Combining Teriflunomide and Dexamethasone for Treating Newly Diagnosed Immune Thrombocytopenia

The Combination of Teriflunomide and High-dose Dexamethasone vs High-dose Dexamethasone Alone as First-line Treatment for Newly Diagnosed Adult Primary Immune Thrombocytopenia (ITP): A Prospective, Multicenter, Randomized Trial

This study is testing whether a combination of teriflunomide and high-dose dexamethasone can help adults with newly diagnosed immune thrombocytopenia have better platelet counts and fewer bleeding symptoms compared to just high-dose dexamethasone alone.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 132 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Peking University People's Hospital (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 10 sites (Beijing and 9 other locations)
• Trial ID: NCT06176235 on ClinicalTrials.gov

What this trial studies

This clinical trial is a randomized, open-label, multicenter study that aims to evaluate the efficacy and safety of teriflunomide combined with high-dose dexamethasone compared to high-dose dexamethasone alone in adults with newly diagnosed primary immune thrombocytopenia (ITP). A total of 132 participants will be enrolled and randomized into two groups to receive either the combination treatment or monotherapy. The study will assess platelet counts, bleeding symptoms, and adverse events before and after treatment to determine the effectiveness of the intervention.

Who should consider this trial

Good fit: Ideal candidates for this study are adults who are newly diagnosed with primary immune thrombocytopenia and have a low platelet count.

Not a fit: Patients who have previously received ITP-modifying therapies or have certain infections or malignancies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment approach could provide a more effective first-line therapy for patients with newly diagnosed immune thrombocytopenia.

How similar studies have performed: While the combination of teriflunomide and dexamethasone is a novel approach, similar studies have shown promise in treating immune-related conditions, suggesting potential for success.

Eligibility criteria

Inclusion Criteria:

1. Newly diagnosed, treatment naïve ITP patients
2. Patients with a platelet count \<30,000/μL or a platelet count \<50,000/μL with bleeding manifestations at the enrollment;
3. Willing and able to sign written informed consent.

Exclusion Criteria:

1. Received first-line and second-line ITP-modifying therapy (any previous dose of corticosteroids or other immune-suppressive agents);
2. Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 6 months before the screening visit;
3. Active or a history of malignancy;
4. Positive test result for hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV);
5. Pregnancy or lactation;
6. Pre-existing acute or chronic liver disease, or serum alanine aminotransferase (ALT) greater than 2 times the upper limit of normal (ULN);
7. Current or recent (\<4 weeks before screening) clinically serious viral, bacterial, fungal, or parasitic infection;
8. A known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test;
9. Patients who are deemed unsuitable for the study by the investigator.

Where this trial is running

Beijing and 9 other locations

• Beijing Friendship Hospital — Beijing, China (Recruiting)
• Beijing Hospital — Beijing, China (Recruiting)
• Beijing Luhe Hospital — Beijing, China (Recruiting)
• Beijing Tsinghua Changgeng Hospital — Beijing, China (Recruiting)
• China-Japan Friendship Hospital — Beijing, China (Recruiting)
• Chinese PLA General Hospital — Beijing, China (Recruiting)
• Peking University First Hospital — Beijing, China (Recruiting)
• Peking University Insititute of Hematology, Peking University People's Hospital — Beijing, China (Recruiting)
• Peking University Third Hospital — Beijing, China (Recruiting)
• The Sixth Medical Center of PLA General Hospital — Beijing, China (Recruiting)

Study contacts

• Principal investigator: Xiao-Hui Zhang, MD — Peking University Institute of Hematology, Peking University People's Hospital
• Study coordinator: Xiao-Hui Zhang, MD

Conditions Immune Thrombocytopenia; Teriflunomide; Dexamethasone