Status:
RECRUITING
Efficacy and Safety of rhTPO's Prophylactic Treatment of CTIT in Patients With High Risk of Cardiac Injury
Lead Sponsor:
The First Affiliated Hospital of Dalian Medical University
Collaborating Sponsors:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Anqing Municipal Hospital
Conditions:
Cancer Treatment Induced Thrombocytopenia
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
Brief Summary
To assess the efficacy and safety of an optimised dosing regimen of rhTPO's prophylactic treatment of cancer treatment-induced thrombocytopenia(CTIT) and to explore the cardioprotective effect of rhTP...
Detailed Description
This is an open-label prospective randomized multicenter study of rhTPO's prophylactic treatment of CTIT in patients receiving chemotherapy at high risk of cardiac injury. Adult cancer patients with h...
Eligibility Criteria
Inclusion
- Males or females greater than or equal to 18 years of age at signing of the informed consent.
- Patients clinically judged to be at high risk of CTIT: Patients who had a platelet count below 50×10\^9/L in the past 3 months; or patients who meet the criteria for prophylactic treatment in the Chinese Expert Consensus on the Management of Thrombocytopenia due to Oncology Chemotherapy (2018 Edition).The criteria for prophylactic treatment include: 1) The nadir platelet value in the last chemotherapy cycle was \<50×10\^9/L；Or 2)The patients with nadir platelet value ≥50×10\^9/L and \<75×10\^9/L in the previous chemotherapy cycle also met at least one of the following risk factors for bleeding:
- With a previous history of bleeding.
- Chemotherapy regimens containing platinum, gemcitabine, cytarabine, anthracycline, etc.
- Combination regimens containing targeted or chemotherapy drugs which regularly result in thrombocytopenia.
- Thrombocytopenia caused by bone marrow infiltration of tumor cells.
- Eastern Cooperative Oncology Group (ECOG) score ≥2.
- Previous radiotherapy or ongoing radiotherapy, especially for long and flat bones (e.g. pelvis, sternum, etc.).
- Platelet count ≥75×10\^9/L and \<150×10\^9/L, Hemoglobin ≥9.0 g/dL and absolute neutrophils ≥1.5×10\^9 /L during screening.
- Patients with medium and high-risk with cardiotoxicity risk score (CRS) ≥3 and ECOG score of 0, 1, or 2 during screening.
- The current tumor treatment belongs to the scope of neoadjuvant, adjuvant, relapsed metastatic/advanced first-line and second-line therapies, anticipated to receive at least 2 cycles of current regimen with survival ≥ 6 months. The regimens may be 14-day, 21-day or 28-day cycles combined with targeted, immunotherapy, etc.
- Inclusion of organ tumours and lymphomas, with no restriction on the type and stage of organ tumours, etc.
- Patient provided signed informed consent
Exclusion
- Patients with severe cerebrovascular disease (including but not limited to stroke, cerebrovascular accident, etc.) or serious heart disease (such as heart valve disease, arrhythmia, myocardial infarction, congenital heart disease, cardiomyopathy, heart failure, etc.) within the 3 months.
- Previous thrombocytopenia caused by non-oncology chemotherapy drugs within 6 months, including but not limited to primary immune thrombocytopenia, EDTA-dependent pseudo-thrombocytopenia, hypersplenism, etc.
- Patients with blood dysplasia-related diseases such as aplastic anemia, myeloproliferative diseases, multiple myeloma, myelodysplastic syndromes, etc.
- Patients with any arterial and venous thrombotic events within the past 6 months；
- Patients who had agents that increase platelet production or transfusion of platelets within the past 1 month.
- Abnormal liver function:
- Patients without liver metastasis: ALT/AST \> 3ULN (upper limit of normal value) and TBIL \> 3ULN.
- Patients with liver metastasis: ALT/AST≥5ULN, TBIL≥5ULN.
- Abnormal renal function: Scr≥1.5ULN or eGFR≤60ml/min.
- Patients with uncontrolled serious infection;
- Pregnant women or those planning to have children during the study period and breastfeeding patients.
- Any condition that the investigator considers inappropriate for inclusion in this study.
Key Trial Info
Start Date :
June 6 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2024
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT05411705
Start Date
June 6 2022
End Date
August 1 2024
Last Update
March 1 2024
Active Locations (15)
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1
Anqing Municipal Hospital
Anqing, Anhui, China, 246003
2
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
3
Beijing Chaoyang District Sanhuan Cancer Hospital
Beijing, Beijing Municipality, China, 100122
4
Peking University Shougang Hospital
Beijing, Beijing Municipality, China, 100144