A Study of Olverembatinib in Patients With Newly Diagnosed Ph+ALL.

Ph+ ALL Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

Comparing efficacy and safety of Olverembatinib in combination with chemotherapy (investigational arm) vs. Imatinib in combination with chemotherapy (control arm). ;

Study Design

Related Conditions & MeSH terms

Ph+ ALL

Clinical Trial Details

NCT number	NCT06051409
Study type	Interventional
Source	Ascentage Pharma Group Inc.
Contact	Yifan Zhai, M.D., Ph.D.
Phone	+86-20-28069260
Email	yzhai@ascentage.com
Status	Recruiting
Phase	Phase 3
Start date	August 31, 2023
Completion date	October 31, 2028

View Details

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT05603156` - A Study of Olverembatinib Combined With Inotuzumab Ozogamicin in the Treatment ph+ ALL With MRD Persistent Positive	N/A
Terminated	`NCT01028716` - Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies	Phase 2
Completed	`NCT03678454` - Iclusig® (Ponatinib) in Clinical Practice for the Treatment of Chronic Myeloid Leukemia or Ph+ Acute Lymphoblastic Leukemia in Belgium
Suspended	`NCT04554459` - Ponatinib Plus Reduced-intensity Chemotherapy in the First-line Treatment of Adult Patients With Ph+ ALL	Phase 2