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A phase II trial aiming to investigate the safety and clinical activity of belantamab mafodotin in adult patients with primary immune thrombocytopenia previously treated with a thrombopoietin receptor agonist and/or rituximab after corticosteroid first-line therapy - BONSAI

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-509131-12-01
Acronym
EAE140
Enrollment
14
Registered
2025-02-11
Start date
2025-09-30
Completion date
Unknown
Last updated
2025-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Immune Thrombocytopenia

Brief summary

Complete response rate (CRR)/Partial response rate (PRR) at 6 months of treatment.

Detailed description

Patients with treatment-emergent adverse events (AEs) and serious AEs., Overall response rate at 2, 6 and 12 months., Complete response rate at 12 months., Time to response (TTR), Duration of response (DoR)., ORR., Number of participants with abnormal ocular findings (on ophthalmic exam)., Belantamab mafodotin dose holds., Number and proportion of participants with changes from baseline in ocular symptoms and related impacts as measured by the Vision Related Anamnestic Tool

Interventions

None listed

Sponsors

Hellenic Society Of Hematology
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Complete response rate (CRR)/Partial response rate (PRR) at 6 months of treatment.

Secondary

MeasureTime frame
Patients with treatment-emergent adverse events (AEs) and serious AEs., Overall response rate at 2, 6 and 12 months., Complete response rate at 12 months., Time to response (TTR), Duration of response (DoR)., ORR., Number of participants with abnormal ocular findings (on ophthalmic exam)., Belantamab mafodotin dose holds., Number and proportion of participants with changes from baseline in ocular symptoms and related impacts as measured by the Vision Related Anamnestic Tool

Countries

Greece

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026