Actively Recruiting
A Single-arm, Open-label Phase II Study of Rituximab Combined With Anti-CD38 Monoclonal Antibody for Primary Immune Thrombocytopenia (ITP)
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2026-01-23
20
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 combining Daratumumab, an anti-CD38 monoclonal antibody, with Rituximab in adults with primary immune thrombocytopenia (ITP) who did not respond to or relapsed after glucocorticoid treatment. ITP is an autoimmune condition causing low platelet counts and bleeding, with current treatments often inadequate for many patients. This phase II, open-label study focuses on patients with relapsed or refractory ITP, aiming to offer new treatment options by targeting both B cells and long-lived plasma cells involved in disease resistance. Participants receive one dose of Rituximab (375 mg/m2) on day 1, followed by eight doses of Daratumumab (16 mg/kg) on days 8, 15, 22, 29, 36, 43, 50, and 57. The combination is intended to reduce harmful antibodies by removing different immune cells. This single-arm trial involves no placebo group and monitors patients over a treatment period to assess response and safety. During the study, participants will be regularly assessed for their platelet counts and bleeding symptoms. The primary outcome is the overall response rate at 12 weeks, with secondary measures including platelet levels, time to reach specific platelet thresholds, bleeding severity, need for rescue treatments, and adverse events monitored over one year. Patients' adherence to treatment and safety will be carefully tracked throughout the trial, which is expected to last until March 2027.
CONDITIONS
Brief Title
Anti-CD38 Monoclonal Antibody Combined With Rituximab in the Management of Primary Immune Thrombocytopenia (ITP)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, male or female
- Diagnosed with primary immune thrombocytopenia for at least three months
- Failed glucocorticoid therapy or relapsed after treatment
- Failed at least one thrombopoietin receptor agonist and rituximab/anti-CD38 therapy, or post-splenectomy relapse
- Platelet count less than 30 x 10^9/L before first study drug dose
- ECOG performance status of 2 or less
- Stable maintenance therapy allowed with one concomitant medication at stable dose for at least 4 weeks
- Negative pregnancy test for fertile females; effective contraception required for fertile females and males during and after study
- Able to understand and follow study protocol and provide informed consent
You will not qualify if you...
- Allergy to CD20 or CD38 monoclonal antibodies
- Diagnosed with 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 prior
- Use of anticoagulants or antiplatelet agents within 3 weeks prior
- Emergency ITP treatment within 2 weeks prior
- Use of certain immunosuppressive or monoclonal antibody drugs within specified recent periods
- Splenectomy within 6 months prior
- Live vaccines within 4 weeks prior or planned during study
- Diagnosis of myelodysplastic syndromes or recent malignancy within 5 years
- History of stem cell or organ transplantation
- Significant medical history posing safety risks including heart, lung, immune, or metabolic diseases
- Recent severe or recurrent infections or immunosuppression
- Specific laboratory abnormalities including elevated liver enzymes, low blood counts, low IgG, or impaired kidney function
- Positive tests for HIV, syphilis, hepatitis B or C
- Pregnant or breastfeeding women, or those planning pregnancy during study
- Other conditions judged 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 - Approximately 8 weeks
Participants receive a single dose of rituximab on day 1 and eight doses of Daratumumab on days 8, 15, 22, 29, 36, 43, 50, and 57 to treat primary immune thrombocytopenia.
9 visits (in-person) including day 1 and days 8 through 57
Duration - Up to 1 year
Participants are monitored for response and safety outcomes for up to 1 year after treatment.
Periodic visits during the 1-year follow-up
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
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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