Mobilization of Hematopoietic Stem Cells (HSC) to Peripheral Blood (PB)Phase 2NCT07362810
G-CSF Combined With IL-11 on Hematopoietic Reconstitution After Autologous Hematopoietic Stem Cell Transplantation
A Phase 2 study testing G-CSF+IL-11 and G-CSF Granulocyte-Colony Stimulating Factor in people with Mobilization of Hematopoietic Stem Cells (HSC) to Peripheral Blood (PB) and Hematopoetic Stem Cell Transplantation, run by Fudan University at 7 sites in China.
Trial summary
Autologous hematopoietic stem cell transplantation(auto-HSCT) plays an important role in treating hematologic malignancies. Mobilization and collection of peripheral blood stem/progenitor cells is the key to successful autologous hematopoietic stem cell transplantation. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Mobilization of Hematopoietic Stem Cells (HSC) to Peripheral Blood (PB), Hematopoetic Stem Cell Transplantation, Hemato-oncologic Patients
- What is being tested?
- G-CSF+IL-11 and G-CSF Granulocyte-Colony Stimulating Factor
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 7 sitesChina
- Study dates
- 22 Jan 2026to 30 Dec 2026
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (≥18 years) with newly diagnosed multiple myeloma or lymphoma
- Suitable candidates for autologous hematopoietic stem cell transplantation (auto-HSCT)
- Zubrod (ECOG) performance status < 4
- Left ventricular ejection fraction (LVEF) > 40%
- No uncontrolled arrhythmia or unstable cardiac disease
- Corrected QT interval (QTc) < 470 ms
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- No symptomatic pulmonary disease, with acceptable pulmonary function tests
- Serum alanine aminotransferase (ALT) < 4 × upper limit of normal (ULN)
- Total bilirubin < 2 × upper limit of normal (ULN)
Who cannot join
- Intolerance to auto-HSCT
- Prior exposure to other stem cell mobilizing agents
- Pregnancy or lactation
- Psychiatric disorders precluding participation
- Positive serology for HIV (HIV-1/2), hepatitis B, or hepatitis C
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
China7 sites, 7 recruiting
- Recruiting
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350004
Apeng Yang, +86 15059484251, apengyang@163.com
- Recruiting
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310006
+8615858199217, yanminzhao@zju.edu.cn
- Recruiting
Jiangxi Cancer Hospital
Nanchang, Jiangxi, 330029
Wuping Li, +8617717859336, 18907001021@163.com
- Recruiting
Huadong Hospital, Fudan University
Shanghai, Shanghai Municipality, 200040
Jiexian Ma, +8613764520566, jiexianma@hotmail.com
- Recruiting
Tongji Hospital of Tongji University
Shanghai, Shanghai Municipality, 200065
Wenjun Zhang, +86 13918803148, zhangwenjun@tongji.edu.cn
- Recruiting
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200092
Jiangbo Wan, +86-13661638146, wanjiangbo@xinhuamed.com.cn
- Recruiting
The first affiliated hospital of Zhengzhou university
Zhengzhou, Henan, 450052
Zhilei Bian, +86 13918803148, bianzhilei@sina.com
About this study
Official title: The Impact of G-CSF Combined With IL-11 on Hematopoietic Reconstitution After Autologous Hematopoietic Stem Cell Transplantation
Autologous hematopoietic stem cell transplantation(auto-HSCT) plays an important role in treating hematologic malignancies. Mobilization and collection of peripheral blood stem/progenitor cells is the key to successful autologous hematopoietic stem cell transplantation. Currently mobilization regimens are not enough in increasing the yield of megakaryocytic or erythroid stem/progenitor cells, resulting in a delay of hematopoietic reconstitution of platelets and erythrocytes. IL-11 and G-CSF have a synergistic role in mobilizing peripheral blood stem cells towards megakaryocytic or erythroid stem/progenitor cells in a preclinical study. Furthermore, a single-center, small cohort, prospective clinical study that has been completed in China(ChiCTR2500100054), which showed that after five days of mobilization, the combination of G-CSF and IL-11 significantly increased the number and proportion of functional megakaryocytic/erythroid progenitor cells in the peripheral blood mononuclear cells of patients, and also significantly shortened the time for platelet engraftment after transplantation, and also reduced the demand for red blood cell and platelet transfusions compared to G-CSF alone. A multi-center, prospective random clinical study is essential to compare the efficacy and safety of novel mobilization regimen with IL-11 plus G-CSF to G-CSF alone.
- Conditions
- Mobilization of Hematopoietic Stem Cells (HSC) to Peripheral Blood (PB), Hematopoetic Stem Cell Transplantation, Hemato-oncologic Patients
- Being tested
- G-CSF+IL-11, G-CSF Granulocyte-Colony Stimulating Factor
- Keywords
- IL-11, mobilization, hematopoetic stem cell transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G-CSF+IL-11Drug
rhG-CSF 5 μg/kg/day for 6 days plus rhIL-11 50 μg/kg/day for 5 days
G-CSF Granulocyte-Colony Stimulating FactorDrug
rhG-CSF 5 μg/kg/day subcutaneously for 6 days
| Study group | Role | What they receive |
|---|---|---|
| G-CSF+IL-11 | Experimental | rhG-CSF 5 μg/kg/day for 6 days plus rhIL-11 50 μg/kg/day for 5 days Receives: Drug: G-CSF+IL-11 |
| G-CSF | Active comparator | rhG-CSF 5 μg/kg/day subcutaneously for 6 days. Receives: Drug: G-CSF Granulocyte-Colony Stimulating Factor |
What is being measured
The primary outcome is the main question the study is designed to answer.
hematopoietic engraftment time (including granulocyte engraftment and platelet engraftment)
Granulocyte Engraftment Time: Defined as the number of days from stem cell infusion (Day 0) to the first of three consecutive days with an Absolute Neutrophil Count (ANC) > 0.5 × 10^9/L.
Platelet Recovery Time: Defined as the number of days from stem cell infusion (Day 0) to the first day of seven consecutive days with a platelet count (PLT) ≥ 20 × 10^9/L without transfusion support.
Measured: Data on engraftment will be collected daily from stem cell infusion (Day 0) until the occurrence of both engraftment events or up to a maximum of 100 days, whichever comes first.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
AEs were evaluated according to the National Cancer Institute Common Terminology Criteria of Adverse Events, version 4.0.
Measured: Adverse events are monitored from the time of enrollment (first study intervention) through the end of the study, with an expected average follow-up of 12 months.
Secondary outcomes (1)
progression-free survival (PFS) and overall survival (OS)
Measured: PFS: From randomization to disease progression or death from any cause, whichever occurs first, through study completion, an average of 1 year. OS: From randomization to death from any cause, through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start22 Jan 2026
- Primary completion30 Dec 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 Mobilization of Hematopoietic Stem Cells (HSC) to Peripheral Blood (PB)Studies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- random assigned, two groups, one group was the novel regimen of G-CSF plus IL-11, another one is the traditional regimen G-CSF alone.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Tongji Hospital, Tongji University School of Medicine, The First Affiliated Hospital of Zhengzhou University, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, First Affiliated Hospital of Fujian Medical University, First Affiliated Hospital of Zhejiang University, Jiangxi Provincial Cancer Hospital
- Responsible party
- Principal investigator, Zhijun Bao, Fudan University
- Investigators
- Jiexian Ma, Principal investigator, Huadong Hospitai, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07362810
- Sponsor's protocol ID
- 2025K388-F251
- Status last verified
- Jan 2026
- First submitted
- 2 Jan 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of G-CSF Combined With IL-11 on Hematopoietic Reconstitution After Autologous Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT07362810
- Acronym / sponsor ID
- 2025K388-F251
- Conditions
- Mobilization of Hematopoietic Stem Cells (HSC) to Peripheral Blood (PB), Hematopoetic Stem Cell Transplantation, Hemato-oncologic Patients
- Keywords
- IL-11, mobilization, hematopoetic stem cell transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- Shanghai Tongji Hospital, Tongji University School of Medicine, The First Affiliated Hospital of Zhengzhou University, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, First Affiliated Hospital of Fujian Medical University, First Affiliated Hospital of Zhejiang University, Jiangxi Provincial Cancer Hospital
- Study start
- 22 Jan 2026 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 23 Jan 2026 (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.
Autologous hematopoietic stem cell transplantation(auto-HSCT) plays an important role in treating hematologic malignancies. Mobilization and collection of peripheral blood stem/progenitor cells is the key to successful autologous hematopoietic stem cell transplantation. Currently mobilization regimens are not enough in increasing the yield of megakaryocytic or erythroid stem/progenitor cells, resulting in a delay of hematopoietic reconstitution of platelets and erythrocytes. IL-11 and G-CSF have a synergistic role in mobilizing peripheral blood stem cells towards megakaryocytic or erythroid stem/progenitor cells in a preclinical study. Furthermore, a single-center, small cohort, prospective clinical study that has been completed in China(ChiCTR2500100054), which showed that after five days of mobilization, the combination of G-CSF and IL-11 significantly increased the number and proportion of functional megakaryocytic/erythroid progenitor cells in the peripheral blood mononuclear cells of patients, and also significantly shortened the time for platelet engraftment after transplantation, and also reduced the demand for red blood cell and platelet transfusions compared to G-CSF alone. A multi-center, prospective random clinical study is essential to compare the efficacy and safety of novel mobilization regimen with IL-11 plus G-CSF to G-CSF alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- random assigned, two groups, one group was the novel regimen of G-CSF plus IL-11, another one is the traditional regimen G-CSF alone.
| Arm | Type | Receives |
|---|---|---|
| G-CSF+IL-11 | Experimental | Drug: G-CSF+IL-11rhG-CSF 5 μg/kg/day for 6 days plus rhIL-11 50 μg/kg/day for 5 days |
| G-CSF | Active comparator | Drug: G-CSF Granulocyte-Colony Stimulating FactorrhG-CSF 5 μg/kg/day subcutaneously for 6 days. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adults (≥18 years) with newly diagnosed multiple myeloma or lymphoma
- Suitable candidates for autologous hematopoietic stem cell transplantation (auto-HSCT)
- Zubrod (ECOG) performance status < 4
- Left ventricular ejection fraction (LVEF) > 40%
- No uncontrolled arrhythmia or unstable cardiac disease
Key exclusion criteria (5 listed)
- Intolerance to auto-HSCT
- Prior exposure to other stem cell mobilizing agents
- Pregnancy or lactation
- Psychiatric disorders precluding participation
- Positive serology for HIV (HIV-1/2), hepatitis B, or hepatitis C
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 |
|---|---|---|
| G-CSF+IL-11rhG-CSF 5 μg/kg/day for 6 days plus rhIL-11 50 μg/kg/day for 5 days | Drug | G-CSF+IL-11 |
| G-CSF Granulocyte-Colony Stimulating FactorrhG-CSF 5 μg/kg/day subcutaneously for 6 days | Drug | G-CSF |
Primary outcome
hematopoietic engraftment time (including granulocyte engraftment and platelet engraftment)
Time frame: Data on engraftment will be collected daily from stem cell infusion (Day 0) until the occurrence of both engraftment events or up to a maximum of 100 days, whichever comes first.
Granulocyte Engraftment Time: Defined as the number of days from stem cell infusion (Day 0) to the first of three consecutive days with an Absolute Neutrophil Count (ANC) > 0.5 × 10^9/L. Platelet Recovery Time: Defined as the number of days from stem cell infusion (Day 0) to the first day of seven consecutive days with a platelet count (PLT) ≥ 20 × 10^9/L without transfusion support.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: Adverse events are monitored from the time of enrollment (first study intervention) through the end of the study, with an expected average follow-up of 12 months.
AEs were evaluated according to the National Cancer Institute Common Terminology Criteria of Adverse Events, version 4.0.
1 secondary outcome
progression-free survival (PFS) and overall survival (OS)
Time frame: PFS: From randomization to disease progression or death from any cause, whichever occurs first, through study completion, an average of 1 year. OS: From randomization to death from any cause, through study completion, an average of 1 year.
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 22 Oct 2026.
- Individual participant dataSharing planned: Yes. All collected IPD
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.
Jiexian Ma principal investigator
Huadong Hospitai, Fudan University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing G-CSF+IL-11 and G-CSF Granulocyte-Colony Stimulating Factor in people with Mobilization of Hematopoietic Stem Cells (HSC) to Peripheral Blood (PB) and Hematopoetic Stem Cell Transplantation, run by Fudan University at 7 sites 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 5 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 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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 Jiexian Ma (+86 13764520566, jiexianma@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hematopoietic engraftment time (including granulocyte engraftment and platelet engraftment) (time frame: Data on engraftment will be collected daily from stem cell infusion (Day 0) until the occurrence of both engraftment events or up to a maximum of 100 days, whichever comes first.). 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?
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 22 Oct 2026.