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

NCT06051409 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: HQP1351AG301
• Study Type: interventional
• Target: 350
• Locations: 12 countries
• Sites: 90

Brief 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

Keywords

Ph+ ALL; Olverembatinib; Acute lymphoblastic leukemia; Bcr-Abl Tyrosine Kinase

Outcome Measures

Primary Outcomes (1)

• Minimal Residual Disease Negative CR Rate

  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.

  Cycle 1 to Cycle 3 (each cycle is 28 days)

Secondary Outcomes (4)

• Event-free Survival (EFS)

  Baseline up to 3 to 6 years

• Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.

  Through study completion (approximately 2 years)

• Plasma concentrations of olverembatinib

  Cycle 1 to Cycle 3 (each cycle is 28 days)

• FACT-Leu (Functional Assessment of Cancer Therapy - Leukemia) Score

  Through study completion (approximately 2 years)

Study Arms (2)

Olverembatinib

EXPERIMENTAL

Olverembatinib in combination with chemotherapy

Drug: Olverembatinib

Investigator's choice of TKI

ACTIVE COMPARATOR

Investigator's choice of TKI in combination with chemotherapy

Drug: Investigator's choice of TKI

Interventions

Olverembatinib DRUG

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

Olverembatinib

Investigator's choice of TKI DRUG

Oral (PO) once daily (QD).

Investigator's choice of TKI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly diagnosed Philadelphia chromosome-positive (Ph+) Acute Lymphoblastic Leukemia (ALL)
• Expected survival of at least 3 months
• ECOG ≤ 2
• Adequate organ function

You may not qualify if:

• A history of chronic myeloid leukemia (CML)
• Clinical manifestations of central nervous system (CNS) leukemia or ALL extramedullary infiltration, except lymphadenopathy or hepatosplenomegaly
• Previous or current clinical CNS diseases
• Autoimmune diseases that may involve the CNS
• Use of therapeutic doses of anticoagulants and/or antiplatelet agents; low doses of anticoagulants or antiplatelet agents are allowed
• Use a therapeutic drug that has drug interaction with the investigational drug due to other diseases within 7 days or within 5 half-lives (whichever is shorter) prior to the first receipt of the investigational drug
• Uncontrolled heart diseases
• Any venous thromboembolism in the 6 months prior to randomization, including but not limited to deep vein thrombosis (DVT) or pulmonary embolism
• Use of prohibited drugs
• Disease or medical condition that is unstable or may affect its safety or compliance with the study
• Use of medications known to cause prolonged QT interval
• Active infections requiring systemic treatment
• Disease that severely affects the oral administration and absorption of drugs, or an active gastrointestinal ulcer
• Contraindications to the use of glucocorticoids
• Bleeding disorders unrelated to ALL

Sponsors & Collaborators

• Guangzhou Healthquest Pharma Co., Ltd: collaborator
• Ascentage Pharma Group Inc.: lead

Study Sites (90)

Ascentage Investigative Site #1044

Birmingham, Alabama, 35233, United States

NOT YET RECRUITING

Ascentage Investigative Site #1062

Duarte, California, 91010, United States

NOT YET RECRUITING

Ascentage Investigative Site #1134

Los Angeles, California, 90048, United States

NOT YET RECRUITING

Ascentage Investigative Site #1059

Los Angeles, California, 90095, United States

NOT YET RECRUITING

Ascentage Investigative Site #1142

Miami, Florida, 33155, United States

NOT YET RECRUITING

Ascentage Investigative Site #1045

Augusta, Georgia, 30912, United States

NOT YET RECRUITING

Ascentage Investigative Site #1158

Indianapolis, Indiana, 46202, United States

NOT YET RECRUITING

Ascentage Investigative Site #1069

Indianapolis, Indiana, 46237, United States

NOT YET RECRUITING

Ascentage Investigative Site #1084

Lexington, Kentucky, 40536, United States

NOT YET RECRUITING

Ascentage Investigative Site #1064

Hackensack, New Jersey, 07601, United States

NOT YET RECRUITING

Ascentage Investigative Site #1098

New Brunswick, New Jersey, 08901, United States

NOT YET RECRUITING

Ascentage Investigative Site #1160

Stony Brook, New York, 11794, United States

NOT YET RECRUITING

Ascentage Investigative Site #1151

The Bronx, New York, 10461, United States

NOT YET RECRUITING

Ascentage Investigative Site #1501

Houston, Texas, 77030, United States

NOT YET RECRUITING

Ascentage Investigative Site #1806

Seattle, Washington, 98104, United States

NOT YET RECRUITING

Ascentage Investigative Site #1155

Morgantown, West Virginia, 26506, United States

NOT YET RECRUITING

Royal North Shore Hospital

St Leonards, New South Wales, Australia

ACTIVE NOT RECRUITING

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

ACTIVE NOT RECRUITING

Alfred Health

Melbourne, Victoria, 3004, Australia

ACTIVE NOT RECRUITING

Royal Perth Hospital

Perth, Washington, 6000, Australia

ACTIVE NOT RECRUITING

The First Affiliated Hospital of Bengbu Medical School

Bengbu, Anhui, 233000, China

NOT YET RECRUITING

Xinqiao Hospital of Army Medical University

Chongqing, Chongqing Municipality, 214426, China

RECRUITING

Guangdong Province People's Hospital

Guangdong, Guangzhou, 510080, China

RECRUITING

Nanfang Hospital of Southern Medical University

Guangdong, Guangzhou, 510515, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, 450003, China

RECRUITING

Wuhan Union Hospital of Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

RECRUITING

The First Affiliated Hospital of Suzhou University

Suzhou, Jiangsu, 215006, China

RECRUITING

Shanghai Jiao Tong University School of Medicine Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

NOT YET RECRUITING

West China Hospital of Sichuan University

Chengdu, Sichuan, 610044, China

RECRUITING

Institute of Blood Transfusion of Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, 215127, China

RECRUITING

Ascentage Investigative Site #8647

Brno, 62500, Czechia

NOT YET RECRUITING

Ascentage Investigative Site #6305

Hradec Králové, 50005, Czechia

NOT YET RECRUITING

Ascentage Investigative Site #6304

Ostrava, 70852, Czechia

NOT YET RECRUITING

Ascentage Investigative Site #6302

Prague, 10034, Czechia

NOT YET RECRUITING

Ascentage Investigative Site #6309

Prague, 12800, Czechia

NOT YET RECRUITING

Ascentage Investigative Site #5020

Le Chesnay, 78150, France

NOT YET RECRUITING

Ascentage Investigative Site #5021

Lyon, 69008, France

NOT YET RECRUITING

Ascentage Investigative Site #5013

Nantes, 44000, France

NOT YET RECRUITING

Ascentage Investigative Site #5025

Nice, 06200, France

NOT YET RECRUITING

Ascentage Investigative Site #5019

Pessac, 33604, France

NOT YET RECRUITING

Ascentage Investigative Site #5024

Pierre-Bénite, 69495, France

NOT YET RECRUITING

Ascentage Investigative Site #5022

Poitiers, 86021, France

NOT YET RECRUITING

Ascentage Investigative Site #5018

Toulouse, 31059, France

NOT YET RECRUITING

Ascentage Investigative Site #5538

Bologna, 40138, Italy

NOT YET RECRUITING

Ascentage Investigative Site #5529

Meldola, 47014, Italy

NOT YET RECRUITING

Ascentage Investigative Site #5539

Milan, 20132, Italy

NOT YET RECRUITING

Ascentage Investigative Site #5533

Monza, 20900, Italy

NOT YET RECRUITING

Ascentage Investigative Site #5540

Ravenna, 48121, Italy

NOT YET RECRUITING

Ascentage Investigative Site #5531

Roma, 00138, Italy

NOT YET RECRUITING

Ascentage Investigative Site #5550

Torino, 10126, Italy

NOT YET RECRUITING

Ascentage Investigative Site #5536

Varese, 21100, Italy

NOT YET RECRUITING

Ascentage Investigative Site #6503

Bucharest, 020125, Romania

NOT YET RECRUITING

Ascentage Investigative Site #6502

Cluj-Napoca, 400015, Romania

NOT YET RECRUITING

Ascentage Investigative Site #6507

Craiova, 200143, Romania

NOT YET RECRUITING

Ascentage Investigative Site #6504

Iași, 700483, Romania

NOT YET RECRUITING

Ascentage Investigative Site #6602

Singapore, 119074, Singapore

NOT YET RECRUITING

Ascentage Investigative Site #6603

Singapore, 169608, Singapore

NOT YET RECRUITING

Ascentage Investigative Site #6604

Singapore, 308433, Singapore

NOT YET RECRUITING

Ascentage Investigative Site #8206

Busan, 49201, South Korea

NOT YET RECRUITING

Ascentage Investigative Site #8207

Busan, 49241, South Korea

NOT YET RECRUITING

Ascentage Investigative Site #8201

Seoul, 03080, South Korea

NOT YET RECRUITING

Ascentage Investigative Site #8202

Seoul, 05505, South Korea

NOT YET RECRUITING

Ascentage Investigative Site #8203

Seoul, 06591, South Korea

NOT YET RECRUITING

Ascentage Investigative Site #8208

Uijeongbu-si, 11759, South Korea

NOT YET RECRUITING

Ascentage Investigative Site #6018

Badalona, 08916, Spain

NOT YET RECRUITING

Ascentage Investigative Site #6019

Badalona, 08916, Spain

NOT YET RECRUITING

Ascentage Investigative Site #6020

Barcelona, 08035, Spain

NOT YET RECRUITING

Ascentage Investigative Site #6048

Cáceres, 10003, Spain

NOT YET RECRUITING

Ascentage Investigative Site #6016

Madrid, 20834, Spain

NOT YET RECRUITING

Ascentage Investigative Site #6049

Madrid, 20840, Spain

NOT YET RECRUITING

Ascentage Investigative Site #6035

Madrid, 28006, Spain

NOT YET RECRUITING

Ascentage Investigative Site #6013

Madrid, 28007, Spain

NOT YET RECRUITING

Ascentage Investigative Site #6011

Madrid, 28041, Spain

NOT YET RECRUITING

Ascentage Investigative Site #6021

Santander, 39008, Spain

NOT YET RECRUITING

Ascentage Investigative Site #6050

Seville, 41010, Spain

NOT YET RECRUITING

Ascentage Investigative Site #6017

Valencia, 6017, Spain

NOT YET RECRUITING

Ascentage Investigative Site #9201

Ankara, 06100, Turkey (Türkiye)

NOT YET RECRUITING

Ascentage Investigative Site #9204

Ankara, 06170, Turkey (Türkiye)

NOT YET RECRUITING

Ascentage Investigative Site #9212

Ankara, 06200, Turkey (Türkiye)

NOT YET RECRUITING

Ascentage Investigative Site #9209

Ankara, 06560, Turkey (Türkiye)

NOT YET RECRUITING

Ascentage Investigative Site #9205

Antalya, 07025, Turkey (Türkiye)

NOT YET RECRUITING

Ascentage Investigative Site #9203

Istanbul, 34381, Turkey (Türkiye)

NOT YET RECRUITING

Ascentage Investigative Site #9202

Izmir, 35100, Turkey (Türkiye)

NOT YET RECRUITING

Ascentage Investigative Site #9211

Kayseri, 38039, Turkey (Türkiye)

NOT YET RECRUITING

Ascentage Investigative Site #9208

Mersin, 33200, Turkey (Türkiye)

NOT YET RECRUITING

Ascentage Investigative Site #9220

Samsun, 55139, Turkey (Türkiye)

NOT YET RECRUITING

Ascentage Investigative Site #9210

Tekirdağ, 59030, Turkey (Türkiye)

NOT YET RECRUITING

Ascentage Investigative Site #7002

Birmingham, B15 2GW, United Kingdom

NOT YET RECRUITING

Ascentage Investigative Site #7034

Glasgow, G12 0YN, United Kingdom

NOT YET RECRUITING

Ascentage Investigative Site #7019

London, SW3 6JJ, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

olverembatinib

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Elias Jabbour, M.D.

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

• Weili Zhao, M.D., Ph.D.

  Shanghai Jiaotong University School of Medicine Ruijin Hospital

  PRINCIPAL INVESTIGATOR

• Suning Chen, M.D., Ph.D.

  First Affiliated Hospital of Suzhou Medical College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ascentage Clinical Operations

CONTACT

301-291-5658; clinical-trials@ascentage.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: September 4, 2023
• First Posted: September 22, 2023
• Study Start: August 31, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2029
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

GB (3); KR (6); IT (8); SG (3); TU (11); US (16); CZ (5); FR (8); ES (12); RO (4); CN (10); AU (4)