ThrombocytopoietinPhase 1/2NCT03014102
Recombinant Human Thrombopoietin for Mobilization of Peripheral Blood Progenitor Cells for Autologous Transplantation
A Phase 1/2 study testing Recombinant Human Thrombopoietin in people with Thrombocytopoietin and Hematopoietic Stem Cell Mobilization, run by Hongnan Mo at 1 site in China.
Trial summary
The purpose of this study is to determine whether recombinant human thrombopoietin are effective in peripheral blood progenitor cells mobilization for autologous transplantation. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Thrombocytopoietin, Hematopoietic Stem Cell Mobilization, Hematopoietic Stem Cell Transplantation
- What is being tested?
- Recombinant Human Thrombopoietin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Jun 2016to Sep 2020
- Phase
- Phase 1/2
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- a histologically confirmed diagnosis of Hodgkin's disease, non-Hodgkin's lymphoma, or selected high-risk solid tumors that are planned to receive autologous peripheral blood progenitor cell transplantation
- Eastern Cooperative Oncology Group performance status of 0 - 2.
Who cannot join
- abnormal liver function (aminotransferase or bilirubin levels 2 times upper limit of normal), leukopenia (white blood cell count 3000/L), or a history of platelet or other disorders associated with a bleeding diathesis
- a history of thromboembolic disease, coronary heart disease,stroke, arrhythmias, central nervous system metastases,or other organ system diseases or abnormalities that might predispose individuals to treatment-related complications
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Hongnan Mo, MD, 8610-87788103, mhnzlyynk@outlook.com
About this study
The purpose of this study is to determine whether recombinant human thrombopoietin are effective in peripheral blood progenitor cells mobilization for autologous transplantation.
- Conditions
- Thrombocytopoietin, Hematopoietic Stem Cell Mobilization, Hematopoietic Stem Cell Transplantation
- Being tested
- Recombinant Human Thrombopoietin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Human ThrombopoietinDrug
Recombinant human Thrombopoietin is a full length glycosylated molecule identical to endogenous Thrombopoietin.
| Study group | Role | What they receive |
|---|---|---|
| TPOqd | Experimental | Recombinant Human Thrombopoietin 300U/kg/d ih quaque die, day-3/-2/-1 before mobilization Receives: Drug: Recombinant Human Thrombopoietin |
| TPOqod | Active comparator | Recombinant Human Thrombopoietin 300U/kg/d ih qua altera die, day-3/-1/+2 before mobilization Receives: Drug: Recombinant Human Thrombopoietin |
What is being measured
The primary outcome is the main question the study is designed to answer.
the average number of cluster of differentiation 34 positive cells/kg
To evaluate the effect of combining various treatment schedules of recombinant human thrombopoietin with granulocyte colony stimulating factor on the mobilization of peripheral blood progenitor cells.
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2017 (estimated)
- Study startJun 2016
- Primary completionSep 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ThrombocytopoietinStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hongnan Mo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hongnan Mo, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03014102
- Sponsor's protocol ID
- LC2016B03
- Status last verified
- Dec 2019
- First submitted
- 5 Jan 2017
- Last updated
- 6 Dec 2019
- Results posted
- No
Publications
Mo H, Liu P, Qin Y, He X, Han X, Yao J, Su W, Zhang S, Tang L, Zhao F, Gui L, Yang S, Yang J, Zhou S, Zhang Z, Shi Y. Recombinant human thrombopoietin prior to mobilization chemotherapy facilitates platelet recovery in autologous transplantation in patients with lymphoma: Results of a prospective randomized study. Chronic Dis Transl Med. 2021 Jun 24;7(3):190-198. doi: 10.1016/j.cdtm.2021.05.003. eCollection 2021 Sep.
PubMed 34505019
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recombinant Human Thrombopoietin for Mobilization of Peripheral Blood Progenitor Cells for Autologous Transplantation
- ClinicalTrials.gov ID
- NCT03014102
- Acronym / sponsor ID
- LC2016B03
- Conditions
- Thrombocytopoietin, Hematopoietic Stem Cell Mobilization, Hematopoietic Stem Cell Transplantation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hongnan MoUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 9 Jan 2017 (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.
The purpose of this study is to determine whether recombinant human thrombopoietin are effective in peripheral blood progenitor cells mobilization for autologous transplantation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TPOqd | Experimental | Drug: Recombinant Human ThrombopoietinRecombinant Human Thrombopoietin 300U/kg/d ih quaque die, day-3/-2/-1 before mobilization |
| TPOqod | Active comparator | Drug: Recombinant Human ThrombopoietinRecombinant Human Thrombopoietin 300U/kg/d ih qua altera die, day-3/-1/+2 before mobilization |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- a histologically confirmed diagnosis of Hodgkin's disease, non-Hodgkin's lymphoma, or selected high-risk solid tumors that are planned to receive autologous peripheral blood progenitor cell transplantation
- Eastern Cooperative Oncology Group performance status of 0 - 2.
Key exclusion criteria (2 listed)
- abnormal liver function (aminotransferase or bilirubin levels 2 times upper limit of normal), leukopenia (white blood cell count 3000/L), or a history of platelet or other disorders associated with a bleeding diathesis
- a history of thromboembolic disease, coronary heart disease,stroke, arrhythmias, central nervous system metastases,or other organ system diseases or abnormalities that might predispose individuals to treatment-related complications
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 ThrombopoietinRecombinant human Thrombopoietin is a full length glycosylated molecule identical to endogenous Thrombopoietin. | Drug | TPOqd, TPOqod |
Primary outcome
the average number of cluster of differentiation 34 positive cells/kg
Time frame: up to 24 months
To evaluate the effect of combining various treatment schedules of recombinant human thrombopoietin with granulocyte colony stimulating factor on the mobilization of peripheral blood progenitor cells.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2019.
- Derived from this study: PubMed 34505019Mo H, Liu P, Qin Y, He X, Han X, Yao J, Su W, Zhang S, Tang L, Zhao F, Gui L, Yang S, Yang J, Zhou S, Zhang Z, Shi Y. Recombinant human thrombopoietin prior to mobilization chemotherapy facilitates platelet recovery in autologous transplantation in patients with lymphoma: Results of a prospective randomized study. Chronic Dis Transl Med. 2021 Jun 24;7(3):190-198. doi: 10.1016/j.cdtm.2021.05.003. eCollection 2021 Sep.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Recombinant Human Thrombopoietin in people with Thrombocytopoietin and Hematopoietic Stem Cell Mobilization, run by Hongnan Mo 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 2 inclusion and 2 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 6 Dec 2019. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hongnan Mo, MD (8610-87787451, mhnzlyynk@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the average number of cluster of differentiation 34 positive cells/kg (time frame: up to 24 months). 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 NCT03014102, which also lists 1 linked publication.
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 6 Dec 2019; AzTrials last refreshed its copy on 7 Nov 2026.