NCT03367299

Sequential Chemotherapy and Blinatumomab to Improve MRD Response and Survival in Acute Lymphoblastic Leukemia

National Treatment Program With Sequential Chemotherapy and Blinatumomab to Improve Minimal Residual Disease Response and Survival in Philadelphia Chromosome-Negative B-Cell Precursor Adult Acute Lymphoblastic Leukemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 149 (actual)
• Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The present study aims at analyzing the response to treatment of adult patients homogeneously treated with supportive care, chemotherapy and blinatumomab.

Detailed description

Eligible patients with CD19+ Ph- BCP ALL (Philadelphia-negative B-cell precursor acute lymphoblastic leukemia) will receive homogeneous supportive care, chemotherapy and blinatumomab immunotherapy, and will be homogeneously analyzed for response at prefixed time points from induction day 1. For risk-oriented therapy, patients in complete remission (CR) will be stratified by risk class according to the diagnostic characteristics and MRD (minimal residual disease) study results during early consolidation.

Conditions

• Acute Lymphoid Leukemia
• Philadelphia Chromosome-Negative B-Cell Precursor

Interventions

Type	Name	Description
DRUG	Chemotherapy + Blinatumomab	Chemotherapy cycles are administered at 21-28 days intervals and each blinatumomab course is 28-day long.

Timeline

• Start date: 2018-06-08
• Primary completion: 2024-09-02
• Completion: 2024-09-02
• First posted: 2017-12-08
• Last updated: 2025-01-22

Locations

62 sites across 1 country: Italy

Regulatory

• FDA-regulated drug study