Actively Recruiting
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
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2026-02-11
160
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of Daratumumab, an anti-CD38 monoclonal antibody, compared to rituximab in adults with primary immune thrombocytopenia (ITP) who have not responded to or relapsed after glucocorticoid treatment. ITP is an autoimmune disorder that causes low platelet counts leading to bleeding issues, and current treatments often have limited success, especially in recurrent or resistant cases. Participants will be randomly assigned to receive either rituximab once at a dose of 375 mg/m2 or Daratumumab once weekly for eight weeks at 16 mg/kg. This study is open-label and includes a Phase 2 design to assess and compare these treatments in patients who have previously failed glucocorticoid therapies. During the study, participants will undergo regular assessments including platelet counts, bleeding evaluations, and monitoring for adverse events at multiple timepoints up to 12 months. The primary outcome is the overall response rate at 12 weeks. Secondary outcomes include complete and partial response rates, platelet count thresholds, duration to response, emergency treatments, use of maintenance drugs, bleeding scale changes, and safety evaluations. The study will last up to one year following treatment initiation to closely monitor treatment effects and safety.
CONDITIONS
Brief Title
Anti-CD38 Monoclonal Antibody Versus Rituximab in the Management of Primary Immune Thrombocytopenia (ITP)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any gender
- Diagnosed with primary immune thrombocytopenia for at least three months as per established guidelines
- Failed glucocorticoid therapy or relapsed after glucocorticoid treatment
- Platelet count below 30 x 10^9/L at screening and before first study drug dose
- ECOG performance status score of 2 or less
- On stable maintenance therapy with only one medication such as glucocorticoids or TPO receptor agonists for at least 4 weeks
- Negative pregnancy test for fertile females and use of effective contraception for fertile males and females during and after study
- Ability to understand and comply with study requirements and provide informed consent
You will not qualify if you...
- Prior treatment with CD20 or CD38 monoclonal antibodies
- Diagnosed autoimmune hemolytic anemia or secondary thrombocytopenic disorders
- History of serious thrombotic or bleeding events within 12 months before study
- Participation in other investigational drug studies within 4 weeks or 5 half-lives before study
- Use of anticoagulants or antiplatelet agents within 3 weeks before study
- Emergency treatments for ITP within 2 weeks before study
- Use of certain immunosuppressive medications within 4 to 6 months before study
- Splenectomy within 6 months before study
- Receipt of live vaccines within 4 weeks before or planned during study
- Diagnosis of myelodysplastic syndromes or recent malignancy
- History of organ or stem cell transplantation
- Significant medical conditions affecting safety or study results
- Recent severe or chronic infections or immunosuppression
- Abnormal laboratory values beyond set thresholds
- Positive tests for HIV, syphilis, hepatitis B or C infections
- Pregnant or breastfeeding women and male partners intending pregnancy
- Any other conditions deemed unsuitable by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants receive either rituximab as a single dose or daratumumab once weekly for eight weeks to manage immune thrombocytopenia.
1 visit for rituximab or weekly visits for daratumumab for 8 weeks
Duration - Up to 12 months
Participants are monitored to assess treatment response and safety for up to 12 months after treatment.
Visits at multiple timepoints up to 12 months
Trial Site Locations
Total: 1 location
1
Chinese Academy of Medical Science and Blood Disease Hospital
Tianjin, Tianjin Municipality, China, 300020
Actively Recruiting
Research Team
L
Lei Zhang, MD
Y
Yunfei Chen, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here