Eltrombopag with rituximab versus eltrombopag alone for adults with ITP

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, randomized, open‑label Phase 4 trial in China enrolled 224 adults with previously treated primary ITP and platelet counts under 30×10^9/L, randomizing them 1:1 to eltrombopag alone or eltrombopag plus a single rituximab infusion. All participants started eltrombopag 75 mg orally once daily with dose adjustments based on platelet counts through week 24, and the combination arm received rituximab 375 mg/m2 once within 14 days after enrollment. The primary comparison was efficacy and safety between the two arms, with secondary analyses including response in autoantibody‑positive patients and health‑related quality of life measures. Patients were followed at participating hematology centers for platelet responses and adverse events.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Signed written informed consent
2. Age from 18 to 60 years old
3. Diagnosed with ITP and have a platelet count of \<30 ×10\^9/L on Day 1 (or within 48 hours prior to dosing on Day 1).
4. Patients who have no response or relapsed after splenectomy(at least more than 6 months). Or patients who have not been splenectomised and have either not responded to one or more prior therapies, or who have relapsed prior therapy.
5. Subjects treated with previous therapy(including but not limited to corticosteroid, azathioprine, danazol, cyclosporin A, mycophenolate mofetil) must have been completed prior to randomization, or must not be increasing a dose after enrollment.
6. No pre-existing cardiac disease within the last 3 months. No arrhythmia known to increase the risk of thrombolic events (e.g. atrial fibrillation), or patients with a Corrected QT interval (QTc) \>450msec or QTc \>480 for patients with a Bundle Branch Block.
7. No pre-existing infection within the last 1 months(including but not limited to pulmonary infection)
8. Laboratory tests for coagulation function showed that prothrombin time (PT/INR) and activated partial thromboplastin time (APTT) no exceed normal by more than 20%. No history of clotting disorder, other than ITP.
9. White blood cell count, neutrophil absolute value, hemoglobin, within the reference range, with the following exceptions:

   * Hemoglobin: females and males 10.0 g/dl are eligible for inclusion,
   * Absolute neutrophil count (ANC) ≥1500/µL (1.5×109/L) is required for inclusion
10. The following blood chemistry test result no exceed normal by more than 20%:alanine aminotransferase, aspartate aminotransferase, total bilirubin, creatinine,serum albumin must not be below the lower limit of normal (LLN) by more than 10%.
11. Subject is non-childbearing potential of childbearing potential and use acceptable methods of contraception throughout the study.
12. Subjects fully understand and are able to comply with the requirements of the research protocol and are willing to complete the study as planned.

Exclusion Criteria:

1. Patients with any prior history of arterial or venous thrombosis, and with following risk factors: cancer, Factor V Leiden, ATIII deficiency, antiphospholipid syndrome.
2. Pregnant or lactating women;
3. Subjects is currently receiving treatment with another study medication.
4. Any laboratory or clinical evidence for HIV infection.
5. Any clinical history for hepatitis C infection; chronic hepatitis B infection; or any evidence for active hepatitis at the time of subject screening. Laboratory test shows positive serology for Hepatitis C or Hepatitis B (HB). In addition, if negative for HBsAg but HBcAb positive (regardless of HBsAb status), a HB DNA test will be performed and if positive the subject will be excluded.
6. History of platelet aggregation that prevents reliable measurement of platelet counts.
7. Any clinically relevant abnormality, other than ITP,which in the opinion of the investigator makes the subject unsuitable for participation in the study.

Where it's running

• Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
  Tianjin, China Recruiting

Study contacts

• Principal investigator: Lei Zhang, M.D., Ph.D — Institute of Hematology & Blood Diseases Hospital, China
• Study coordinator: Lei Zhang
• Email: zhanglei1@ihcams.ac.cn
• Phone: +86 13502118379

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Combining Belimumab with Rituximab for Chronic Immune Thrombocytopenia

  This study is testing if a new combination of two medications can help adults with chronic immune thrombocytopenia raise their platelet counts after other treatments have stopped working.

  Recruiting Phase 3 Assistance Publique - Hôpitaux de Paris · Créteil · NCT05338190

• Polatuzumab Vedotin plus Rituximab with Reduced-dose chemo for frail seniors with DLBCL

  This trial tests whether a gentler, first-line treatment (Polatuzumab Vedotin with Rituximab and reduced-dose chemo) helps older, frail patients with DLBCL stay disease-free longer.

  Recruiting Phase 4 The First Hospital of Jilin University · Changchun, Jilin · NCT07908888

• Chidamide, Lenalidomide, and Rituximab as induction therapy for newly diagnosed elderly or unfit double-expressor DLBCL

  This trial tests whether the combo of chidamide, lenalidomide, and rituximab can help treat newly diagnosed double-expressor DLBCL in people who are elderly or not fit for standard chemotherapy.

  Recruiting Phase 2 The First Affiliated Hospital with Nanjing Medical University · Nanjing, Jiangsu · NCT07884708

• Rituximab plus Cyclosporine for Primary Membranous Nephropathy

  This study tests whether adding Cyclosporine to Rituximab helps people with primary membranous nephropathy achieve remission of heavy protein in the urine faster.

  Recruiting Phase 2/3 Peking University First Hospital · Beijing · NCT07861204

• Glofitamab combo vs Rituximab combo with chemo for relapsed/refractory DLBCL

  This study tests whether glofitamab with chemotherapy (JS203-GemOx) helps patients with relapsed or refractory DLBCL more than rituximab with chemotherapy.

  Recruiting Phase 3 Shanghai Junshi Bioscience Co., Ltd. · Beijing, Beijing Municipality · NCT07808827

• Orelabrutinib plus Pola-R-CHP as first-line treatment for intermediate- to high-risk DLBCL

  This trial tests whether adding orelabrutinib to the Pola-R-CHP regimen can improve outcomes for adults with intermediate- to high-risk newly diagnosed DLBCL.

  Recruiting at 2 sites The First Affiliated Hospital of Xiamen University · Xiamen, Fujian and 1 other locations · NCT07778212

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.