Eltrombopag treatment for low platelet counts caused by chemotherapy

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 clinical trial evaluates the safety and efficacy of eltrombopag in patients suffering from chemotherapy-induced thrombocytopenia (CIT). It is a single-arm study where participants who have previously not responded to treatments like recombinant human thrombopoietin (rhTPO) or interleukin 11 (IL-11) will receive eltrombopag. The study will monitor changes in platelet counts over a 24-week period and assess any adverse events during treatment. The goal is to determine if eltrombopag can effectively increase platelet levels in these patients.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Aged ≥18 years old, male or female;
* Conform to the diagnostic criteria of chemotherapy-induced thrombocytopenia (CIT); Ineffective after repeated treatment with rhTPO or IL-11；
* Stop radiotherapy or chemotherapy for more than 1 month;
* Platelet counts \<30 ×10\^9/L, and bleeding tendency;
* Estimated survival period ≥ 6 months；
* People who are willing to sign the informed consent voluntarily and follow the research program.
* Liver and kidney function\<1.5×upper limit of normal, qualified for physical examination；
* Subject is practicing an acceptable method of contraception. Women of childbearing potential must have a negative serum pregnancy test in the whole study;

Exclusion Criteria:

* Those with uncontrollable primary diseases of important organs, such as extensive metastasis of malignant tumors, liver failure, heart failure, kidney failure and other diseases；
* Patients with poor compliance;
* Positive serology for HIV, hepatitis B virus (HBV), hepatitis C virus (HCV), and/or hepatitis D virus (HDV), Syphilis; Positive for Epstein-Barr Virus DNA, Cytomegalovirus DNA;
* Accompanied by extensive and severe bleeding, such as hemoptysis, upper gastrointestinal bleeding, intracranial hemorrhage, etc.
* There is currently a heart disease requiring treatment or a poorly controlled hypertension judged by the investigator；
* Patients with thrombotic diseases such as pulmonary embolism, thrombosis, and atherosclerosis；
* Those who have received allogeneic stem cell transplantation or organ transplantation in the past；
* Patients with mental disorders who cannot normally obtain informed consent and undergo trials and follow-up；
* Patients whose toxic symptoms caused by treatment before participating in the trial have not disappeared；
* Other serious diseases that may restrict participants from participating in this trial (such as diabetes; severe heart failure; myocardial obstruction or unstable arrhythmia or unstable angina in the past 6 months; gastric ulcers; mobility Autoimmune diseases, etc.)；
* Patients with sepsis or patients with other irregular bleeding；
* Patients taking antiplatelet drugs at the same time；
* Pregnant women, suspected pregnancy (a positive pregnancy test for human chorionic gonadotropin in urine at screening) and breastfeeding patients；
* Pre-existing cardiac disease, including congestive heart failure of New York Heart Association \[NYHA\] Grade III/IV, arrhythmia requiring treatment or myocardial infarction within the last 6 months. No arrhythmia known to increase the risk of thrombotic events (e.g. atrial fibrillation), or patients with a QT \>450msec or QTc \> 480 for patients with a Bundle Branch Block;
* Researchers believe that patients should not participate in the test of any other condition.

Where it's running

• Chinese Academy of Medical Science and Blood Disease Hospital
  Tianjin, Tianjin Municipality, China Recruiting

Study contacts

• Principal investigator: Lei Zhanglei, MD — Chinese Academy of Medical Science and Blood Disease Hospital
• Study coordinator: Yunfei Chen, MD
• Email: chenyunfei@ihcams.ac.cn
• Phone: +86-22-23909009

Similar studies

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

• Romiplostim N01 plus ATRA for persistent chemotherapy-induced low platelets after remission from gynecologic, breast, or lung cancer

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• Romiplostim N01 to treat chemotherapy-related low platelets

  This will test whether Romiplostim N01 can raise platelet counts in adults whose platelets remain very low after chemotherapy and did not respond to other platelet-boosting drugs.

  Recruiting Phase 2 Institute of Hematology & Blood Diseases Hospital, China · Tianjin, Tianjin Municipality · NCT07063225

• Romiplostim to prevent chemotherapy-related low platelets in Ewing sarcoma

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• Romiplostim N01 for chemotherapy-related low platelets in children and young adults

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• Home monitoring of blood tests for cancer patients

  This study is testing if cancer patients can do their blood tests at home during chemotherapy to make things easier and improve their care.

  Recruiting at 5 sites Pomeranian Medical University Szczecin · Næstved, Region Sjælland and 4 other locations · NCT06809101

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.