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

Primary Purpose

Cancer Treatment Induced Thrombocytopenia

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
rhTPO
Control
Sponsored by
The First Affiliated Hospital of Dalian Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer Treatment Induced Thrombocytopenia focused on measuring rhTPO, Prophylactic Treatment, Cancer Treatment Induced Thrombocytopenia, Treatment Induced Cardiac Injury

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 have had two platelet counts within 30×10^9-75×10^9/L measured at least 24 h apart during the previous chemotherapy cycle; 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.

Sites / Locations

  • Anqing Municipal HospitalRecruiting
  • Cancer Hospital Chinese Academy of Medical SciencesRecruiting
  • Penking University Shougang Hospital
  • Chinese PLA General HospitalRecruiting
  • The Fourth Hospital of Hebei Medical University
  • Harbin Medical University Cancer Hospital
  • Henan Provincial People's Hospital
  • Henan Cancer Hospital
  • Union Hospital Tongji Medical College, Huazhong University of Science and Technology
  • Tongji Hospital Tongji Medical College of Huazhong University of Science & Technology
  • Jilin Cancer Hospital
  • China-japan Union Hospital Of Jilin University
  • The First Affiliated Hospital of Dalian Medical UniversityRecruiting
  • Liaoning Cancer Hospital & InstituteRecruiting
  • Shaanxi Provincial cancer HospitalRecruiting
  • Shandong Cancer Hospital
  • Tianjin Medical University Cancer Tnstitute & Hospital
  • Cancer hospital of the University Chinese Academy of Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

rhTPO

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Proportion of patients receiving salvage treatment to increase platelet counts.
Salvage treatment including platelet infusion, rhIL-11, etc.
Changes in cTnT/cTnI
Changes in NT-proBNP
Changes in LVEF
LVEF will be assessed by echocardiography
Changes in neutrophile granulocyte count
Incidence of adverse events
treatment-related adverse events

Full Information

First Posted
May 26, 2022
Last Updated
January 3, 2023
Sponsor
The First Affiliated Hospital of Dalian Medical University
Collaborators
Shenyang Sunshine Pharmaceutical Co., LTD.
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1. Study Identification

Unique Protocol Identification Number
NCT05411705
Brief Title
Efficacy and Safety of rhTPO's Prophylactic Treatment of CTIT in Patients With High Risk of Cardiac Injury
Acronym
Circular
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 6, 2022 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital of Dalian Medical University
Collaborators
Shenyang Sunshine Pharmaceutical Co., LTD.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Treatment Induced Thrombocytopenia
Keywords
rhTPO, Prophylactic Treatment, Cancer Treatment Induced Thrombocytopenia, Treatment Induced Cardiac Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
165 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
rhTPO
Arm Type
Experimental
Arm Description
The study in a 2:1 randomization ratio (110 subjects to rhTPO).
Arm Title
Control
Arm Type
Other
Arm Description
The study in a 2:1 randomization ratio (55 subjects to control group).
Intervention Type
Drug
Intervention Name(s)
rhTPO
Other Intervention Name(s)
Recombinant human thrombopoietin, TPIAO
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Control
Other Intervention Name(s)
No intervention
Intervention Description
Non-rhTPO treatment
Primary Outcome Measure Information:
Title
Proportion of patients whose platelet count is ≥ 75×10^9/L after 2 cycles cancer treatment.
Description
Efficacy was defined as treatment without salvage therapy to increase platelet counts.
Time Frame
After 2 cycles cancer treatment (month 1.5~month 2, depends on chemotherapy regimen), each cycle is 14, 21 or 28 days
Secondary Outcome Measure Information:
Title
Proportion of patients receiving salvage treatment to increase platelet counts.
Description
Salvage treatment including platelet infusion, rhIL-11, etc.
Time Frame
during 3 cycles cancer treatment period(each cycle is 14, 21 or 28 days)
Title
Changes in cTnT/cTnI
Time Frame
1,3 and 6 months after initial treatment
Title
Changes in NT-proBNP
Time Frame
1,3 and 6 months after initial treatment
Title
Changes in LVEF
Description
LVEF will be assessed by echocardiography
Time Frame
1,3 and 6 months after initial treatment
Title
Changes in neutrophile granulocyte count
Time Frame
during 3 cycles cancer treatment period(each cycle is 14, 21 or 28 days)
Title
Incidence of adverse events
Description
treatment-related adverse events
Time Frame
from study start date to the end of follow-up, up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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: 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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiwei Liu, MD
Phone
18098877966
Email
jiweiliudl@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Fengqi Fang, MD
Phone
18098876723
Email
ffqlj@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yunlong Xia, MD,PhD
Organizational Affiliation
The First Affiliated Hospital of Dalian Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anqing Municipal Hospital
City
Anqing
State/Province
Anhui
ZIP/Postal Code
246003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chenghui Li
Phone
15856555363
Facility Name
Cancer Hospital Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shengyu Zhou
Phone
13520852899
Facility Name
Penking University Shougang Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100144
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaodong Wang
Phone
010-57830282
Facility Name
Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuechun Lu
Phone
13241892863
Facility Name
The Fourth Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050011
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jian Shi
Phone
13831110729
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150081
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aichun Liu
Phone
13633611958
Facility Name
Henan Provincial People's Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450003
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shundong Cang
Phone
13592675836
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jufeng Wang
Phone
13783583966
Facility Name
Union Hospital Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gang Wu
Phone
13871240042
Facility Name
Tongji Hospital Tongji Medical College of Huazhong University of Science & Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yongsheng Jiang
Phone
15327434928
Facility Name
Jilin Cancer Hospital
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130012
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ying Cheng
Phone
13943012851
Facility Name
China-japan Union Hospital Of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130033
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuansong Bai
Phone
13944082211
Facility Name
The First Affiliated Hospital of Dalian Medical University
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiwei Liu
Phone
18098877966
Email
jiweiliudl@126.com
First Name & Middle Initial & Last Name & Degree
Fengqi Fang
Phone
18098876723
Email
ffqlj@163.com
Facility Name
Liaoning Cancer Hospital & Institute
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110801
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tao Sun
Phone
18900917877
Facility Name
Shaanxi Provincial cancer Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710065
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guoqing Wang
Phone
13892828647
Facility Name
Shandong Cancer Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250117
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Changzhang Li
Phone
15553119057
Facility Name
Tianjin Medical University Cancer Tnstitute & Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300181
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huilai Zhang
Phone
18622221228
Facility Name
Cancer hospital of the University Chinese Academy of Sciences
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
11008795
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaojia Wang
Phone
13906500190

12. IPD Sharing Statement

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

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