Chemotherapy-induced ThrombocytopeniaNCT05688306
To Evaluate Thrombosis Risk in Chemotherapy Patients With Solid Tumors Who Receiving Thrombocytopenia Treatment
An observational study of Chemotherapy-induced Thrombocytopenia, run by Liaoning Cancer Hospital & Institute at 1 site in China.
Trial summary
Chemotherapy-induced thrombocytopenia (CIT) is a common hematological toxicity in patients with solid tumors undergo chemotherapy, which can increase the risk of bleeding, prolong hospital stay, increase medical costs, and even lead to death in severe cases. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chemotherapy-induced Thrombocytopenia
- What is being tested?
- Recombinant Human Interleukin-11 for Injection
- Type of treatment
- Injection or infusion
- How many people
- 3,494 participants
- Where
- 1 siteChina
- Study dates
- 2 Sep 2020to 16 May 2022
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with pathological diagnosis of solid tumors or lymphomas
Who may be able to join
- Patients with pathological diagnosis of solid tumors or lymphomas.
- Have received chemotherapy.
- Diagnosed of CIT.
- Continuous use of platelet raising drugs for at least 5 days.
Who cannot join
- Thrombocytopenia caused other than chemotherapy, including but not limited to: traditional Chinese medicine, congenital platelet disease, etc.
- The basic value of platelet count is continuously higher than 300×10^9/L.
- Those without blood routine or coagulation function data.
- Those who received non-chemotherapy drugs that may cause thrombocytopenia, such as sulfonamides.
- Pseudothrombocytopenia due to Ethylenediamine tetraacetic acid (EDTA) as an anticoagulant in test samples.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Real World Observational Study to Evaluate Thrombosis Risk in Chemotherapy Patients With Solid Tumors Who Receiving Platelet-raising Therapy
Chemotherapy-induced thrombocytopenia (CIT) is a common hematological toxicity in patients with solid tumors undergo chemotherapy, which can increase the risk of bleeding, prolong hospital stay, increase medical costs, and even lead to death in severe cases. The incidence and severity of CIT varies among different chemotherapy regimens. Recombinant human interleukin-11 (rhIL-11) and recombinant human thrombopoietin (rhTPO) have been approved for the treatment of chemotherapy-induced thrombocytopenia.
Tumor patients are at high risk for venous thromboembolism (VTE). In the clinical study of rhIL-11, it was found that the administration of rhIL-11 in healthy subjects caused an increase in the plasma concentration of vWF factor in the form of normal mults. The application of rhIL-11 in patients with myeloid leukemia can increase the concentration of α2 globulin, fibrinogen and prothrombin time. However, there have been no large-scale clinical studies at home and abroad to evaluate whether platelet raising therapy will increase the risk of thrombosis in chemotherapy patients with solid tumor. This study is aimed to evaluate the efficacy and safety of platelet upwelling therapy in patients with solid tumors undergoing chemotherapy.
- Conditions
- Chemotherapy-induced Thrombocytopenia
- Being tested
- Recombinant Human Interleukin-11 for Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Human Interleukin-11 for InjectionDrug
Also called rhIL-11
received rhIL-11 injection for at least 5 consecutive days
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the incidence of thrombosis.
Measured: 1 month after treatment.
Secondary outcomes (3)
To evaluate the absolute count of platelets.
Measured: 1 month after treatment.
To evaluate the level D-dimer.
Measured: 1 month after treatment.
To examine the coagulation function index.
Measured: 1 month after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start2 Sep 2020
- Primary completion16 May 2022
- Study completion16 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,494 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liaoning Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaojing Xing, Principal investigator, Liaoning Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05688306
- Sponsor's protocol ID
- IL-11xs
- Status last verified
- Dec 2022
- First submitted
- 2 Dec 2022
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real World Observational Study to Evaluate Thrombosis Risk in Chemotherapy Patients With Solid Tumors Who Receiving Platelet-raising Therapy
- ClinicalTrials.gov ID
- NCT05688306
- Acronym / sponsor ID
- IL-11xs
- Conditions
- Chemotherapy-induced Thrombocytopenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,494 participants (actual)
- Lead sponsor
- Liaoning Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 2 Sep 2020 (actual)
- Primary completion
- 16 May 2022 (actual)
- Study completion
- 16 May 2022 (actual)
- First posted
- 18 Jan 2023 (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.
Chemotherapy-induced thrombocytopenia (CIT) is a common hematological toxicity in patients with solid tumors undergo chemotherapy, which can increase the risk of bleeding, prolong hospital stay, increase medical costs, and even lead to death in severe cases. The incidence and severity of CIT varies among different chemotherapy regimens. Recombinant human interleukin-11 (rhIL-11) and recombinant human thrombopoietin (rhTPO) have been approved for the treatment of chemotherapy-induced thrombocytopenia.
Tumor patients are at high risk for venous thromboembolism (VTE). In the clinical study of rhIL-11, it was found that the administration of rhIL-11 in healthy subjects caused an increase in the plasma concentration of vWF factor in the form of normal mults. The application of rhIL-11 in patients with myeloid leukemia can increase the concentration of α2 globulin, fibrinogen and prothrombin time. However, there have been no large-scale clinical studies at home and abroad to evaluate whether platelet raising therapy will increase the risk of thrombosis in chemotherapy patients with solid tumor. This study is aimed to evaluate the efficacy and safety of platelet upwelling therapy in patients with solid tumors undergoing chemotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with pathological diagnosis of solid tumors or lymphomas
Key inclusion criteria (4 listed)
- Patients with pathological diagnosis of solid tumors or lymphomas.
- Have received chemotherapy.
- Diagnosed of CIT.
- Continuous use of platelet raising drugs for at least 5 days.
Key exclusion criteria (5 listed)
- Thrombocytopenia caused other than chemotherapy, including but not limited to: traditional Chinese medicine, congenital platelet disease, etc.
- The basic value of platelet count is continuously higher than 300×10^9/L.
- Those without blood routine or coagulation function data.
- Those who received non-chemotherapy drugs that may cause thrombocytopenia, such as sulfonamides.
- Pseudothrombocytopenia due to Ethylenediamine tetraacetic acid (EDTA) as an anticoagulant in test samples.
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 |
|---|---|---|
| Recombinant Human Interleukin-11 for InjectionAlso: rhIL-11received rhIL-11 injection for at least 5 consecutive days | Drug | – |
Primary outcome
To assess the incidence of thrombosis.
Time frame: 1 month after treatment.
3 secondary outcomes
To evaluate the absolute count of platelets.
Time frame: 1 month after treatment.
To evaluate the level D-dimer.
Time frame: 1 month after treatment.
To examine the coagulation function index.
Time frame: 1 month after treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- Individual participant dataSharing planned: No
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Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects With Non-small Cell Lung Cancer (NSCLC), Ovarian Cancer, or Breast Cancer
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A Study to Evaluate the Efficacy and Safety of Hetrombopag Olamine Tablets Vs Placebo in Patients With Chemotherapy-Induced Thrombocytopenia (ExCIT)
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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.
Xiaojing Xing principal investigator
Liaoning Cancer Hospital & Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chemotherapy-induced Thrombocytopenia, run by Liaoning Cancer Hospital & Institute at 1 site 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 18 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the incidence of thrombosis. (time frame: 1 month after treatment.). 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 18 Jan 2023.