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

ConditionsPh+ ALLLeukemia, Lymphoblastic, Acute, Philadelphia-Positive
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAscentage Pharma Group Inc.

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Newly diagnosed Philadelphia chromosome-positive (Ph+) Acute Lymphoblastic Leukemia (ALL)

Expected survival of at least 3 months

ECOG ≤ 2

Adequate organ function

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Olverembatinib

    Drug

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

  • Investigator's choice of TKI

    Drug

    Oral (PO) once daily (QD).

Treatment groups

350 Participants
are divided into 2 treatment groups
Group A: OlverembatinibExperimental treatment 1 intervention
Group B: Investigator's choice of TKIActive comparator 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

Event-free Survival (EFS)

EFS is defined as the time from study randomization to the date of treatment failure (ITF), relapse from CR, or death from any cause, whichever comes first.

Time frame
Baseline up to 3 to 6 years
2

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

According to CTCAE v5.0, the number and frequency of adverse events of test drug will be assessed.

Time frame
Through study completion (approximately 2 years)
3

Plasma concentrations of olverembatinib

Blood samples will be collected to measure the plasma concentration of olverembatinib.

Time frame
Cycle 1 to Cycle 3 (each cycle is 28 days)
4

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

To evaluate health-related Quality of Life (HR-QoL) in patients treated with olverembatinib plus chemotherapy.

Time frame
Through study completion (approximately 2 years)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ascentage Pharma Group Inc.

Lead sponsor

Guangzhou Healthquest Pharma Co., Ltd

Collaborator

Source ClinicalTrials.gov
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