Trials / Recruiting
RecruitingNCT06051409
A Study of Olverembatinib in Patients With Newly Diagnosed Ph+ALL.
A Pivotal Registrational Phase 3 Study of Olverembatinib Combined With Chemotherapy Versus Imatinib Combined With Chemotherapy in Patients With Newly Diagnosed Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia (Ph+ALL)
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 350 (estimated)
- Sponsor
- Ascentage Pharma Group Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
A global multicenter, open-label, randomized and registrational Phase 3 study to evaluate efficacy and safety of Olverembatinib combined with chemotherapy versus Imatinib combined with chemotherapy in subjects with newly diagnosed Ph+ALL.
Detailed description
Comparing efficacy and safety of Olverembatinib in combination with chemotherapy (investigational arm) vs. Imatinib in combination with chemotherapy (control arm).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Olverembatinib | Orally, once every other day (QOD). |
| DRUG | Imatinib | Orally, once daily (QD). |
Timeline
- Start date
- 2023-08-31
- Primary completion
- 2024-12-31
- Completion
- 2028-10-31
- First posted
- 2023-09-22
- Last updated
- 2024-11-07
Locations
14 sites across 2 countries: Australia, China
Source: ClinicalTrials.gov record NCT06051409. Inclusion in this directory is not an endorsement.