ThrombocytopeniaPhase 4NCT02267993
Efficacy and Safety of rhTPO for the Treatment of Thrombocytopenia After Chemotherapy in AML Patients
A Phase 4 study testing recombinant human thrombopoietin in people with Thrombocytopenia, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
In this single-center, randomized, open-label, crossover, prospective clinical trial, a total of 120 AML patients who achieved remission will be randomized into two groups, of 60 cases in each group. Each subject is required to undergo two cycles of chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Thrombocytopenia
- What is being tested?
- recombinant human thrombopoietin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteChina
- Study dates
- Oct 2014to 31 Aug 2018
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age of 18-55 years;
- Patients that meet the diagnostic criteria of acute myeloid leukemia (except M3 and M7 subtypes), and achieve complete remission following induction chemotherapy and undergo consolidation therapy;
- Patients who require two successive cycles of DA (Ara-c 1.5 g/m2/q12 h and DNR 40 mg/m2/d on days 1-3) or MA regimen (Ara-C 1.5 g/m2/q12 h and MTZ 6 mg/m2/d on days 1-3) at the phase of consolidation therapy, or underwent consolidation therapy with administration of Ara-C 3 g/m2/q12 h alone, with dose adjustment of less than 10% Ara-C dose;
- Patients with the minimum platelet count of < 30´109/L at the final cycle of chemotherapy during the induction stage;
- Patients without apparent liver or renal dysfunctions (serum levels of urea nitrogen, creatinine, aminotransferase and bilirubin were all ≤ 1.5 times of the normal upper limit);
- Patients without severe heart or lung dysfunctions;
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- Patients with life expectancy of > 12 weeks;
- Patients with ECOG score of ≤ 2;
- Patients are willing to participate in the study and sign the informed consent.
Who cannot join
- Patients with a medical history of severe allergy to biologics;
- Patients with thromboembolic or hemorrhagic disease, or a recent medical history of thrombosis;
- Patients with a history of mental disorders;
- Pregnant or lactating patients, or patients with failure in use of contraception during the study period;
- Patients with M3 or M7 subtype;
- Patients with a platelet count of 1000 ´109/L at the start of the study;
- Patients with other factors which were considered not to be suitable to participate in the study by the investigators.
Trial locations and contacts
1 site in 1 country.
China1 site
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, 300020
About this study
Official title: A Clinical Trial to Evaluate the Efficacy and Safety of Recombinant Human Thrombopoietin in the Treatment of Thrombocytopenia After Chemotherapy in Acute Myeloid Leukemia
In this single-center, randomized, open-label, crossover, prospective clinical trial, a total of 120 AML patients who achieved remission will be randomized into two groups, of 60 cases in each group. Each subject is required to undergo two cycles of chemotherapy. At the treatment cycle, patients received subcutaneous injection of rhTPO. At the control cycle, rhTPO therapy is not given.The safety of rhTPO is evaluated by the monitoring of liver and renal functions, blood coagulation, and TPO-neutralizing antibody, and adverse events associated with rhTPO treatment are recorded during the study period.
Read the detailed description
In this single-center, randomized, open-label, crossover, prospective clinical trial, a total of 120 AML patients who achieved remission following induction chemotherapy will be recruited and randomized into two groups, of 60 cases in each group. For one group, the treatment cycle is in the first chemotherapy cycle and the control cycle is in the second one. For another group, the treatment cycle is in the second chemotherapy cycle and the control cycle is in the first one.
Each subject is required to undergo two cycles of chemotherapy. At the treatment cycle, patients received subcutaneous injection of rhTPO at a dose of 300 U/kg body weight once daily at a platelet count of < 50×109/L, and rhTPO treatment ceased at a platelet count of ≥20×109/L if platelet is not transfused. At the control cycle, rhTPO therapy is not given.
Each subject is required to be followed up for successive two chemotherapy cycles following inclusion in this study. During the follow-up period, routine blood test is performed once every other day, and platelet transfusion is recorded.
The safety of rhTPO is evaluated by the monitoring of liver and renal functions, blood coagulation, and TPO-neutralizing antibody, and adverse events associated with rhTPO treatment are recorded during the study period.
- Conditions
- Thrombocytopenia
- Being tested
- recombinant human thrombopoietin
- Medical subject headings
- Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recombinant human thrombopoietinDrug
Also called rhTPO
Patients received subcutaneous injection of recombinant human thrombopoietin at a dose of 300 U/kg body weight once daily at a platelet count of < 50×109/L, and recombinant human thrombopoietin treatment ceased at a platelet count of ≥20×109/L if platelet is not transfused.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | At the first chemotherapy cycle (treatment cycle), patients receive recombinant human thrombopoietin treatment. At the second chemotherapy cycle (control cycle), recombinant human thrombopoietin therapy is not given. Receives: Drug: recombinant human thrombopoietin |
| Arm B | Experimental | At the first chemotherapy cycle (control cycle), recombinant human thrombopoietin therapy is not given; at the second chemotherapy cycle (treatment cycle), patients receive recombinant human thrombopoietin treatment. Receives: Drug: recombinant human thrombopoietin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of platelet count of < 20 ´ 109/Lat each cycle of chemotherapy.
Measured: From Day1 after chemotherapy up to Day21 after chemotherapy
Secondary outcomes (5)
Time and dose of platelet transfusion at each cycle of chemotherapy
Measured: From Day1 after chemotherapy up to Day21 after chemotherapy
The minimum platelet count at each cycle of chemotherapy
Measured: From Day1 after chemotherapy up to Day21 after chemotherapy
Duration from the minimum platelet count to ≥ 20´109/L at each cycle of chemotherapy according to CTCAE(v4.0)
Measured: From Day1 after chemotherapy up to Day21 after chemotherapy
Number and grade of bleeding Adverse Events at each cycle of chemotherapy
Measured: From Day1 after chemotherapy up to Day21 after chemotherapy
Duration of hospital stay (from the first day of chemotherapy to discharge from hospital) at each cycle of chemotherapy
Measured: From Day1 after chemotherapy up to Day21 after chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2014 (estimated)
- Study startOct 2014
- Primary completion1 Aug 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jianxiang Wang, Dr, Principal investigator, Institute of Hematology & Blood Diseases Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02267993
- Sponsor's protocol ID
- IIT2014010
- Status last verified
- Mar 2020
- First submitted
- 9 Oct 2014
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Evaluate the Efficacy and Safety of Recombinant Human Thrombopoietin in the Treatment of Thrombocytopenia After Chemotherapy in Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT02267993
- Acronym / sponsor ID
- IIT2014010
- Conditions
- Thrombocytopenia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- Oct 2014 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 20 Oct 2014 (estimated)
- 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.
In this single-center, randomized, open-label, crossover, prospective clinical trial, a total of 120 AML patients who achieved remission will be randomized into two groups, of 60 cases in each group. Each subject is required to undergo two cycles of chemotherapy. At the treatment cycle, patients received subcutaneous injection of rhTPO. At the control cycle, rhTPO therapy is not given.The safety of rhTPO is evaluated by the monitoring of liver and renal functions, blood coagulation, and TPO-neutralizing antibody, and adverse events associated with rhTPO treatment are recorded during the study period.
Detailed description
In this single-center, randomized, open-label, crossover, prospective clinical trial, a total of 120 AML patients who achieved remission following induction chemotherapy will be recruited and randomized into two groups, of 60 cases in each group. For one group, the treatment cycle is in the first chemotherapy cycle and the control cycle is in the second one. For another group, the treatment cycle is in the second chemotherapy cycle and the control cycle is in the first one.
Each subject is required to undergo two cycles of chemotherapy. At the treatment cycle, patients received subcutaneous injection of rhTPO at a dose of 300 U/kg body weight once daily at a platelet count of < 50×109/L, and rhTPO treatment ceased at a platelet count of ≥20×109/L if platelet is not transfused. At the control cycle, rhTPO therapy is not given.
Each subject is required to be followed up for successive two chemotherapy cycles following inclusion in this study. During the follow-up period, routine blood test is performed once every other day, and platelet transfusion is recorded.
The safety of rhTPO is evaluated by the monitoring of liver and renal functions, blood coagulation, and TPO-neutralizing antibody, and adverse events associated with rhTPO treatment are recorded during the study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: recombinant human thrombopoietinAt the first chemotherapy cycle (treatment cycle), patients receive recombinant human thrombopoietin treatment. At the second chemotherapy cycle (control cycle), recombinant human thrombopoietin therapy is not given. |
| Arm B | Experimental | Drug: recombinant human thrombopoietinAt the first chemotherapy cycle (control cycle), recombinant human thrombopoietin therapy is not given; at the second chemotherapy cycle (treatment cycle), patients receive recombinant human thrombopoietin treatment. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Age of 18-55 years;
- Patients that meet the diagnostic criteria of acute myeloid leukemia (except M3 and M7 subtypes), and achieve complete remission following induction chemotherapy and undergo consolidation therapy;
- Patients who require two successive cycles of DA (Ara-c 1.5 g/m2/q12 h and DNR 40 mg/m2/d on days 1-3) or MA regimen (Ara-C 1.5 g/m2/q12 h and MTZ 6 mg/m2/d on days 1-3) at the phase of consolidation therapy, or underwent consolidation therapy with administration of Ara-C 3 g/m2/q12 h alone, with dose adjustment of less than 10% Ara-C dose;
- Patients with the minimum platelet count of < 30´109/L at the final cycle of chemotherapy during the induction stage;
- Patients without apparent liver or renal dysfunctions (serum levels of urea nitrogen, creatinine, aminotransferase and bilirubin were all ≤ 1.5 times of the normal upper limit);
Key exclusion criteria (7 listed)
- Patients with a medical history of severe allergy to biologics;
- Patients with thromboembolic or hemorrhagic disease, or a recent medical history of thrombosis;
- Patients with a history of mental disorders;
- Pregnant or lactating patients, or patients with failure in use of contraception during the study period;
- Patients with M3 or M7 subtype;
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 thrombopoietinAlso: rhTPOPatients received subcutaneous injection of recombinant human thrombopoietin at a dose of 300 U/kg body weight once daily at a platelet count of < 50×109/L, and recombinant human thrombopoietin treatment ceased at a platelet count of ≥20×109/L if platelet is not transfused. | Drug | Arm A, Arm B |
Primary outcome
Duration of platelet count of < 20 ´ 109/Lat each cycle of chemotherapy.
Time frame: From Day1 after chemotherapy up to Day21 after chemotherapy
5 secondary outcomes
Time and dose of platelet transfusion at each cycle of chemotherapy
Time frame: From Day1 after chemotherapy up to Day21 after chemotherapy
The minimum platelet count at each cycle of chemotherapy
Time frame: From Day1 after chemotherapy up to Day21 after chemotherapy
Duration from the minimum platelet count to ≥ 20´109/L at each cycle of chemotherapy according to CTCAE(v4.0)
Time frame: From Day1 after chemotherapy up to Day21 after chemotherapy
Number and grade of bleeding Adverse Events at each cycle of chemotherapy
Time frame: From Day1 after chemotherapy up to Day21 after chemotherapy
Duration of hospital stay (from the first day of chemotherapy to discharge from hospital) at each cycle of chemotherapy
Time frame: From Day1 after chemotherapy up to Day21 after chemotherapy
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 30 May 2025.
- Individual participant dataSharing planned: No
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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.
Jianxiang Wang, Dr principal investigator
Institute of Hematology & Blood Diseases Hospital, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing recombinant human thrombopoietin in people with Thrombocytopenia, 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 9 inclusion and 7 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 30 May 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 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?
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?
Duration of platelet count of < 20 ´ 109/Lat each cycle of chemotherapy. (time frame: From Day1 after chemotherapy up to Day21 after chemotherapy). 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 30 May 2025.