Efficacy and Safety of rhTPO's Prophylactic Treatment of CTIT in Patients With High Risk of Cardiac Injury
NCT ID: NCT05411705
Last Updated: 2024-03-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
165 participants
INTERVENTIONAL
2022-06-06
2024-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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rhTPO
The study in a 2:1 randomization ratio (110 subjects to rhTPO).
rhTPO
rhTPO 300U/kg/d QD, subcutaneous injection applied for 5 days per cycle, total 3 cycles. If the patient's platelet count showed a trend of continuous decline and/or was accompanied by the risk of bleeding during the treatment or after the completion of 5 doses of rhTPO, the investigator judged that rhTPO should be continued for treatment, and rhTPO could be administered subcutaneously at 300U/kg/ day for a maximum of 14 doses per cycle. Discontinue when the absolute platelet count increases by ≥50×10\^9/L or when the platelet count rises to ≥250×10\^9/L.
Control
The study in a 2:1 randomization ratio (55 subjects to control group).
Control
Non-rhTPO treatment
Interventions
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rhTPO
rhTPO 300U/kg/d QD, subcutaneous injection applied for 5 days per cycle, total 3 cycles. If the patient's platelet count showed a trend of continuous decline and/or was accompanied by the risk of bleeding during the treatment or after the completion of 5 doses of rhTPO, the investigator judged that rhTPO should be continued for treatment, and rhTPO could be administered subcutaneously at 300U/kg/ day for a maximum of 14 doses per cycle. Discontinue when the absolute platelet count increases by ≥50×10\^9/L or when the platelet count rises to ≥250×10\^9/L.
Control
Non-rhTPO treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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:
1. With a previous history of bleeding.
2. Chemotherapy regimens containing platinum, gemcitabine, cytarabine, anthracycline, etc.
3. Combination regimens containing targeted or chemotherapy drugs which regularly result in thrombocytopenia.
4. Thrombocytopenia caused by bone marrow infiltration of tumor cells.
5. Eastern Cooperative Oncology Group (ECOG) score ≥2.
6. 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 Criteria
* 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.
18 Years
85 Years
ALL
No
Sponsors
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Cancer Institute and Hospital, Chinese Academy of Medical Sciences
OTHER
Anqing Municipal Hospital
OTHER
Henan Cancer Hospital
OTHER_GOV
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
Peking University Shougang Hospital
OTHER
Chinese PLA General Hospital
OTHER
Liaoning Cancer Hospital & Institute
OTHER
Tianjin Medical University Cancer Institute and Hospital
OTHER
Henan Provincial People's Hospital
OTHER
Shaanxi Provincial Cancer Hospital
OTHER
Beijing Sanhuan Cancer Hospital
UNKNOWN
Hebei Medical University Fourth Hospital
OTHER
Tongji Hospital
OTHER
The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China
OTHER
Bethune Charitable Foundation
UNKNOWN
The First Affiliated Hospital of Dalian Medical University
OTHER
Responsible Party
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Xia Yunlong
Director
Principal Investigators
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Yunlong Xia, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Dalian Medical University
Locations
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Anqing Municipal Hospital
Anqing, Anhui, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Beijing Chaoyang District Sanhuan Cancer Hospital
Beijing, Beijing Municipality, China
Peking University Shougang Hospital
Beijing, Beijing Municipality, China
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Union Hospital Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Tongji Hospital Tongji Medical College of Huazhong University of Science & Technology
Wuhan, Hubei, China
Affiliated Tumor Hospital of Nantong University
Nanyang, Jiangsu, China
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, China
Shaanxi Provincial Cancer Hospital
Xi'an, Shaanxi, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Chenghui Li
Role: primary
Shengyu Zhou
Role: primary
Xiaodong Wang
Role: primary
Xuechun Lu
Role: primary
Jian Shi
Role: primary
Shundong Cang
Role: primary
Jufeng Wang
Role: primary
Gang Wu
Role: primary
Yongsheng Jiang
Role: primary
Tao Sun
Role: primary
Guoqing Wang
Role: primary
Huilai Zhang
Role: primary
Other Identifiers
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FJ-KS-KY-2022-28(X)
Identifier Type: -
Identifier Source: org_study_id
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