Prophylactic treatment for cancer patients at risk of low platelet counts and heart injury

A Multicenter Randomized Controlled Study to Assess the Efficacy and Safety of rhTPO's Prophylactic Treatment of Cancer Treatment-induced Thrombocytopenia in Patients With High Risk of Treatment-induced Cardiac Injury

This study is testing if a new treatment called rhTPO can help cancer patients at risk of low platelet counts and heart problems feel better during their chemotherapy.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 165 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: The First Affiliated Hospital of Dalian Medical University (Academic / other)
• Drugs / interventions: Chemotherapy, immunotherapy
• Locations: 15 sites (Anqing, Anhui and 14 other locations)
• Trial ID: NCT05411705 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of rhTPO as a prophylactic treatment for cancer treatment-induced thrombocytopenia (CTIT) in patients at high risk of cardiac injury. It is an open-label, prospective, randomized, multicenter trial where adult cancer patients will be assigned to either receive rhTPO or standard treatment. The rhTPO group will receive subcutaneous injections of rhTPO for five days per chemotherapy cycle over three cycles. The primary goal is to assess improvements in platelet counts during the treatment period.

Who should consider this trial

Good fit: Ideal candidates are adult cancer patients aged 18 and older who are at high risk for CTIT and cardiac injury.

Not a fit: Patients who do not have a history of low platelet counts or are not at high risk for treatment-induced cardiac injury may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the incidence of thrombocytopenia and cardiac injury in cancer patients undergoing chemotherapy.

How similar studies have performed: Other studies have shown promising results with similar prophylactic treatments in managing chemotherapy-induced complications, suggesting potential for success in this approach.

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.

Where this trial is running

Anqing, Anhui and 14 other locations

• Anqing Municipal Hospital — Anqing, Anhui, China (Recruiting)
• Cancer Hospital Chinese Academy of Medical Sciences — Beijing, Beijing, China (Recruiting)
• Beijing Chaoyang District Sanhuan Cancer Hospital — Beijing, Beijing, China (Recruiting)
• Peking University Shougang Hospital — Beijing, Beijing, China (Recruiting)
• Chinese PLA General Hospital — Beijing, Beijing, China (Recruiting)
• The Fourth Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (Not_yet_recruiting)
• Henan Provincial People's Hospital — Zhengzhou, Henan, China (Recruiting)
• Henan Cancer Hospital — Zhengzhou, Henan, China (Recruiting)
• Union Hospital Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
• Tongji Hospital Tongji Medical College of Huazhong University of Science & Technology — Wuhan, Hubei, China (Not_yet_recruiting)
• Affiliated Tumor Hospital of Nantong University — Nanyang, Jiangsu, China (Recruiting)
• The First Affiliated Hospital of Dalian Medical University — Dalian, Liaoning, China (Recruiting)
• Liaoning Cancer Hospital & Institute — Shenyang, Liaoning, China (Recruiting)
• Shaanxi Provincial Cancer Hospital — Xi'an, Shaanxi, China (Recruiting)
• Tianjin Medical University Cancer Institute and Hospital — Tianjin, Tianjin, China (Recruiting)

Study contacts

• Principal investigator: Yunlong Xia, MD,PhD — The First Affiliated Hospital of Dalian Medical University
• Study coordinator: Jiwei Liu, MD

Conditions Cancer Treatment Induced Thrombocytopenia; rhTPO; Prophylactic Treatment; Treatment Induced Cardiac Injury