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

NCT05411705 | Recruiting Phase 4

• 1 other identifier: FJ-KS-KY-2022-28(X)
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 15

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.

Conditions

Cancer Treatment Induced Thrombocytopenia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Proportion of patients whose platelet count is ≥ 75×10^9/L after 2 cycles cancer treatment.

  Efficacy was defined as treatment without salvage therapy to increase platelet counts.

  After 2 cycles cancer treatment (month 1.5~month 2, depends on chemotherapy regimen), each cycle is 14, 21 or 28 days

Secondary Outcomes (6)

• Proportion of patients receiving salvage treatment to increase platelet counts.

  during 3 cycles cancer treatment period(each cycle is 14, 21 or 28 days)

• 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

• Changes in neutrophile granulocyte count

  during 3 cycles cancer treatment period(each cycle is 14, 21 or 28 days)

Study Arms (2)

rhTPO

EXPERIMENTAL

The study in a 2:1 randomization ratio (110 subjects to rhTPO).

Drug: rhTPO

Control

OTHER

The study in a 2:1 randomization ratio (55 subjects to control group).

Drug: Control

Interventions

rhTPO DRUG

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.

Also known as: Recombinant human thrombopoietin, TPIAO

rhTPO

Control DRUG

Non-rhTPO treatment

Also known as: No intervention

Control

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patient provided signed informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Dalian Medical University: lead
• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: collaborator
• Anqing Municipal Hospital: collaborator
• Henan Cancer Hospital: collaborator
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator
• Peking University Shougang Hospital: collaborator
• Chinese PLA General Hospital: collaborator
• Liaoning Cancer Hospital & Institute: collaborator
• Tianjin Medical University Cancer Institute and Hospital: collaborator
• Henan Provincial People's Hospital: collaborator
• Shanxi Provincial Cancer Hospital: collaborator
• Beijing Sanhuan Cancer Hospital: collaborator
• Hebei Medical University Fourth Hospital: collaborator
• Tongji Hospital: collaborator
• The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China: collaborator
• Bethune Charitable Foundation: collaborator

Study Sites (15)

Anqing Municipal Hospital

Anqing, Anhui, 246003, China

RECRUITING

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

Beijing Chaoyang District Sanhuan Cancer Hospital

Beijing, Beijing Municipality, 100122, China

RECRUITING

Peking University Shougang Hospital

Beijing, Beijing Municipality, 100144, China

RECRUITING

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050011, China

NOT YET RECRUITING

Henan Provincial People's Hospital

Zhengzhou, Henan, 450003, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

RECRUITING

Union Hospital Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

RECRUITING

Tongji Hospital Tongji Medical College of Huazhong University of Science & Technology

Wuhan, Hubei, 430030, China

NOT YET RECRUITING

Affiliated Tumor Hospital of Nantong University

Nanyang, Jiangsu, 226001, China

RECRUITING

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, 116011, China

RECRUITING

Liaoning Cancer Hospital & Institute

Shenyang, Liaoning, 110801, China

RECRUITING

Shaanxi Provincial Cancer Hospital

Xi'an, Shaanxi, 710065, China

RECRUITING

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300181, China

RECRUITING

MeSH Terms

Interventions

Thrombopoietin

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Yunlong Xia, MD,PhD

  The First Affiliated Hospital of Dalian Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiwei Liu, MD

CONTACT

18098877966; jiweiliudl@126.com

Fengqi Fang, MD

CONTACT

18098876723; ffqlj@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: May 26, 2022
• First Posted: June 9, 2022
• Study Start: June 6, 2022
• Primary Completion: June 1, 2024
• Study Completion: August 1, 2024
• Last Updated: March 1, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: From 12 months 36 months after study completion.
• Access Criteria: Upon request to PI.

Locations

CN (15)