Chemotherapy-induced ThrombocytopeniaPhase 2NCT04600960
Eltrombopag for Chemotherapy-induced Thrombocytopenia
A Phase 2 study testing Eltrombopag in people with Chemotherapy-induced Thrombocytopenia and Eltrombopag, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
To evaluate the efficacy and safety of eltrombopag to treat chemotherapy-induced thrombocytopenia in solid tumors Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-induced Thrombocytopenia, Eltrombopag
- What is being tested?
- Eltrombopag
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2020to 31 Dec 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥18 years old, male or female;
- Conform to the diagnostic criteria of chemotherapy-induced thrombocytopenia (CIT); Ineffective after repeated treatment with rhTPO or IL-11；
- Stop radiotherapy or chemotherapy for more than 1 month;
- Platelet counts <30 ×10^9/L, and bleeding tendency;
- Estimated survival period ≥ 6 months；
- People who are willing to sign the informed consent voluntarily and follow the research program.
- Liver and kidney function<1.5×upper limit of normal, qualified for physical examination；
- Subject is practicing an acceptable method of contraception. Women of childbearing potential must have a negative serum pregnancy test in the whole study;
Who cannot join
- Those with uncontrollable primary diseases of important organs, such as extensive metastasis of malignant tumors, liver failure, heart failure, kidney failure and other diseases；
- Patients with poor compliance;
- Positive serology for HIV, hepatitis B virus (HBV), hepatitis C virus (HCV), and/or hepatitis D virus (HDV), Syphilis; Positive for Epstein-Barr Virus DNA, Cytomegalovirus DNA;
- Accompanied by extensive and severe bleeding, such as hemoptysis, upper gastrointestinal bleeding, intracranial hemorrhage, etc.
- There is currently a heart disease requiring treatment or a poorly controlled hypertension judged by the investigator；
- Patients with thrombotic diseases such as pulmonary embolism, thrombosis, and atherosclerosis；
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- Those who have received allogeneic stem cell transplantation or organ transplantation in the past；
- Patients with mental disorders who cannot normally obtain informed consent and undergo trials and follow-up；
- Patients whose toxic symptoms caused by treatment before participating in the trial have not disappeared；
- Other serious diseases that may restrict participants from participating in this trial (such as diabetes; severe heart failure; myocardial obstruction or unstable arrhythmia or unstable angina in the past 6 months; gastric ulcers; mobility Autoimmune diseases, etc.)；
- Patients with sepsis or patients with other irregular bleeding；
- Patients taking antiplatelet drugs at the same time；
- Pregnant women, suspected pregnancy (a positive pregnancy test for human chorionic gonadotropin in urine at screening) and breastfeeding patients；
- Pre-existing cardiac disease, including congestive heart failure of New York Heart Association [NYHA] Grade III/IV, arrhythmia requiring treatment or myocardial infarction within the last 6 months. No arrhythmia known to increase the risk of thrombotic events (e.g. atrial fibrillation), or patients with a QT >450msec or QTc > 480 for patients with a Bundle Branch Block;
- Researchers believe that patients should not participate in the test of any other condition.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Chinese Academy of Medical Science and Blood Disease Hospital
Tianjin, Tianjin Municipality, 300020
Yunfei Chen, MD, +86-22-23909009, chenyunfei@ihcams.ac.cn
About this study
Official title: Eltrombopag for Chemotherapy-induced Thrombocytopenia: a Prospective Multi-center One-arm Study in Solid Tumors
To evaluate the efficacy and safety of eltrombopag to treat chemotherapy-induced thrombocytopenia in solid tumors
Read the detailed description
This is a single-arm study to evaluate the safety and efficacy of eltrombopag to treat chemotherapy-induced thrombocytopenia（CIT）. These subjects have been treated with recombinant human thrombopoietin（rhTPO） or interleukin 11（IL-11） before, the platelets can rise to normal or reach the effective standard, but after the re-application, the effective standard is not reached, or the effective standard is still not reached after the rhTPO 300U/kg/d treatment for 14 days. The investigator will assess the changes of the platelet counts after the treatment of eltrombopag from week 1 to week 24, and observe incidence of adverse events during the treatment of eltrombopag.The investigator will complete the 4 weeks safety visits（once a week），if the subjects end or withdraw from the clinical trial.
Patients with chemotherapy-induced thrombocytopenia who had the same inclusion and exclusion criteria in the same period or in the past will be compared with the efficacy and safety of supportive treatment in the same period or history, so as to preliminarily explore and evaluate the efficacy and safety of eltrombopag treatment.
- Conditions
- Chemotherapy-induced Thrombocytopenia, Eltrombopag
- Being tested
- Eltrombopag
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EltrombopagDrug
The subjects will initiate treatment with 75 mg eltrombopag. Platelet counts is obtained weekly and dose adjustment should be done according to platelet counts, and maximum dose should not exceed 75 mg daily. Subjects whose platelet count ≤100×109/L，the eltrombopag dose will maintain. If platelet count >100×109/L for 2 weeks, the subjects need to reduce the dose of eltrombopag to the next lower dose or lower frequency. If subjects whose platelet count exceeds 100×109/L for 4 weeks，already have reduced the dose of eltrombopag to 25mg once every other day during the treatment period, eltrombopag can be stopped for observation, until platelet counts fall below 100×109/L. If the subjects do not need further chemotherapy or radiotherapy, the subjects can taper off eltrombopag if the platelet is greater than 50×109/L.
| Study group | Role | What they receive |
|---|---|---|
| 50 subjects with chemotherapy-induced thrombocytopenia | Experimental | 50 enrolled subjects will be picked up to take eltrombopag at the indicated dose. Receives: Drug: Eltrombopag |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of the platelet counts after the treatment of eltrombopag
The investigator will assess the changes of the platelet counts after the treatment of eltrombopag from week 1 to week 24.
Measured: 24 weeks
Incidence of adverse events after the treatment of eltrombopag
The investigator will observe incidence of adverse events after the treatment of eltrombopag, including thrombosis, diarrhea, skin rash, abnormal liver function and so on.
Measured: 24 weeks
Secondary outcomes (4)
Changes of concentration of TPO in peripheral blood
The investigator will observe the concentration of TPO in peripheral blood before and after the treatment of eltrombopag,if necessary
Measured: 24 weeks
Changes of concentration of TPO antibodies in peripheral blood
The investigator will observe the concentration of antibodies in peripheral blood ,if necessary
Measured: 24 weeks
Changes of concentration of anti-c-Mpl antibodies in peripheral blood
The investigator will observe the concentration of antibodies in peripheral blood ,if necessary
Measured: 24 weeks
Changes of concentration of TPO neutralizing antibodies in peripheral blood
The investigator will observe the concentration of antibodies in peripheral blood ,if necessary
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start31 Dec 2020
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chemotherapy-induced ThrombocytopeniaStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Tianjin Medical University Cancer Institute and Hospital, Tianjin Medical University Second Hospital, Tianjin Third Central Hospital, Tianjin People's Hospital, Henan Cancer Hospital, The Second Affiliated Hospital of Kunming Medical University
- Responsible party
- Sponsor
- Investigators
- Lei Zhanglei, MD, Principal investigator, Chinese Academy of Medical Science and Blood Disease Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04600960
- Sponsor's protocol ID
- IIT2020014（Eltrombopag）
- Status last verified
- Jan 2025
- First submitted
- 19 Oct 2020
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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.
Publications
Winer ES, Safran H, Karaszewska B, Richards DA, Hartner L, Forget F, Ramlau R, Kumar K, Mayer B, Johnson BM, Messam CA, Mostafa Kamel Y. Eltrombopag with gemcitabine-based chemotherapy in patients with advanced solid tumors: a randomized phase I study. Cancer Med. 2015 Jan;4(1):16-26. doi: 10.1002/cam4.326. Epub 2014 Aug 28.
PubMed 25165041Winer ES, Safran H, Karaszewska B, Bauer S, Khan D, Doerfel S, Burgess P, Kalambakas S, Mostafa Kamel Y, Forget F. Eltrombopag for thrombocytopenia in patients with advanced solid tumors receiving gemcitabine-based chemotherapy: a randomized, placebo-controlled phase 2 study. Int J Hematol. 2017 Dec;106(6):765-776. doi: 10.1007/s12185-017-2319-9. Epub 2017 Sep 1.
PubMed 28864871
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eltrombopag for Chemotherapy-induced Thrombocytopenia: a Prospective Multi-center One-arm Study in Solid Tumors
- ClinicalTrials.gov ID
- NCT04600960
- Acronym / sponsor ID
- IIT2020014（Eltrombopag）
- Conditions
- Chemotherapy-induced Thrombocytopenia, Eltrombopag
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Collaborators
- Tianjin Medical University Cancer Institute and Hospital, Tianjin Medical University Second Hospital, Tianjin Third Central Hospital, Tianjin People's Hospital, Henan Cancer Hospital, The Second Affiliated Hospital of Kunming Medical University
- Study start
- 31 Dec 2020 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 23 Oct 2020 (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 evaluate the efficacy and safety of eltrombopag to treat chemotherapy-induced thrombocytopenia in solid tumors
Detailed description
This is a single-arm study to evaluate the safety and efficacy of eltrombopag to treat chemotherapy-induced thrombocytopenia（CIT）. These subjects have been treated with recombinant human thrombopoietin（rhTPO） or interleukin 11（IL-11） before, the platelets can rise to normal or reach the effective standard, but after the re-application, the effective standard is not reached, or the effective standard is still not reached after the rhTPO 300U/kg/d treatment for 14 days. The investigator will assess the changes of the platelet counts after the treatment of eltrombopag from week 1 to week 24, and observe incidence of adverse events during the treatment of eltrombopag.The investigator will complete the 4 weeks safety visits（once a week），if the subjects end or withdraw from the clinical trial.
Patients with chemotherapy-induced thrombocytopenia who had the same inclusion and exclusion criteria in the same period or in the past will be compared with the efficacy and safety of supportive treatment in the same period or history, so as to preliminarily explore and evaluate the efficacy and safety of eltrombopag treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 50 subjects with chemotherapy-induced thrombocytopenia | Experimental | Drug: Eltrombopag50 enrolled subjects will be picked up to take eltrombopag at the indicated dose. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged ≥18 years old, male or female;
- Conform to the diagnostic criteria of chemotherapy-induced thrombocytopenia (CIT); Ineffective after repeated treatment with rhTPO or IL-11；
- Stop radiotherapy or chemotherapy for more than 1 month;
- Platelet counts <30 ×10^9/L, and bleeding tendency;
- Estimated survival period ≥ 6 months；
Key exclusion criteria (15 listed)
- Those with uncontrollable primary diseases of important organs, such as extensive metastasis of malignant tumors, liver failure, heart failure, kidney failure and other diseases；
- Patients with poor compliance;
- Positive serology for HIV, hepatitis B virus (HBV), hepatitis C virus (HCV), and/or hepatitis D virus (HDV), Syphilis; Positive for Epstein-Barr Virus DNA, Cytomegalovirus DNA;
- Accompanied by extensive and severe bleeding, such as hemoptysis, upper gastrointestinal bleeding, intracranial hemorrhage, etc.
- There is currently a heart disease requiring treatment or a poorly controlled hypertension judged by the investigator；
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 |
|---|---|---|
| EltrombopagThe subjects will initiate treatment with 75 mg eltrombopag. Platelet counts is obtained weekly and dose adjustment should be done according to platelet counts, and maximum dose should not exceed 75 mg daily. Subjects whose platelet count ≤100×109/L，the eltrombopag dose will maintain. If platelet count >100×109/L for 2 weeks, the subjects need to reduce the dose of eltrombopag to the next lower dose or lower frequency. If subjects whose platelet count exceeds 100×109/L for 4 weeks，already have reduced the dose of eltrombopag to 25mg once every other day during the treatment period, eltrombopag can be stopped for observation, until platelet counts fall below 100×109/L. If the subjects do not need further chemotherapy or radiotherapy, the subjects can taper off eltrombopag if the platelet is greater than 50×109/L. | Drug | 50 subjects with chemotherapy-induced thrombocytopenia |
Primary outcome
Changes of the platelet counts after the treatment of eltrombopag
Time frame: 24 weeks
The investigator will assess the changes of the platelet counts after the treatment of eltrombopag from week 1 to week 24.
Incidence of adverse events after the treatment of eltrombopag
Time frame: 24 weeks
The investigator will observe incidence of adverse events after the treatment of eltrombopag, including thrombosis, diarrhea, skin rash, abnormal liver function and so on.
4 secondary outcomes
Changes of concentration of TPO in peripheral blood
Time frame: 24 weeks
Changes of concentration of TPO antibodies in peripheral blood
Time frame: 24 weeks
Changes of concentration of anti-c-Mpl antibodies in peripheral blood
Time frame: 24 weeks
Changes of concentration of TPO neutralizing antibodies in peripheral blood
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Background: PubMed 25165041Winer ES, Safran H, Karaszewska B, Richards DA, Hartner L, Forget F, Ramlau R, Kumar K, Mayer B, Johnson BM, Messam CA, Mostafa Kamel Y. Eltrombopag with gemcitabine-based chemotherapy in patients with advanced solid tumors: a randomized phase I study. Cancer Med. 2015 Jan;4(1):16-26. doi: 10.1002/cam4.326. Epub 2014 Aug 28.
- Background: PubMed 28864871Winer ES, Safran H, Karaszewska B, Bauer S, Khan D, Doerfel S, Burgess P, Kalambakas S, Mostafa Kamel Y, Forget F. Eltrombopag for thrombocytopenia in patients with advanced solid tumors receiving gemcitabine-based chemotherapy: a randomized, placebo-controlled phase 2 study. Int J Hematol. 2017 Dec;106(6):765-776. doi: 10.1007/s12185-017-2319-9. Epub 2017 Sep 1.
- 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.
Lei Zhanglei, MD principal investigator
Chinese Academy of Medical Science and Blood Disease Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Eltrombopag in people with Chemotherapy-induced Thrombocytopenia and Eltrombopag, run by Institute of Hematology & Blood Diseases Hospital, China 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 8 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 24 Feb 2025. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yunfei Chen, MD (+86-22-23909009, chenyunfei@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of the platelet counts after the treatment of eltrombopag (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04600960, which also lists 2 linked publications.
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 24 Feb 2025.