Cancer Treatment Induced ThrombocytopeniaPhase 4CircularNCT05411705
Efficacy and Safety of rhTPO's Prophylactic Treatment of CTIT in Patients With High Risk of Cardiac Injury
A Phase 4 study testing rhTPO in people with Cancer Treatment Induced Thrombocytopenia, run by The First Affiliated Hospital of Dalian Medical University at 15 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cancer Treatment Induced Thrombocytopenia
- What is being tested?
- rhTPO
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 15 sitesChina
- Study dates
- 6 Jun 2022to Aug 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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:
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- 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.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
China15 sites, 15 recruiting
- Recruiting
Anqing Municipal Hospital
Anqing, Anhui, 246003
Chenghui Li, 15856555363
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Shengyu Zhou, 13520852899
- Recruiting
Beijing Chaoyang District Sanhuan Cancer Hospital
Beijing, Beijing Municipality, 100122
Lijie Zuo, zuolijie@163.com
- Recruiting
Peking University Shougang Hospital
Beijing, Beijing Municipality, 100144
Xiaodong Wang, 010-57830282
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Xuechun Lu, 13241892863
- Recruiting
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 116011
Jiwei Liu, 18098877966, jiweiliudl@126.com
Fengqi Fang, 18098876723, ffqlj@163.com
- Recruiting
Affiliated Tumor Hospital of Nantong University
Nanyang, Jiangsu, 226001
Lei Yang, 15851398092, 1341320416@qq.com
- Recruiting
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, 110801
Tao Sun, 18900917877
- Not yet recruiting
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050011
Jian Shi, 13831110729
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300181
Huilai Zhang, 18622221228
- Recruiting
Union Hospital Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Gang Wu, 13871240042
- Not yet recruiting
Tongji Hospital Tongji Medical College of Huazhong University of Science & Technology
Wuhan, Hubei, 430030
Yongsheng Jiang, 15327434928
- Recruiting
Shaanxi Provincial Cancer Hospital
Xi'an, Shaanxi, 710065
Guoqing Wang, 13892828647
- Recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan, 450003
Shundong Cang, 13592675836
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450008
Jufeng Wang, 13783583966
About this study
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
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.
Read the 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.
- Being tested
- rhTPO, Control
- Keywords
- rhTPO, Prophylactic Treatment, Cancer Treatment Induced Thrombocytopenia, Treatment Induced Cardiac Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rhTPODrug
Also called Recombinant human thrombopoietin, TPIAO
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.
ControlDrug
Also called No intervention
Non-rhTPO treatment
| Study group | Role | What they receive |
|---|---|---|
| rhTPO | Experimental | The study in a 2:1 randomization ratio (110 subjects to rhTPO). Receives: Drug: rhTPO |
| Control | Other | The study in a 2:1 randomization ratio (55 subjects to control group). Receives: Drug: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Salvage treatment including platelet infusion, rhIL-11, etc.
Measured: during 3 cycles cancer treatment period(each cycle is 14, 21 or 28 days)
Changes in cTnT/cTnI
Measured: 1 and 3 months after initial treatment
Changes in NT-proBNP
Measured: 1 and 3 months after initial treatment
Changes in LVEF
LVEF will be assessed by echocardiography
Measured: 1 and 3 months after initial treatment
Changes in neutrophile granulocyte count
Measured: during 3 cycles cancer treatment period(each cycle is 14, 21 or 28 days)
Incidence of adverse events
treatment-related adverse events
Measured: from study start date to the end of follow-up, up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start6 Jun 2022
- Primary completionJun 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer Treatment Induced ThrombocytopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Dalian Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Anqing Municipal Hospital, Henan Cancer Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Peking University Shougang Hospital, Chinese PLA General Hospital, Liaoning Cancer Hospital & Institute, Tianjin Medical University Cancer Institute and Hospital, Henan Provincial People's Hospital, Shanxi Province Cancer Hospital, Beijing Sanhuan Cancer Hospital, Hebei Medical University Fourth Hospital, Tongji Hospital, The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China, Bethune Charitable Foundation
- Responsible party
- Principal investigator, Xia Yunlong, The First Affiliated Hospital of Dalian Medical University
- Investigators
- Yunlong Xia, MD,PhD, Principal investigator, The First Affiliated Hospital of Dalian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05411705
- Sponsor's protocol ID
- FJ-KS-KY-2022-28(X)
- Acronym
- Circular
- Status last verified
- Feb 2024
- First submitted
- 26 May 2022
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Researchers qualified can request the dataset, including de-identified individual subject data. Data may be requested from PI from 12 months 36 months after study completion.
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05411705
- Acronym / sponsor ID
- Circular / FJ-KS-KY-2022-28(X)
- Keywords
- rhTPO, Prophylactic Treatment, Cancer Treatment Induced Thrombocytopenia, Treatment Induced Cardiac Injury
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Dalian Medical UniversityUniversity, hospital or other
- Collaborators
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Anqing Municipal Hospital, Henan Cancer Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Peking University Shougang Hospital, Chinese PLA General Hospital, Liaoning Cancer Hospital & Institute, Tianjin Medical University Cancer Institute and Hospital, Henan Provincial People's Hospital, Shanxi Province Cancer Hospital, Beijing Sanhuan Cancer Hospital, Hebei Medical University Fourth Hospital, Tongji Hospital, The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China, Bethune Charitable Foundation
- Study start
- 6 Jun 2022 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 9 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rhTPO | Experimental | Drug: rhTPOThe study in a 2:1 randomization ratio (110 subjects to rhTPO). |
| Control | Other | Drug: ControlThe study in a 2:1 randomization ratio (55 subjects to control group). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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:
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rhTPOAlso: Recombinant human thrombopoietin, TPIAOrhTPO 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. | Drug | rhTPO |
| ControlAlso: No interventionNon-rhTPO treatment | Drug | Control |
Primary outcome
Proportion of patients whose platelet count is ≥ 75×10^9/L after 2 cycles cancer treatment.
Time frame: After 2 cycles cancer treatment (month 1.5~month 2, depends on chemotherapy regimen), each cycle is 14, 21 or 28 days
Efficacy was defined as treatment without salvage therapy to increase platelet counts.
6 secondary outcomes
Proportion of patients receiving salvage treatment to increase platelet counts.
Time frame: during 3 cycles cancer treatment period(each cycle is 14, 21 or 28 days)
Changes in cTnT/cTnI
Time frame: 1 and 3 months after initial treatment
Changes in NT-proBNP
Time frame: 1 and 3 months after initial treatment
Changes in LVEF
Time frame: 1 and 3 months after initial treatment
Changes in neutrophile granulocyte count
Time frame: during 3 cycles cancer treatment period(each cycle is 14, 21 or 28 days)
Incidence of adverse events
Time frame: from study start date to the end of follow-up, up to 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- Individual participant dataSharing planned: Yes. Researchers qualified can request the dataset, including de-identified individual subject data. Data may be requested from PI from 12 months 36 months after study completion.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yunlong Xia, MD,PhD principal investigator
The First Affiliated Hospital of Dalian Medical University
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing rhTPO in people with Cancer Treatment Induced Thrombocytopenia, run by The First Affiliated Hospital of Dalian Medical University at 15 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiwei Liu, MD (18098877966, jiweiliudl@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients whose platelet count is ≥ 75×10^9/L after 2 cycles cancer treatment. (time frame: After 2 cycles cancer treatment (month 1.5~month 2, depends on chemotherapy regimen), each cycle is 14, 21 or 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2024.