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
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).
Detailed description
Comparing efficacy and safety of olverembatinib in combination with chemotherapy (investigational arm) vs. investigator's choice of TKI in combination with chemotherapy (control arm).
Arms & interventions
- DrugOlverembatinib
Oral (PO) once every other day (QOD).
- DrugInvestigator's choice of TKI
Oral (PO) once daily (QD).
Outcome measures
Primary
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
Event-free Survival (EFS)
Time frame: Baseline up to 3 to 6 years
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Time frame: Through study completion (approximately 2 years)
Plasma concentrations of olverembatinib
Time frame: Cycle 1 to Cycle 3 (each cycle is 28 days)
FACT-Leu (Functional Assessment of Cancer Therapy - Leukemia) Score
Time frame: Through study completion (approximately 2 years)
Eligibility criteria
Study locations (16)
Ascentage Investigative Site #1044
Birmingham, Alabama, 35233
Ascentage Investigative Site #1062
Duarte, California, 91010
Ascentage Investigative Site #1134
Los Angeles, California, 90048
Ascentage Investigative Site #1059
Los Angeles, California, 90095
Ascentage Investigative Site #1142
Miami, Florida, 33155
Ascentage Investigative Site #1045
Augusta, Georgia, 30912
Ascentage Investigative Site #1158
Indianapolis, Indiana, 46202
Ascentage Investigative Site #1069
Indianapolis, Indiana, 46237
Ascentage Investigative Site #1084
Lexington, Kentucky, 40536
Ascentage Investigative Site #1064
Hackensack, New Jersey, 07601
Ascentage Investigative Site #1098
New Brunswick, New Jersey, 08901
Ascentage Investigative Site #1160
Stony Brook, New York, 11794
Ascentage Investigative Site #1151
The Bronx, New York, 10461
Ascentage Investigative Site #1501
Houston, Texas, 77030
Ascentage Investigative Site #1806
Seattle, Washington, 98104
Ascentage Investigative Site #1155
Morgantown, West Virginia, 26506