Phase 3 Randomized, Controlled Study of Blinatumomab Alternating With Low-intensity Chemotherapy Versus Standard of Care for Older Adults With Newly Diagnosed Philadelphia-negative B-cell Precursor Acute Lymphoblastic Leukemia With Safety Run-in (Golden Gate Study)
Amgen
Summary
The safety run-in part of the study aims to evaluate the safety and tolerability of blinatumomab alternating with low-intensity chemotherapy. The phase 3 part of the study aims to compare event-free survival (EFS) and overall survival (OS) of participants receiving blinatumomab alternating with low-intensity chemotherapy to EFS and (OS) of participants receiving standard of care (SOC) chemotherapy.
Eligibility
- Age range
- 40–100 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: \- Age ≥ 55 years at the time of informed consent. OR Age 40 to \< 55 years of age if at least 1 of the following comorbidities at the time of informed consent: * history of grades 3 and 4 pancreatitis * diabetes mellitus with end-organ damage * severe liver disease such as cirrhosis stage 2 with portal hypertension or history of esophageal variceal bleeding and aspartate transaminase (AST)/alanine aminotransferase (ALT) \> 10 x upper limit of normal (ULN) (liver cirrhosis must be confirmed by biopsy) * body mass index (BMI) ≥ 40 combined with relevant comorbidities such…
Interventions
- DrugBlinatumomab
Continuous intravenous (cIV) infusion
- DrugLow-intensity chemotherapy regimen
Intravenous (IV), oral (PO), subcutaneous (SC), or intrathecal (IT) administration.
- DrugSOC chemotherapy regimen
Intravenous (IV), oral (PO), subcutaneous (SC), or intrathecal (IT) administration.
Locations (192)
- City of Hope National Medical CenterDuarte, California
- University of California IrvineOrange, California
- University of California San FranciscoSan Francisco, California
- Adventist Health System/Sunbelt, Inc d/b/a AdventHealth OrlandoOrlando, Florida
- Cleveland Clinic FoundationCleveland, Ohio
- Saint Francis Hospital, IncGreenville, South Carolina