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

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