Clinical trial NCT05350956: A Clinical Study of Herombopag in Tumors-associated Thrombocytopenia
Official title: A Prospective, Multi-cohort, Open-label Clinical Study of the Efficacy and Safety of Herombopag in Tumors-associated Thrombocytopenia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Tumor Therapy-related Thrombocytopenia
Lead sponsor: The First Affiliated Hospital of Zhengzhou University
Sponsor class: OTHER
Collaborators: name: Jiangsu HengRui Medicine Co., Ltd.
First posted: 2022-04-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to confirm the safety and efficacy of Herombopag in tumors-associated thrombocytopenia

Detailed description: CIT is one of the most common complications of tumor treatment, which is caused by the inhibition of anticancer chemotherapy drugs on megakaryocytes in bone marrow, resulting in platelet count lower than 100×109/L in peripheral blood, and is a common hematological toxic reaction in clinic. CIT leads to an increased risk of bleeding and transfusion, and severe CIT can cause intracranial bleeding and death. The use of platelet infusion is limited and ineffective in 25% of patients. rhIL-11 increases the incidence of cardiovascular events and rhTPO may produce immunogenicity. Currently, TPO-RA is recommended for the treatment of CIT by consensus guidelines at home and abroad. The study was designed to explore the safety and efficacy of Herombopag in the treatment of tumour-associated thrombocytopenia.

Eligibility criteria: Inclusion Criteria:

1. Age ≥18, no gender limitation;
2. Participants with solid tumors confirmed by histopathological or cytological examination;
3. During the current tumor treatment cycle, the participants whose PLT\<50×109/L, and will receive the current tumor treatment regimen for at least 1 cycle;
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
5. Voluntarily participated in the study and signed the informed consent with good compliance.

Exclusion Criteria:

1. Suffering from any of the following diseases of the hematopoietic system other than thrombocytopenia caused by tumor therapy, including but not limited to leukemia, primary immune thrombocytopenia, myeloid proliferative disease, multiple myeloma and myelodysplastic syndrome;
2. Suffering from thrombocytopenia (not caused by tumor treatment), including but not limited to chronic liver disease, hypersplenism, infection, and bleeding, within 6 months prior to screening;
3. Bone marrow invasion or bone marrow metastasis;
4. Received radiation therapy to the pelvis, spine and bone field within 3 months prior to screening; or is/is expected to receive radiation therapy.
5. Received TPO-RA drugs (such as altrepopal and romistine), or rhTPO or rhIL-11 in the current cancer treatment cycle;
6. Received platelet transfusion within 3 days prior to randomization;
7. Participants with known or expected allergy or intolerance to the active ingredient or excipient of Herombopag Olamine tablets;
8. Pregnant or lactating women;
9. Participants who are participating in other clinical trials.
10. Other conditions that the investigator determines are not suitable for inclusion in the study.

Primary outcomes:
measure: During the correction period, the percentage of patients whose platelets returned to normal within 14 days
timeFrame: up to 14 days
Secondary outcomes:
measure: During the correction period, the median time for platelet values to return to normal
timeFrame: up to 60 days
measure: During the correction period, the Median time for platelet count to return to 75×109/L
timeFrame: up to 60 days
measure: During the correction period, the median time for platelet count to return to 50×109/L
timeFrame: up to 60 days
measure: During the correction period, the percentage of patients whose platelets returned to75×109/L within 14 days
timeFrame: up to 14 days
measure: During the correction period, the percentage of patients whose platelets returned to 50×109/L within 14 days
timeFrame: up to 14 days
measure: During the correction period, platelet infusion rate after initiation of Herombopag therapy.
timeFrame: up to 14 days
measure: During the prophylaxis period, the proportion of patients whose PLT<75×109/L
timeFrame: up to 14 days
measure: During the prophylaxis period, the proportion of patients whose PLT<50×109/L
timeFrame: up to 14 days
measure: During the prophylaxis period, platelet counts are at their lowest.
timeFrame: up to 14 days
measure: During the prophylaxis period, platelet infusion rate after initiation of Herombopag therapy.
timeFrame: up to 14 days
measure: Platelet value curve
timeFrame: up to 60 days
Other outcomes:
Locations:
Study officials:
affiliation: The First Affiliated Hospital of Zhengzhou University
name: Zong Hong, Professor
role: PRINCIPAL_INVESTIGATOR
References: