This study aims to evaluate the efficacy and safety of Ripertamab in combination with Eltrombopag compared to Eltrombopag alone for patients with Primary Immune Thrombocytopenia (ITP) who have not responded to or have relapsed after first-line steroid therapy. Participants will be randomly assigned to one of two treatment groups and followed for 52 weeks to assess response rates and safety.
Diagnosis: Confirmed Primary Immune Thrombocytopenia (ITP) with an age range of 18 to 80 years, inclusive, and no gender restrictions.
Bone Marrow Cytology: Diagnosis via bone marrow cytology excluding secondary thrombocytopenia caused by other diseases, with primary ITP patients who are unresponsive to or have relapsed after first-line steroid therapy (platelet count drops below 30×10^9/L).
Coagulation Status: Laboratory tests show prothrombin time (PT/INR) and activated partial thromboplastin time (APTT) not exceeding 20% above the upper limit of normal values, with no history of coagulation disorders other than ITP.
Bone Marrow Function: Normal bone marrow function indicated by an absolute neutrophil count (ANC) ≥1.5×10^9/L and hemoglobin (Hb) ≥90 g/L.
Life-Threatening Bleeding: Presence of bleeding that poses an immediate threat to life, such as severe anemia or central nervous system bleeding.
Recent Treatment: Use of intravenous immunoglobulin, thrombopoietin receptor agonists, recombinant human thrombopoietin (rhTPO), immunosuppressants, anti-CD20 monoclonal antibodies, or systemic corticosteroids within 28 days prior to enrollment.
Malignancy History: History of malignancy.
Cardiac Conditions: Presence of severe heart failure or other diseases significantly impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension, arrhythmias, or prolonged QTc interval within the last 3 months).
Parallel
Ripertamab/Eltrombopag
Combination productRipertamab, a novel anti-CD20 monoclonal antibody, in combination with Eltrombopag . Ripertamab is administered intravenously at a dose of 375 mg/m² BSA on Day 1 . If the participant remains in remission at the 3-month mark, an additional intravenous dose of 375 mg/m² Ripertamab is administered. Eltrombopag are given orally at an initial dose of 2.5 mg once daily, with dosage adjustments made every two weeks based on platelet count response, for a total treatment duration of up to Day 28.
Eltrombopag
DrugEltrombopag as a single therapy. Eltrombopag is a thrombopoietin receptor agonist given orally at an initial dose of 2.5 mg once daily, with dosage adjustments made every two weeks based on platelet count response, for a total treatment duration of up to Day 28.
Sustained Response Rate at 12 Weeks
The primary outcome measure is the proportion of patients who achieve a sustained response at 12 weeks after the initiation of treatment. A sustained response is defined as a platelet count of ≥30×10\^9/L without bleeding and without the need for rescue therapy.
Overall Response Rate (ORR)
The percentage of patients who achieve any response (complete or partial) to the treatment as measured by an increase in platelet count from baseline.
Complete Response Rate (CR%)
The proportion of patients who achieve a complete response, defined as a platelet count of ≥100×10\^9/L without bleeding and without the need for rescue therapy.
Median Time to Response (mTTR)
The time at which 50% of the patients achieve a response, measured from the start of treatment until the first evidence of therapeutic effect.
Median Sustained Response Time (mSRT)
The time at which 50% of the patients maintain a response without relapse, measured from the start of treatment until the response is no longer sustained.
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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead sponsor
Sinocelltech Ltd.
Collaborator
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