Using Avatrombopag to treat low platelet counts from chemotherapy

Avatrombopag for Chemotherapy-induced Thrombocytopenia in Solid Tumors: a Prospective Multi-center One-arm Study

This study is testing if Avatrombopag can help people with low platelet counts caused by chemotherapy feel better when other treatments haven't worked.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Tianjin, Tianjin Municipality)
• Trial ID: NCT05218226 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of Avatrombopag in patients suffering from chemotherapy-induced thrombocytopenia (CIT) associated with solid tumors. 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 Avatrombopag. The study will monitor changes in platelet counts over a 24-week period and assess any adverse events during treatment. The findings will be compared to historical data from patients treated with other supportive therapies.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with chemotherapy-induced thrombocytopenia who have not responded to previous treatments.

Not a fit: Patients with uncontrolled primary diseases of important organs or those with severe comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve platelet counts in patients suffering from chemotherapy-induced thrombocytopenia, enhancing their quality of life and treatment outcomes.

How similar studies have performed: Previous studies have shown success with similar treatments for chemotherapy-induced thrombocytopenia, but this specific approach with Avatrombopag is relatively novel.

Eligibility criteria

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 this trial is running

Tianjin, Tianjin Municipality

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

Study contacts

• Principal investigator: Lei Zhang, MD — Chinese Academy of Medical Science and Blood Disease Hospital
• Study coordinator: Yunfei Chen, MD

Conditions Chemotherapy-induced Thrombocytopenia; Avatrombopag