CI

At a glance

ClinicalIndex Comparison Record
Phase 3Recruiting· 350 target
Drug / intervention
Olverembatinib +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06051409
NCT06051409Phase 3RecruitingOn TrackUpdated 2mo ago
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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

Ascentage Pharma Group Inc.·interventional·Posted Sep 22, 2023·Updated Apr 30, 2026

In Brief

A Phase 3 clinical trial evaluating Olverembatinib and Investigator's choice of TKI for Ph+ ALL and Leukemia, Lymphoblastic, Acute, Philadelphia-Positive. Currently recruiting, targeting 350 participants across 90 sites in 12 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPh+ ALL, Leukemia, Lymphoblastic, Acute, Philadelphia-Positive
CountriesAustralia, China, Czechia, France, Italy, Romania, Singapore, South Korea, Spain, Turkey (Türkiye), United Kingdom, United States
CollaboratorsGuangzhou Healthquest Pharma Co., Ltd

Timeline

Phase 3Recruiting
202420252026202720282029
First PostedSep 22, 2023
Enrollment StartAug 31, 2023
Primary CompletionDec 31, 2027
Study CompletionJun 30, 2029
TodayJul 1, 2026
Enrollment to primary: 4.3 yearsPosted 2.8 years agoPrimary completion in 1.5 years

Interventions

Olverembatinibdrug

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

Investigator's choice of TKIdrug

Oral (PO) once daily (QD).