Antineoplastic Adverse ReactionPhase 3NCT02244658
Recombinant Human Thrombopoietin (rhTPO) in Management of Chemotherapy-induced Thrombocytopenia in Acute Myelocytic Leukemia
A Phase 3 study testing rhTPO in people with Antineoplastic Adverse Reaction and Thrombocytopenia, run by Shandong University at 1 site in China.
Trial summary
Chemotherapy-related myelosuppression usually occurs in AML patients, which induces severe thrombocytopenia and haemorrhage, a leading cause of death. This clinical trial aims at evaluating efficacy and safety of rhTPO in management of chemotherapy-induced thrombocytopenia in acute myelocytic leukemia. Read more about this study
- Who is it for?
- Ages 15 to 75 years
- Conditions the study is for
- Antineoplastic Adverse Reaction, Thrombocytopenia, Acute Myelocytic Leukemia
- 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
- 80 participants
- Where
- 1 siteChina
- Study dates
- Sep 2014to Aug 2017
- Phase
- Phase 3
- 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 15 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- AML patients with PLT count <30×10^9/L during the previous cycle of chemotherapy to minimize the risk of clinically significant bleeding.
Who cannot join
- allergic history to biological agents; history of thrombotic or hemorrhagic diseases; M3 or M7 subtype; pregnancy; hypertension; cardiovascular disease; diabetes; liver and kidney function impairment;
Trial locations and contacts
1 site in 1 country.
Ming Hou contact
China1 site, 1 recruiting
- Recruiting
Qilu hospital, Shandong University
Jinan, Shandong, 250012
Ming Hou, houming@medmail.com.cn
Ming Hou
About this study
Official title: Recombinant Human Thrombopoietin (rhTPO) in Management of Chemotherapy-induced Thrombocytopenia in Acute Myelocytic Leukemia: a Multicenter Clinical Trial
Chemotherapy-related myelosuppression usually occurs in AML patients, which induces severe thrombocytopenia and haemorrhage, a leading cause of death. This clinical trial aims at evaluating efficacy and safety of rhTPO in management of chemotherapy-induced thrombocytopenia in acute myelocytic leukemia.
Read the detailed description
The investigators are undertaking a parallel group, multicentre, randomized controlled trial of 80 adults with chemotherapy-induced thrombocytopenia from 8 medical centers in China. AML patients with PLT count <30×10^9/L during the previous cycle of chemotherapy are randomized into two groups that one receives rhTPO at 1.0μg/kg·d subcutaneously for 7~14 consecutive days and the other receives no rhTPO or other thrombopoietic factor. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study.
- Being tested
- rhTPO
- Keywords
- chemotherapy-induced thrombocytopenia, recombinant human thrombopoietin, acute myelocytic leukemia
- Medical subject headings
- Thrombocytopenia, Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rhTPODrug
Also called TPIAO, S20050048/49 (SFDA, China)
rhTPO 1.0 μg/kg·d subcutaneously for 7~14 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| rhTPO | Experimental | rhTPO 1.0 μg/kg·d subcutaneously for 7~14 consecutive days Receives: Drug: rhTPO |
| control | No intervention | no thrombopoietic agents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of platelet response
days that PLT count rebound to 30×10^9/L, 50×10^9/L and 100×10^9/L, respectively, from the minimal level after the very cycle of chemotherapy.
Measured: 21 days since the first administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionJun 2017 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antineoplastic Adverse ReactionStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ming Hou, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02244658
- Sponsor's protocol ID
- RhTPO-AML thrombocytopenia
- Status last verified
- Mar 2016
- First submitted
- 13 Sep 2014
- Last updated
- 20 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recombinant Human Thrombopoietin (rhTPO) in Management of Chemotherapy-induced Thrombocytopenia in Acute Myelocytic Leukemia: a Multicenter Clinical Trial
- ClinicalTrials.gov ID
- NCT02244658
- Acronym / sponsor ID
- RhTPO-AML thrombocytopenia
- Keywords
- chemotherapy-induced thrombocytopenia, recombinant human thrombopoietin, acute myelocytic leukemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 19 Sep 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.
Chemotherapy-related myelosuppression usually occurs in AML patients, which induces severe thrombocytopenia and haemorrhage, a leading cause of death. This clinical trial aims at evaluating efficacy and safety of rhTPO in management of chemotherapy-induced thrombocytopenia in acute myelocytic leukemia.
Detailed description
The investigators are undertaking a parallel group, multicentre, randomized controlled trial of 80 adults with chemotherapy-induced thrombocytopenia from 8 medical centers in China. AML patients with PLT count <30×10^9/L during the previous cycle of chemotherapy are randomized into two groups that one receives rhTPO at 1.0μg/kg·d subcutaneously for 7~14 consecutive days and the other receives no rhTPO or other thrombopoietic factor. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study.
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: rhTPOrhTPO 1.0 μg/kg·d subcutaneously for 7~14 consecutive days |
| control | No intervention | –no thrombopoietic agents |
Who may qualify
- Ages
- 15 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- AML patients with PLT count <30×10^9/L during the previous cycle of chemotherapy to minimize the risk of clinically significant bleeding.
Key exclusion criteria (1 listed)
- allergic history to biological agents; history of thrombotic or hemorrhagic diseases; M3 or M7 subtype; pregnancy; hypertension; cardiovascular disease; diabetes; liver and kidney function impairment;
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: TPIAO, S20050048/49 (SFDA, China)rhTPO 1.0 μg/kg·d subcutaneously for 7~14 consecutive days | Drug | rhTPO |
Primary outcome
Evaluation of platelet response
Time frame: 21 days since the first administration
days that PLT count rebound to 30×10^9/L, 50×10^9/L and 100×10^9/L, respectively, from the minimal level after the very cycle of chemotherapy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2016.
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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.
Ming Hou contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing rhTPO in people with Antineoplastic Adverse Reaction and Thrombocytopenia, run by Shandong University 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 1 inclusion and 1 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 20 Apr 2016. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Ming Hou (houming@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of platelet response (time frame: 21 days since the first administration). 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 20 Apr 2016.