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

Launched by INSTITUTE OF HEMATOLOGY & BLOOD DISEASES HOSPITAL, CHINA · Sep 28, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of a medication called daratumumab for adults with a condition known as Primary Immune Thrombocytopenia (ITP). ITP is a disorder where the immune system mistakenly attacks and lowers the number of platelets in the blood, which can lead to easy bruising and bleeding. The trial is specifically looking for patients who have not responded well to previous treatments, including corticosteroids and other therapies like rituximab.

To be eligible for this trial, participants need to be at least 18 years old and have been diagnosed with ITP for at least three months. They should have a very low platelet count and have previously tried at least two different treatments without success. During the study, participants will receive daratumumab and will be closely monitored for any side effects or changes in their condition. This trial is currently recruiting participants and aims to provide more options for those struggling with ITP.

Gender

ALL

Eligibility 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 and/or TPO-RA.
• • 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.
• • February 16, 2023 After approval by the Ethics Committee on , subjects no longer require platelet glycoprotein autoantibodies positivity upon enrollment.
• 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.