabilise or improve.
REC name
Wales REC 3
REC reference
25/WA/0140
Date of REC Opinion
18 Jun 2025
REC opinion
Further Information Favourable Opinion