Anti-CD38 Antibody Treating Elderly Patients With Primary Immune Thrombocytopenia (ITP)

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age60+
SponsorInstitute of Hematology & Blood Diseases Hospital, China

About this trial

To evaluate the safety and efficacy of Anti-CD38 Antibody in the treatment of elderly patients with primary immune thrombocytopenia in patients who have failed multiple treatment.

Eligibility criteria

Qualifiers

Age ≥60 years, male or female.

Before enrollment, the subjects have been clinically diagnosed with primary immune thrombocytopenia for no less than three months according to the American Society of Hematology guidelines 2011 Evidence-Based Practice Guideline (Neunert et al. 2011) or the International Consensus Report for the Investigation and Management of Primary Immune Thrombocytopenia (Provan et al. 2010), as applicable locally.

Patients have failed glucocorticoid therapy and at least one standard second-line therapy. (either due to inefficacy, efficacy could not be maintained, or relapse). Patients should have a history of response to previous ITP standard first-line therapy (glucocorticoids and/or intravenous human immunoglobulin) (PLT≥50×10^9/L);

Platelet count <30×10^9/L within 24 hours before the first administration of the study drug; During the screening period, platelet counts were measured at least 2 times (at least 1 week apart), with an average platelet count <30×10^9/L and no platelet count > 35×10^9/L.

Disqualifiers

Those who are allergic to anti-CD38 monoclonal antibody or excipients, or who have received anti-CD38 monoclonal antibody in the past and failed or kept a continuous response of less than 6 months.

All kinds of secondary thrombocytopenia or autoimmune hemolytic anemia.

Any history of thrombotic or embolic events or extensive and severe bleeding, such as hemoptysis, massive upper digestive tract hemorrhage, intracranial hemorrhage, etc., or sepsis or other irregular bleeding within 12 months before the first medication.

Participated in or was exposed to any other investigational drug study (including vaccine study) during the 4 weeks or 5 half-lives (whichever is older) prior to the first dose.

Trial design

Treatments tested in this trial

  • Daratumumab Injection

Treatment groups

30 Participants
are divided into 1 treatment group