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

This is a Phase II open label, prospective, multicenter trial designed to assess the safety and clinical activity of belantamab mafodotin in adult patients with primary immune thrombocytopenia (ITP) previously treated with a thrombopoietin receptor agonist (TPO-RA) and/or rituximab after first-line treatment with corticosteroids. Overall, 14 participants will be enrolled in the trial. Participants' follow-up will continue for up to 12 months after the last participant is enrolled. The accrual period will be approximately 12 months. Trial treatment will be given in 28-day cycles for a total period of one year per patient or until treatment failure, physician decision, unacceptable toxicity, withdrawal of consent, or death (whichever occurs first). Participants without confirmed Response (R) or better after two infusions with belantamab mafodotin will be discontinued from trial treatment and will not be replaced.

NCT Number	NCT07019545
Lead Sponsor	Hellenic Society of Hematology
Conditions	Primary Immune Thrombocytopenia (ITP)
Enrollment	14 participants
Start Date	2025-06-20
Primary Completion	2026-06-20 (estimated)
Study Completion	2027-06-20 (estimated)
Updated on ClinicalTrials.gov	2025-06-13