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.
Participant must be 18 years or older.
Primary ITP with platelet cell count of less than 30x10^9/L.
Prior first-line therapy with corticosteroids.
Prior second-line therapy with TPO-RA and/or rituximab and failure to achieve or retain response.
Chronic liver disease. Cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, persistent jaundice. NOTE: Stable non-cirrhotic chronic liver disease (including Gilbert's syndrome or asymptomatic gallstones) is acceptable if participant otherwise meets entry criteria.
To be seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]) at screening or within 3 months prior to first dose of trial treatment.
To be seropositive for hepatitis C at screening or within 3 months prior to first dose of trial treatment.
Established anti-retroviral therapy (ART) for at least 4 weeks and HIV viral load <400 copies/mL
Single group
Belantamab Mafodotin
DrugBelantamab 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
DrugDexamethasone 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.
Clinical efficacy of treatment with belantamab mafodotin in terms of Complete response rate (CRR)/Partial response rate (PRR)
CRR/PRR is defined as the percentage of participants with a confirmed best response of PR or CR (Response-evaluable population). The denominator will be the total number of participants in the Response-evaluable population.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
