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NCT06051409 · ClinicalTrials.gov registry record · Phase 3
A Study of Olverembatinib in Patients With Newly Diagnosed Ph+ ALL (POLARIS-1)
A Phase 3 study, sponsored by Ascentage Pharma Group.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 350
- Enrollment target
NCT06051409: Recruiting Phase 3 study, sponsored by Ascentage Pharma Group.
NCT06051409 is a Phase 3 study that is actively recruiting participants, run by Ascentage Pharma Group. The registered enrollment target is 350 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06051409, a Phase 3 study, is actively recruiting participants, sponsored by Ascentage Pharma Group.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 350 participants
- Enrollment target
Study 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).
Primary Outcome
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.
Interventions
- DRUG Olverembatinib
- DRUG Investigator's choice of TKI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 350 participants |
| Start Date | 2023-08-31 |
| Est. Completion | 2029-06-30 |
| Phase | Phase 3 |
What NCT06051409 shows while recruiting
NCT06051409 is an interventional study that assigns participants to a tested intervention. The registered 350 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 2 interventions - of which Olverembatinib is the first listed.
NCT06051409 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06051409 about?
NCT06051409 is a clinical study titled "A Study of Olverembatinib in Patients With Newly Diagnosed Ph+ ALL (POLARIS-1)". 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 Chromoso...
What is the current status of trial NCT06051409?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 350 participants. The study started on 2023-08-31. Estimated completion is 2029-06-30.
What interventions are being tested in trial NCT06051409?
The interventions under investigation include: Olverembatinib (DRUG), Investigator's choice of TKI (DRUG).
Who is sponsoring clinical trial NCT06051409?
This trial is sponsored by Ascentage Pharma Group, which has 15 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06051409's enrollment target sits among peer trials
350 1034th of 2000 higher than 956 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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