NCT07153796

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• B-cell Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
DRUG	Blinatumomab	Given by IV
DRUG	Mini-CVD	Given by IV
DRUG	MTX/ARA-C	Given by IV

Timeline

• Start date: 2026-01-30
• Primary completion: 2031-09-30
• Completion: 2033-09-30
• First posted: 2025-09-04
• Last updated: 2026-02-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study