RECRUITING Phase 4 ClinicalTrials.gov

Multi-target Drugs Sequential Combination Therapy in Adults Patients With Newly Diagnosed Primary Immune Thrombocytopenia

Sponsor: Institute of Hematology & Blood Diseases Hospital, China • ClinicalTrials.gov ID: NCT07788456

Registry updated: 2026-08-26

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Description

This prospective, single-arm, multicenter, exploratory study will enroll 38 adults patients with newly diagnosed primary immune thrombocytopenia (ITP). Patients will receive standard-dose corticosteroids plus a thrombopoietin receptor agonist (TPO-RA) as initial therapy During the core treatment phase (Weeks 1-12). Corticosteroids will be tapered and discontinued within 8 weeks, whereas TPO-RA treatment will continue for 12 weeks. For patients with treatment failure( defined as platelet count \< 30 × 10\^9/L or less than 2-fold increase of baseline platelet count or bleeding) ,a sequential multitarget combination strategy will be explored in subsequent treatment phases. Specifically, patients with treatment failure after 2 weeks of initial therapy (Weeks 3-12), will receive the ongoing TPO-RA in combination with either rituximab or an anti-CD38 monoclonal antibody（mAb） as sequential combination therapy. During the core treatment follow-up phase (24 weeks), patients with treatment failure will enter the exploratory treatment phase (Weeks 13-36) . Patients who received multi-target drug therapy during the core treatment period will switch to an alternative TPO-RA with cross-administered rituximab and anti-CD38 mAb, while those who did not will receive sequential rituximab or anti-CD38 mAb. Finally, patients will enter the safety follow up period (4 weeks, weeks 37-40).

Interventions

standard-dose methylprednisolone/prednisone. (Drug)
Methylprednisolone 0.8-1mg/kg/day administered intravenously or orally; or prednisone 1 mg/kg/day, up to a maximum dose of 80 mg/day
thrombopoietin receptor agonist(TPO-RA), including but not limited to hetrombopag or eltrombopag. (Drug)
Dosing will follow the recommended dose in the prescribing information; in severe ITP, the initial dose will be selected according to BAT (best available therapy) principles.
rituximab. (Drug)
Administered as 375 mg/m² by intravenous infusion for a single dose, or 100 mg by intravenous infusion once weekly for a total of 4 doses.
Daratumumab (Drug)
Administered at 16 mg/kg by intravenous infusion once weekly for a total of 4-8 doses.

Eligibility criteria

Inclusion Criteria: 1. Age ≥18 years. 2. Confirmed newly diagnosed primary ITP with a platelet count \<30 × 10\^9/L. 3. No prior ITP-related treatment before enrollment, except for standard-dose corticosteroids and/or IVIG for ≤5 days. 4. Able to understand the study and provide signed informed consent.- Exclusion Criteria: 1. Use of corticosteroids or immunosuppressants for a non-ITP condition within 3 months. 2. Contraindication to corticosteroid therapy. 3. Arterial or venous thromboembolic event within 3 months. 4. Pregnant or breastfeeding women. 5. Current treatment with another investigational drug. 6. Any other medical history or condition that, in the investigator's judgment, makes the participant unsuitable for the study. \-

Conditions

ITP - Immune Thrombocytopenia

Locations

Ethics Committee of Hematology Hospital, Chinese Academy of Medical Sciences — Tianjin, China

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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