A Randomized, Open-label Study To Compare The Efficacy And Safety Of Anti-CD38 Monoclonal Antibody Versus Rituximab in ITP Patients Who Failed or Relapsed After Glucocorticoid Therapy

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This randomized, open-label study aim to compare the efficacy and safety of Daratumumab (anti-CD38 monoclonal antibody) with rituximab in ITP patients.This study will be conducted in ITP patients who had not responded to or had relapsed after previous glucocorticoid treatment.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥18 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 (either due to inefficacy, efficacy could not be maintained, or relapse). Patients were required to have a response history (PLT≥50×10\^9/L) to standard first-line treatment of ITP (glucocorticoid and/or intravenous immunoglobulin).

• Subjects with a platelet count of \<30×10\^9/L within the 24 hours prior to the first dose of the study drug; The mean platelet count of at least two separate assessments (at least 1 week apart) \<30×10\^9/L during the screening visit, and no platelet count \> 35×10\^9/L.

• ECOG performance status score of ≤2.

• Enrollment of subjects receiving maintenance therapy with a stable dosage is permitted, including glucocorticoids (≤0.5 mg/kg of prednisone or equivalent) or TPO receptor agonists. However, at the time of enrollment, subjects are restricted to using only one concomitant medication with a stable dose, and the concomitant medication must have been stable for a minimum of 4 weeks prior to the initial infusion of the study drug.

• For fertile female patients, a negative pregnancy test result is required. Fertile female and male patients must use effective contraception separately during the study and for 4 or 6 months after the cessation of study drug treatment.

• Subjects comprehensively understand and can adhere to the study protocol requirements and willingly signed the informed consent form.

Locations
Other Locations
China
Chinese Academy of Medical Science and Blood Disease Hospital
RECRUITING
Tianjin
Contact Information
Primary
Lei Zhang, MD
zhanglei1@ihcams.ac.cn
+8613502118379
Backup
Yunfei Chen, MD
chenyunfei@ihcams.ac.cn
+8618502220788
Time Frame
Start Date: 2026-01-20
Estimated Completion Date: 2027-11
Participants
Target number of participants: 160
Treatments
Active_comparator: rituximab
Rituximab (375mg/m2) was given once.
Experimental: Daratumumab(Anti-CD38 Monoclonal Antibody )
Daratumumab(anti-CD38 monoclonal antibody )(16mg/kg) was given once a week for eight times
Sponsors
Leads: Institute of Hematology & Blood Diseases Hospital, China

This content was sourced from clinicaltrials.gov

Similar Clinical Trials