A Clinical Trial to Assess Safety and Efficacy of Daratumumab in the Treatment of Primary Immune Thrombocytopenia

• Status: Not yet recruiting
• Trial end date: 2024-05-31
• Target enrollment: 0
• Participant gender: All

Summary

A single-center, open-label, off-label use investigator-initiated clinical study with safety run-in to explore the clinical activity and safety of daratumumab in adult ITP patients who have not responded adequately or relapsed after first-line treatment and at least one second-line therapy including rituximab and/or TPO-RA.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Hematology & Blood Diseases Hospital
• Treatments: Daratumumab

Criteria

Inclusion Criteria:

• Male or female aged ≥18 years.

• Diagnosed with ITP that has persisted for ≥3 months and with a platelet count of <30 X 109/L measured within 2 days prior to inclusion.

• Failure to achieve response or relapse after corticosteroid therapy, and at least one second-line therapy including rituximab.

• If receiving emergency care for ITP, treatment should be stopped >2 weeks before first dose.

• A positive result to the ELISA test to detect antibody against GPIIb/IIIa or GPIIb/IIIa and GPIb/IX within 1 week prior to inclusion.

• With normal hepatic and renal functions.

• ECOG Performance Status ≤ 2.

Exclusion Criteria:

• Received any treatment of anti-CD38 antibody drug.

• Has been diagnosed with malignancy and/or liver failure, heart failure and renal failure.

• Known previous infection or seropositivity for HIV, Hepatitis B, Hepatitis C, Cytomegalovirus, EB virus, Syphilis.

• Any clinically overt hemorrhage.

• Has been diagnosed with cardiac disease, arrhythmia and/or severe or uncontrollable hypertension

• Known pulmonary embolism, thrombosis and/or atherosclerosis.

• Has been received allogeneic stem cell transplantation or organ transplantation.

• Patients with history of current or past psychiatric disease that might interfere with the ability to comply with the study protocol or give informed consent.

• Pregnancy or lactation.