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A ClinicaI Investigation on the Safety and Effectiveness of Hetrombopag for the Secondary Prevention of Thrombocytopenia Associated with the Treatment of Lymphoma

A Clinical Investigation on the Safety and Effectiveness of Hetrombopag for Thrombocytopenia Associated with the Treatment of Lymphoma

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400094077
Enrollment
Unknown
Registered
2024-12-17
Start date
2024-12-20
Completion date
Unknown
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chemotherapy-related thrombocytopenia

Interventions

Sponsors

The Affiliated Cancer Hospital of Shandong First Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients signed informed consent and voluntarily joined the study; 2. Age >= 18 years old, male or female; 3. ECOG score = 6 months; 5. The patient was diagnosed with lymphoma by histopathological examination; 6. Patients who have undergone standard chemotherapy; 7. Patients with lymphoma who are in the anti-tumor treatment cycle and plan to continue with the same treatment regimen for at least 1 week Period; 8. PLT < 50×10^9 occurred in the last treatment cycle/L; 9. The patient's laboratory test results meet the following criteria: a. Alanine aminotransferase (ALT) <= 3.0× upper limit of normal (ULN), aspartate aminotransferase (AST) <= 3.0×ULN; b. Serum total bilirubin <= 1.5×ULN; c. Serum creatinine <= 1.5×ULN; 10. The researchers determined that the patient could be treated with Hetrombopag.

Exclusion criteria

Exclusion criteria: 1. Have a history of allergy to thrombopoietin receptor agonists; 2. Combined with aplastic anemia, primary immune thrombocytopenia and other diseases leading to thrombocytopenia; 3. Severe bleeding symptoms, such as gastrointestinal bleeding, bleeding of important organs, and intracranial bleeding;New thrombotic diseases were found within; 4.6 months, such as cerebral infarction, arterial thrombosis, deep vein thrombosis, pulmonary embolism, etc. 5. Hypercoagulable state and disseminated intravascular coagulation (DIC); 6. Primary thrombocythemia; 7. Positive anti-human immunodeficiency virus antibody or anti-treponema pallidum specific antibody; 8. New York Heart Association (NYHA) Grade 3 or 4 congestive heart failure; 9. History of uncontrollable angina pectoris, myocardial infarction or cerebral infarction within 6 months before the screening period; 10. Have an active infection that is difficult to control; 11. History of rheumatic immune system disease; 12. A history of tumor infiltration in bone marrow; 13. Pregnant or lactating women; 14. Other conditions determined by the investigator to be unsuitable for inclusion in the study.

Design outcomes

Primary

MeasureTime frame
Incidence of platelets < 50×10^9;

Secondary

MeasureTime frame
Duration of PLT = 4 days or whose treatment reduction is >= 15% or whose treatment is terminated due to thrombocytopenia ;The proportion of patients with platelet elevation salvage therapy (including rhTPO, platelet infusion, etc.) in this treatment cycle ;Incidence and severity of adverse events;

Countries

China

Contacts

Public ContactZengjun Li

The Affiliated Cancer Hospital of Shandong First Medical University

zengjunli@163.com+86 136 4213 8692

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026