NCT03480438

Treatment of Older Patients With B-precursor ALL With Sequential Dose Reduced Chemotherapy and Blinatumomab

Phase II Trial for the Treatment of Older Patients With Newly Diagnosed CD19 Positive, Ph/BCR-ABL Negative B-precursor Acute Lymphoblastic Leukemia With Sequential Dose Reduced Chemotherapy and Blinatumomab (EWALL-BOLD)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Goethe University · Academic / Other
• Sex: All
• Age: 56 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

The trial proposed here attempts to reduce induction chemotherapy to phase I of standard induction in patients with B-precursor ALL. Induction phase II will be replaced by blinatumomab. The initial treatment phase is followed by sequential chemotherapy and further blinatumomab cycles.

Detailed description

Blinatumomab is a bispecific single-chain antibody construct designed to link B cells and T cells resulting in T-cell activation and a cytotoxic T-cell response against CD19 expressing cells. In Phase II-III clinical trials 43-69 % of the patients treated with blinatumomab in relapsed/refractory ALL with poor prognostic features, achieved a complete hematologic remission and around 80 % of these obtained a molecular remission as well. Blinatumomab thus has demonstrated significant antileukemic activity in relapsed/refractory adult ALL. The ultimate goal for optimised management of adult ALL is to integrate targeted compounds with known single-drug activity into first-line treatment.

Conditions

• B-Precursor ALL

Interventions

Type	Name	Description
DRUG	Blinatumomab	Patients will receive standard of care chemotherapy before blinatumomab, between blinatumomab cycles and after blinatumomab.

Timeline

• Start date: 2018-06-01
• Primary completion: 2024-01-10
• Completion: 2024-01-10
• First posted: 2018-03-29
• Last updated: 2025-10-03

Locations

21 sites across 1 country: Germany