NCT07019545

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 14 (estimated)
• Sponsor: Hellenic Society of Hematology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Primary Immune Thrombocytopenia (ITP)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-06-20
• Primary completion: 2026-06-20
• Completion: 2027-06-20
• First posted: 2025-06-13
• Last updated: 2025-06-13

Locations

1 site across 1 country: Greece