Hematopoietic Stem Cell MobilizationNCT06955858
Clinical Study of rhTPO in Hematopoietic Stem Cell Mobilization for Autologous Transplantation in Acute Leukemia
A study testing Recombinant Human Thrombopoietin（rhTPO） in people with Hematopoietic Stem Cell Mobilization, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
Evaluation of the efficacy and safety of recombinant human thrombopoietin (rhTPO) at 300 U/kg/day for hematopoietic stem cell mobilization in autologous transplantation among acute leukemia patients Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hematopoietic Stem Cell Mobilization
- What is being tested?
- Recombinant Human Thrombopoietin（rhTPO）
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 30 May 2025to 30 Dec 2026
- Phase
- Interventional
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18～65 years, regardless of gender.
- Histopathologically confirmed acute leukemia with immunohistochemical validation
- Sustained complete hematologic remission with documented minimal residual disease (MRD) negativity.
- Eastern Cooperative Oncology Group (ECOG) performance status smaller than 2 and a life expectancy of more than 6 months
- No active infectious disease; no severe organ failure.
- Willingness to participate with written informed consent for study enrollment.
Who cannot join
- Liver dysfunction (alanine aminotransferase or bilirubin greater than two times the normal upper limit).
- Renal dysfunction (creatinine or urea higher than 1.5 times the normal upper limit).
- Any disease that could put patients at high risk, including but not limited to unstable cardiac disease, uncontrolled atrial fibrillation or hypertension, severe diabetic retinopathy
- rhTPO aller- gies.
- Severe prior thrombosis-event.
- History of other malignancy, unless cured for more than 3 years
Show all 10Show fewer
- Pregnant or lactating women
- Severe infectious disease (uncured tuberculosis, pulmonary aspergillosis)
- Epilepsia, dementia or any mental disease requiring treatment.
- Other conditions deemed inappropriate for study participation by the investigator.
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
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin
About this study
Official title: Recombinant Human Thrombopoietin for Autologous Hematopoietic Stem Cell Mobilization in Acute Leukemia: A Single-Arm Prospective Study
Evaluation of the efficacy and safety of recombinant human thrombopoietin (rhTPO) at 300 U/kg/day for hematopoietic stem cell mobilization in autologous transplantation among acute leukemia patients
- Conditions
- Hematopoietic Stem Cell Mobilization
- Being tested
- Recombinant Human Thrombopoietin（rhTPO）
- Keywords
- Recombinant Human Thrombopoietin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Human Thrombopoietin（rhTPO）Drug
G-CSF will be administered at a dose of 10 μg/kg/day subcutaneously for 7-10 days post-chemotherapy.
rhTPO is started on the same day as G-CSF at 300 U/kg/d and injected subcutaneously until the stem cell collection was completed.
| Study group | Role | What they receive |
|---|---|---|
| The group of rhTPO | Experimental | Not described Receives: Drug: Recombinant Human Thrombopoietin（rhTPO） |
What is being measured
The primary outcome is the main question the study is designed to answer.
total CD34+ cell count
Median total number of CD34+ cells collected
Measured: two weeks
Secondary outcomes (5)
the proportion of patients collecting more than or equal to 2*10^6 CD34+ cells/kg
Measured: two weeks
the proportion of patients collecting more than or equal to 5*10^6 CD34+ cells/kg
Measured: two weeks
total mononuclear cell count
Median total number of mononuclear cells collected
Measured: two weeks
time of platelet engraftment
defined as platelet count >20×109 platelets/L for seven consecutive days without platelet transfusion
Measured: eight weeks
time of neutrophil engraftment
defined as the absolute value of neutrophils >0.5×109 cells/L for three consecutive days
Measured: four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2025
- Study start30 May 2025 (estimated)
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic Stem Cell MobilizationStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06955858
- Sponsor's protocol ID
- IIT2025002
- Status last verified
- Apr 2025
- First submitted
- 26 Mar 2025
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recombinant Human Thrombopoietin for Autologous Hematopoietic Stem Cell Mobilization in Acute Leukemia: A Single-Arm Prospective Study
- ClinicalTrials.gov ID
- NCT06955858
- Acronym / sponsor ID
- IIT2025002
- Conditions
- Hematopoietic Stem Cell Mobilization
- Keywords
- Recombinant Human Thrombopoietin
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 30 May 2025 (estimated)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 2 May 2025 (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.
Evaluation of the efficacy and safety of recombinant human thrombopoietin (rhTPO) at 300 U/kg/day for hematopoietic stem cell mobilization in autologous transplantation among acute leukemia patients
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The group of rhTPO | Experimental | Drug: Recombinant Human Thrombopoietin（rhTPO） |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18～65 years, regardless of gender.
- Histopathologically confirmed acute leukemia with immunohistochemical validation
- Sustained complete hematologic remission with documented minimal residual disease (MRD) negativity.
- Eastern Cooperative Oncology Group (ECOG) performance status smaller than 2 and a life expectancy of more than 6 months
- No active infectious disease; no severe organ failure.
Key exclusion criteria (10 listed)
- Liver dysfunction (alanine aminotransferase or bilirubin greater than two times the normal upper limit).
- Renal dysfunction (creatinine or urea higher than 1.5 times the normal upper limit).
- Any disease that could put patients at high risk, including but not limited to unstable cardiac disease, uncontrolled atrial fibrillation or hypertension, severe diabetic retinopathy
- rhTPO aller- gies.
- Severe prior thrombosis-event.
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 Thrombopoietin（rhTPO）G-CSF will be administered at a dose of 10 μg/kg/day subcutaneously for 7-10 days post-chemotherapy. rhTPO is started on the same day as G-CSF at 300 U/kg/d and injected subcutaneously until the stem cell collection was completed. | Drug | The group of rhTPO |
Primary outcome
total CD34+ cell count
Time frame: two weeks
Median total number of CD34+ cells collected
5 secondary outcomes
the proportion of patients collecting more than or equal to 2*10^6 CD34+ cells/kg
Time frame: two weeks
the proportion of patients collecting more than or equal to 5*10^6 CD34+ cells/kg
Time frame: two weeks
total mononuclear cell count
Time frame: two weeks
time of platelet engraftment
Time frame: eight weeks
time of neutrophil engraftment
Time frame: four 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 2 May 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recombinant Human Thrombopoietin（rhTPO） in people with Hematopoietic Stem Cell Mobilization, 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 6 inclusion and 10 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: opening soon, as of the sponsor's last update on 2 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.
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?
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?
total CD34+ cell count (time frame: two weeks). 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 2 May 2025.