NCT04556084

Blinatumomab Bridging Therapy for BALL

Blinatumomab Bridging Therapy in High-Risk B-Acute Lymphoblastic Leukemia: A Phase 2 Study

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Michael Burke · Academic / Other
• Sex: All
• Age: 25 Years
• Healthy volunteers: Not accepted

Summary

The investigator is testing the ability of a biologically active therapy in blinatumomab, an anti-CD19/CD3 bispecific T-cell engager, to further reduce residual leukemia immediately prior to HCT to improve post-HCT outcomes.

Detailed description

The investigator is testing the ability of a biologically active therapy in blinatumomab, an anti-CD19/CD3 bispecific T-cell engager, to further reduce residual leukemia immediately prior to HCT to improve post-HCT outcomes. This Phase 2 study will determine the effectiveness of delivering 1 to 2 cycles of blinatumomab (Days 1-28) as bridging therapy in children, adolescent and young adults with relapse or persistent MRD B-ALL. Eligible subjects will receive 1 or 2, 28-day cycles of blinatumomab prior to proceeding to HCT. Centralized MRD assessment will be performed after completion of the 28-days of blinatumomab using both flow cytometry (University of Washington, Brent Wood, MD) and High-Throughput Deep Sequencing (HTS) MRD technologies (Adaptive Technologies, Seattle, WA). Subjects who achieve flow cytometry negative MRD (\<0.01%) after a single cycle of blinatumomab can proceed directly to HCT whereas subjects who remain MRD positive by flow cytometry may receive a 2nd cycle of blinatumomab. Subjects who remain MRD positive by flow cytometry after a 2nd cycle of blinatumomab will come off study.

Conditions

• B-cell Acute Lymphoblastic Leukemia
• Refractory B Acute Lymphoblastic Leukemia
• Relapsed B-cell Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
DRUG	Blinatumomab	Blinatumomab will be given as a 28-day continuous infusion with 14-days in between Cycle 1 and Cycle 2 as per the package insert and FDA approved labeling. Patient weight greater than or equal to 45kg will receive 28 mcg/day Patient weight less than 45kg will receive 15 mcg/m2/day

Timeline

• Start date: 2021-01-01
• Primary completion: 2022-10-01
• Completion: 2022-10-01
• First posted: 2020-09-21
• Last updated: 2025-05-13
• Results posted: 2025-05-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study