A Phase 2 Study to Assess the Safety and Efficacy of Subcutaneous Blinatumomab in Combination With Low Intensity Chemotherapy in Older Patients With Newly Diagnosed B-cell Acute Lymphoblastic Leukemia
brief summary
This is a single arm open-label phase 2 trial to study the safety and efficacy of SC Blinatumomab in combination with low-intensity chemotherapy for older or unfit patients with B-ALL.
detailed description
Primary Objective:
a) To evaluate event-free survival (EFS, time from treatment initiation to relapse or death) of SC Blinatumomab in combination with low-intensity chemotherapy in older and unfit patients with newly diagnosed Ph-negative B-cell ALL
Secondary Objectives:
1. Determine efficacy of SC Blinatumomab in combination with low-intensity chemotherapy in older and unfit patients with newly diagnosed Ph-negative B-cell ALL through the overall response rate (complete remission \[CR\] + complete remission with incomplete count recovery \[CRi\]) 2. Determine overall survival (OS, time from treatment start to death from any cause) 3. Determine rates of MRD negativity by flow cytometry (sensitivity of 10-4) and ClonoSeq NGS (sensitivity of 10-6) 4. Determine the safety of the combination of SC Blinatumomab with low intensity chemotherapy
Exploratory Objective:
b) Pending exploratory objectives, single cell analysis and correlation with secondary AML/MDS