Efficacy and Safety of rhTPO's Prophylactic Treatment of CTIT in Patients With High Risk of Cardiac Injury
- Conditions
- Cancer Treatment Induced Thrombocytopenia
- Interventions
- Drug: Control
- Registration Number
- NCT05411705
- Lead Sponsor
- The First Affiliated Hospital of Dalian Medical University
- 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 rhTPO in cancer patients with high risk of treatment-induced cardiac injury.
- 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 high risk of cancer treatment-induced thrombocytopenia and cardiac injury were enrolled. Patients will be randomised into the rhTPO treatment group or non-rhTPO treatment group with a 2:1 ratio. The patients in rhTPO group will receive rhTPO 300U/kg/d subcutaneous injection for 5 days per cycle and total 3 cycles. The primary endpoint is to observe the improvement of platelet count by rhTPO during 3 cycles treatment period.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 165
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Males or females greater than or equal to 18 years of age at signing of the informed consent.
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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.).
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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.
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Patients with medium and high-risk with cardiotoxicity risk score (CRS) ≥3 and ECOG score of 0, 1, or 2 during screening.
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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.
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Inclusion of organ tumours and lymphomas, with no restriction on the type and stage of organ tumours, etc.
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Patient provided signed informed consent
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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.
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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.
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Patients with blood dysplasia-related diseases such as aplastic anemia, myeloproliferative diseases, multiple myeloma, myelodysplastic syndromes, etc.
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Patients with any arterial and venous thrombotic events within the past 6 months；
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Patients who had agents that increase platelet production or transfusion of platelets within the past 1 month.
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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.
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Abnormal renal function: Scr≥1.5ULN or eGFR≤60ml/min.
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Patients with uncontrolled serious infection;
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Pregnant women or those planning to have children during the study period and breastfeeding patients.
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Any condition that the investigator considers inappropriate for inclusion in this study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Control The study in a 2:1 randomization ratio (55 subjects to control group). rhTPO rhTPO The study in a 2:1 randomization ratio (110 subjects to rhTPO).
- Primary Outcome Measures
Name Time Method Proportion of patients whose platelet count is ≥ 75×10^9/L after 2 cycles cancer treatment. After 2 cycles cancer treatment (month 1.5~month 2, depends on chemotherapy regimen), each cycle is 14, 21 or 28 days Efficacy was defined as treatment without salvage therapy to increase platelet counts.
- Secondary Outcome Measures
Name Time Method Proportion of patients receiving salvage treatment to increase platelet counts. during 3 cycles cancer treatment period(each cycle is 14, 21 or 28 days) Salvage treatment including platelet infusion, rhIL-11, etc.
Changes in cTnT/cTnI 1 and 3 months after initial treatment Changes in NT-proBNP 1 and 3 months after initial treatment Changes in LVEF 1 and 3 months after initial treatment LVEF will be assessed by echocardiography
Changes in neutrophile granulocyte count during 3 cycles cancer treatment period(each cycle is 14, 21 or 28 days) Incidence of adverse events from study start date to the end of follow-up, up to 3 months treatment-related adverse events
Trial Locations
- Locations (15)
Anqing Municipal Hospital
🇨🇳Anqing, Anhui, China
Peking University Shougang Hospital
🇨🇳Beijing, Beijing, China
Cancer Hospital Chinese Academy of Medical Sciences
🇨🇳Beijing, Beijing, China
Chinese PLA General Hospital
🇨🇳Beijing, Beijing, China
The Fourth Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
Henan Provincial People's Hospital
🇨🇳Zhengzhou, Henan, China
Union Hospital Tongji Medical College, Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
Affiliated Tumor Hospital of Nantong University
🇨🇳Nanyang, Jiangsu, China
Tongji Hospital Tongji Medical College of Huazhong University of Science & Technology
🇨🇳Wuhan, Hubei, China
Shaanxi Provincial Cancer Hospital
🇨🇳Xi'an, Shaanxi, China
Tianjin Medical University Cancer Institute and Hospital
🇨🇳Tianjin, Tianjin, China
Beijing Chaoyang District Sanhuan Cancer Hospital
🇨🇳Beijing, Beijing, China
Henan Cancer Hospital
🇨🇳Zhengzhou, Henan, China
The First Affiliated Hospital of Dalian Medical University
🇨🇳Dalian, Liaoning, China
Liaoning Cancer Hospital & Institute
🇨🇳Shenyang, Liaoning, China