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

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

14

Participants

Timeline

Start Date

June 20, 2025

Primary Completion Date

June 20, 2026

Study Completion Date

June 20, 2027

Conditions
Primary Immune Thrombocytopenia (ITP)
Interventions
DRUG

Belantamab Mafodotin

Belantamab mafodotin is administered intravenously (IV) at a dose of 1.9 mg/kg on Day 1 of every other 28-day cycle for the first two administrations and then 1.9 mg/kg on Day 1 of every third 28-day cycle.

DRUG

Dexamethasone

Dexamethasone is administered IV or per OS (PO) at a dose of 40 mg/day on days 1, 2, 3, 4 and 15, 16, 17, 18 of every 28-day cycle for the first two cycles in participants \<75 years; at 20 mg/day on days 1, 2, 3, 4 and 15, 16, 17, 18 of every 28-day cycle for the first two cycles in participants ≥75 years.

Trial Locations (1)

11528

"General Hospital of Athens Alexandra, Athens, Attica", Athens

All Listed Sponsors
lead

Hellenic Society of Hematology

OTHER