Actively Recruiting
A Single-arm, Open-label Clinical Study Evaluating the Safety and Efficacy of Daratumumab in Elderly Patients With Primary Immune Thrombocytopenia
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-07-14
30
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 an Anti-CD38 antibody called Daratumumab in treating elderly patients aged 60 and above who have primary immune thrombocytopenia (ITP) and have not responded well to multiple treatments. ITP is an autoimmune disease causing low platelet counts, leading to bleeding issues, and it is especially challenging to treat in older adults who may not tolerate standard therapies well. This Phase 2, single-arm, open-label study aims to address these treatment challenges by targeting long-lived plasma cells believed to contribute to the disease's persistence. The study involves 30 elderly participants receiving Daratumumab infusions once a week at a dose of 16 mg/kg over four weeks. This initial treatment period is followed by a 20-week observation phase without treatment to monitor ongoing safety and effectiveness. Daratumumab works by targeting CD38 on plasma cells, aiming to reduce the abnormal antibodies that cause platelet destruction in ITP. The trial evaluates both immediate and longer-term responses to this therapy. Participants will undergo regular monitoring including platelet counts measured multiple times before treatment and throughout the 24-week study. Safety is closely observed, tracking adverse events and bleeding episodes. Researchers will assess treatment effectiveness within 8 weeks and at intervals up to 24 weeks, including remission rates and the need for emergency treatments. The study also monitors the reduction of other ITP medications and overall patient health during and after treatment.
CONDITIONS
Brief Title
Anti-CD38 Antibody Treating Elderly Patients With Primary Immune Thrombocytopenia (ITP)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 60 years or older, male or female.
- Diagnosed with primary immune thrombocytopenia for at least three months according to established guidelines.
- Failed glucocorticoid therapy and at least one standard second-line treatment.
- Platelet count below 30 x 10^9/L measured at least twice during screening.
- ECOG performance status score of 2 or less.
- Allowed to receive one stable maintenance therapy such as low-dose glucocorticoids or TPO receptor agonists.
- Negative pregnancy test for fertile females; effective contraception required during and after the study.
- Understands and agrees to follow study procedures and signed informed consent.
You will not qualify if you...
- Allergy to anti-CD38 antibody or prior treatment failure with anti-CD38 therapy.
- Secondary thrombocytopenia or autoimmune hemolytic anemia.
- History of serious thrombotic or bleeding events, sepsis, or irregular bleeding within 12 months.
- Participation in other investigational drug studies within 4 weeks or 5 half-lives before dosing.
- Use of antiplatelet drugs within 3 weeks before dosing.
- Emergency treatment for ITP within 2 weeks before dosing.
- Recent treatment with certain immunosuppressive drugs within specified time frames.
- Splenectomy within 6 months before dosing.
- Recent or planned live vaccinations during the study.
- Diagnosis of myelodysplastic syndromes or recent malignancy (with some exceptions).
- History of stem cell or organ transplantation.
- Significant medical conditions posing safety risks as judged by investigators.
- Recent severe infections or immunosuppression.
- Abnormal laboratory values exceeding specific thresholds.
- Positive tests for HIV, syphilis, hepatitis B or C with active infection.
- Pregnant or breastfeeding women or partners intending pregnancy during the study.
- Any other condition deemed unsuitable by the investigator.
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 - 4 weeks
Participants receive intravenous infusion of Daratumumab 16mg/kg once a week for 4 weeks to observe safety and efficacy during treatment.
4 weekly visits (in-person)
Duration - 20 weeks
Participants are observed for safety and continuous efficacy of Daratumumab after treatment ends.
Visits during weeks 5 to 24 (schedule may vary)
Trial Site Locations
Total: 1 location
1
Chinese Academy of Medical Science and Blood Disease Hospital
Tianjin, Tianjin Municipality, China, 301600
Actively Recruiting
Research Team
T
Ting Sun, 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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