Recruiting NCT06051409
A Study of Olverembatinib in Patients With Newly Diagnosed Ph+ ALL (POLARIS-1)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Olverembatinib, Investigator's choice of TKI.
- Who it may be relevant to
- Registry conditions: Ph+ ALL, Leukemia, Lymphoblastic, Acute, Philadelphia-Positive. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, China, Czechia, France +7
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Pivotal Registrational Phase 3 Study of Olverembatinib Combined With Chemotherapy Versus Investigator's Choice of TKI Combined With Chemotherapy in Patients With Newly Diagnosed Ph+ ALL
Overview
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).
Detailed description
Comparing efficacy and safety of olverembatinib in combination with chemotherapy (investigational arm) vs. investigator's choice of TKI in combination with chemotherapy (control arm).
Interventions
- Drug Olverembatinib
Oral (PO) once every other day (QOD). - Drug Investigator's choice of TKI
Oral (PO) once daily (QD).
Primary outcome measures
- Minimal Residual Disease Negative CR Rate [Time frame: Cycle 1 to Cycle 3 (each cycle is 28 days)]
Secondary outcome measures (4)
- Event-free Survival (EFS) [Time frame: Baseline up to 3 to 6 years]
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0. [Time frame: Through study completion (approximately 2 years)]
- Plasma concentrations of olverembatinib [Time frame: Cycle 1 to Cycle 3 (each cycle is 28 days)]
- FACT-Leu (Functional Assessment of Cancer Therapy - Leukemia) Score [Time frame: Through study completion (approximately 2 years)]
Eligibility criteria
Inclusion criteria
- Newly diagnosed Philadelphia chromosome-positive (Ph+) Acute Lymphoblastic Leukemia (ALL)
- Expected survival of at least 3 months
- ECOG ≤ 2
- Adequate organ function
Exclusion criteria
- 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
- Plan to undergo major surgery
- Allergy to drug ingredients, excipients, or their analogues in the study
- Female subjects who are pregnant or breastfeeding or expect to become pregnant during the study period
- Other malignant tumors within 2 years
- Any symptom or illness that may interfere with the evaluation of the efficacy and safety of the investigational drug, or any other condition or condition that is not appropriate for participation in the study
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 16 centers
- Ascentage Investigative Site #1044 — Birmingham
- Ascentage Investigative Site #1062 — Duarte
- Ascentage Investigative Site #1134 — Los Angeles
- Ascentage Investigative Site #1059 — Los Angeles
- Ascentage Investigative Site #1142 — Miami
- Ascentage Investigative Site #1045 — Augusta
- Ascentage Investigative Site #1158 — Indianapolis
- Ascentage Investigative Site #1069 — Indianapolis
- … and 8 more centers
Spain · 12 centers
- Ascentage Investigative Site #6018 — Badalona
- Ascentage Investigative Site #6019 — Badalona
- Ascentage Investigative Site #6020 — Barcelona
- Ascentage Investigative Site #6048 — Cáceres
- Ascentage Investigative Site #6016 — Madrid
- Ascentage Investigative Site #6049 — Madrid
- Ascentage Investigative Site #6035 — Madrid
- Ascentage Investigative Site #6013 — Madrid
- … and 4 more centers
Turkey (Türkiye) · 11 centers
- Ascentage Investigative Site #9201 — Ankara
- Ascentage Investigative Site #9204 — Ankara
- Ascentage Investigative Site #9212 — Ankara
- Ascentage Investigative Site #9209 — Ankara
- … and 7 more centers
China · 10 centers
- The First Affiliated Hospital of Bengbu Medical School — Bengbu
- Xinqiao Hospital of Army Medical University — Chongqing
- Guangdong Province People's Hospital — Guangdong
- Nanfang Hospital of Southern Medical University — Guangdong
- Henan Cancer Hospital — Zhengzhou
- Wuhan Union Hospital of Tongji Medical College of Huazhong University of Science and Techn — Wuhan
- The First Affiliated Hospital of Suzhou University — Suzhou
- Shanghai Jiao Tong University School of Medicine Ruijin Hospital — Shanghai
- … and 2 more centers
France · 8 centers
- Ascentage Investigative Site #5020 — Le Chesnay
- Ascentage Investigative Site #5021 — Lyon
- Ascentage Investigative Site #5013 — Nantes
- Ascentage Investigative Site #5025 — Nice
- Ascentage Investigative Site #5019 — Pessac
- Ascentage Investigative Site #5024 — Pierre-Bénite
- Ascentage Investigative Site #5022 — Poitiers
- Ascentage Investigative Site #5018 — Toulouse
Italy · 8 centers
- Ascentage Investigative Site #5538 — Bologna
- Ascentage Investigative Site #5529 — Meldola
- Ascentage Investigative Site #5539 — Milan
- Ascentage Investigative Site #5533 — Monza
- Ascentage Investigative Site #5540 — Ravenna
- Ascentage Investigative Site #5531 — Roma
- Ascentage Investigative Site #5550 — Torino
- Ascentage Investigative Site #5536 — Varese
South Korea · 6 centers
- Ascentage Investigative Site #8206 — Busan
- Ascentage Investigative Site #8207 — Busan
- Ascentage Investigative Site #8201 — Seoul
- Ascentage Investigative Site #8202 — Seoul
- Ascentage Investigative Site #8203 — Seoul
- Ascentage Investigative Site #8208 — Uijeongbu-si
Czechia · 5 centers
- Ascentage Investigative Site #8647 — Brno
- Ascentage Investigative Site #6305 — Hradec Králové
- Ascentage Investigative Site #6304 — Ostrava
- Ascentage Investigative Site #6302 — Prague
- Ascentage Investigative Site #6309 — Prague
Australia · 4 centers
- Royal North Shore Hospital — St Leonards
- Royal Adelaide Hospital — Adelaide
- Alfred Health — Melbourne
- Royal Perth Hospital — Perth
Romania · 4 centers
- Ascentage Investigative Site #6503 — Bucharest
- Ascentage Investigative Site #6502 — Cluj-Napoca
- Ascentage Investigative Site #6507 — Craiova
- Ascentage Investigative Site #6504 — Iași
Singapore · 3 centers
- Ascentage Investigative Site #6602 — Singapore
- Ascentage Investigative Site #6603 — Singapore
- Ascentage Investigative Site #6604 — Singapore
United Kingdom · 3 centers
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06051409 · HQP1351AG301