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

Sponsor
Hellenic Society of Hematology
Study ID
NCT07019545
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Primary Immune Thrombocytopenia (ITP)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Belantamab Mafodotin — DRUG
    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.
  • Dexamethasone — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jun 20, 2025
Status verified
Jun 2025
Primary completion
Jun 20, 2026
Completion
Jun 20, 2027

Study Design

Enrollment
14 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Single Arm
    Trial treatment is defined as the combination of belantamab mafodotin plus dexamethasone. Trial treatment is given in 28-day cycles for a total period of one year per patient or until treatment failure (loss of response), physician decision, unacceptable toxicity, withdrawal of consent, or death (whichever occurs first). Participants without confirmed response or better after two infusions with belantamab mafodotin, and the interval following the dosing, will be discontinued from trial treatment and will not be replaced.

Primary Outcome Measure

Clinical efficacy of treatment with belantamab mafodotin in terms of Complete response rate (CRR)/Partial response rate (PRR) [ Time Frame: At 6 months of treatment ]

Central Contacts

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