Efficacy and Safety of rhTPO's Prophylactic Treatment of CTIT in Patients With High Risk of Cardiac Injury

Launched by THE FIRST AFFILIATED HOSPITAL OF DALIAN MEDICAL UNIVERSITY · Jun 6, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at a treatment called rhTPO, which may help prevent a condition called cancer treatment-induced thrombocytopenia (CTIT) in patients who are at high risk of developing it. CTIT occurs when cancer treatments lower the number of platelets in the blood, which can increase the risk of bleeding. The study aims to see if a specific dosing plan for rhTPO can effectively prevent this condition and also protect the heart in patients undergoing cancer treatment.

To participate in this trial, individuals must be at least 18 years old and have a history of low platelet counts or meet certain risk factors for bleeding. Eligible patients should have a platelet count between 75 and 150, and they should be receiving ongoing cancer treatment. Participants will be monitored for how well the treatment works and any side effects. It's important to note that people with certain serious health conditions, such as severe heart disease or recent blood disorders, cannot take part in this study. If you're interested or think you may qualify, discussing this with your healthcare provider can provide more personalized information.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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:
• • 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:
• • 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.