LymphomaNCT05834751
the Efficacy and Safety of PEG-rhG-CSF in Mobilizing Autologous Hematopoietic Stem Cells in Lymphoma
A study testing PEG-rhG-CSF and RhG-CSF in people with Lymphoma, run by Ou Bai, MD/PHD at 1 site in China.
Trial summary
A single center, non-inferiority, two-way cohort clinical study to evaluate the efficacy and safety of pegylated recombinant human granulocyte stimulating factor injection in the mobilization of autologous hematopoietic stem cells in lymphoma. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lymphoma
- What is being tested?
- PEG-rhG-CSF and RhG-CSF
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2023to 1 Jul 2025
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years old, regardless of gender;
- lymphoma patients who need to be prepared for autologous hematopoietic stem cell transplantation;
- KPS score ≥70;
- Ccr≥ 50 mL/min, TBIL< 25.65 umol/L, ALT and AST < 2 times the upper limit of normal value;
- ANC ≥ 1.5×109/L，PLT ≥ 80×109/L，Hb ≥ 75g/L，WBC ≥ 3.0×109/L；
- Patients can tolerate chemotherapy；
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- No active infection before chemotherapy;
- The retrospective enrolled subjects are exempted from informed consent for data collection, and the prospective enrolled subjects voluntarily participate in this experiment and sign the informed consent form;
- The researcher thinks that the subjects can benefit.
Who cannot join
- Patients with megaspleen (when inhaling deeply, the spleen exceeds the right umbilicus and/or below the umbilical level);
- Those who have received mobilization and transplantation of allogeneic or autologous hematopoietic stem cells before;
- Subjects who have evidence of serious or uncontrollable systemic diseases (such as unstable or irreparable respiratory, heart, liver or kidney diseases) according to the researcher's judgment;
- severe mental or nervous system diseases;
- Those who are allergic to PEG-rhG-CSF, rhG-CSF and any active ingredients or auxiliary materials of other preparations expressed by Escherichia coli, or have a clear history of protein drug allergy, specific allergic reaction (asthma, rheumatism, eczema dermatitis) or have had other serious allergic reactions;
- pregnant or lactating female patients; Women of childbearing age refuse to accept contraceptive measures; Those who plan to become pregnant during the study period;
- The researcher judges other subjects who are not suitable to participate.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Bethune Hospital of Jilin University
Changchun, Jilin, 130021
Ou Bai, doctor, 13039046656, oubai@163.com
About this study
Official title: Clinical Study on the Effectiveness and Safety of Pegylated Recombinant Human Granulocyte Stimulating Factor Injection and PEG-rhG-CSF in Mobilizing Autologous Hematopoietic Stem Cells in Lymphoma.
A single center, non-inferiority, two-way cohort clinical study to evaluate the efficacy and safety of pegylated recombinant human granulocyte stimulating factor injection in the mobilization of autologous hematopoietic stem cells in lymphoma.
Read the detailed description
The objective was to to evaluate the efficacy and safety of pegylated recombinant human granulocyte stimulating factor injection in the mobilization of autologous hematopoietic stem cells in lymphoma.
lymphoma patients who need to be prepared for autologous hematopoietic stem cell transplantation; KPS score ≥70; Ccr≥ 50 mL/min, TBIL< 25.65 umol/L, ALT and AST < 2 times the upper limit of normal value;
- Conditions
- Lymphoma
- Being tested
- PEG-rhG-CSF, RhG-CSF
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG-rhG-CSFDrug
Also called pegfilgrastim
48-72 hours after chemotherapy,9 mg of PEG-rhG-CSF was injected subcutaneously for mobilization
RhG-CSFDrug
Also called filgrastim
After clinical evaluation, rhG-CSF was given 10μ g/kg/d for mobilization until the stem cell collection was completed.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | PEG-rhG-CSF Receives: Drug: PEG-rhG-CSF |
| control group | Active comparator | rhG-CSF Receives: Drug: RhG-CSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mobilization success rate
Accumulate CD34+cells ≥ 2×106/kg for 3 times or less
Measured: 48 months
Secondary outcomes (6)
White blood cell trough and peak
The treatment period is from the beginning of chemotherapy to the end of collection, the trough value is recorded at the beginning of chemotherapy, and the peak value is recorded after PEG-rhG-CSF is applied
Measured: 30 days
Speed of recovery
The number of days when the leucocyte trough rose to the peak
Measured: 30 days
Time of highest point of CD34+ cells
Time of highest point of CD34+ cells
Measured: 30 days
Single acquisition volume
Single acquisition volume
Measured: 30 days
Acquisition times
Acquisition times
Measured: 30 days
Administration times of rhG-CSF
Administration times of rhG-CSF
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start1 May 2023 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion1 Jul 2025 (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 LymphomaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ou Bai, MD/PHD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ou Bai, MD/PHD, The First Hospital of Jilin University
- Investigators
- Ou Bai, doctor, Principal investigator, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05834751
- Sponsor's protocol ID
- CSPC-JYL-PBSCT-03A
- Status last verified
- Apr 2023
- First submitted
- 6 Apr 2023
- Last updated
- 28 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang B, Cao L, Li J, Zhao Y, Li J, Wen Y, Yan P, Guo W, Bai O. Polyethylene glycol-conjugated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF) primary prophylaxis significantly reduces the duration of neutropenia in non-Hodgkin's lymphoma patients treated with chemotherapy: a randomised trial (NCT05834751). Transl Cancer Res. 2025 Dec 31;14(12):8990-9001. doi: 10.21037/tcr-2025-1-2613. Epub 2025 Dec 29.
PubMed 41510127
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Effectiveness and Safety of Pegylated Recombinant Human Granulocyte Stimulating Factor Injection and PEG-rhG-CSF in Mobilizing Autologous Hematopoietic Stem Cells in Lymphoma.
- ClinicalTrials.gov ID
- NCT05834751
- Acronym / sponsor ID
- CSPC-JYL-PBSCT-03A
- Conditions
- Lymphoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Ou Bai, MD/PHDUniversity, hospital or other
- Study start
- 1 May 2023 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 28 Apr 2023 (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.
A single center, non-inferiority, two-way cohort clinical study to evaluate the efficacy and safety of pegylated recombinant human granulocyte stimulating factor injection in the mobilization of autologous hematopoietic stem cells in lymphoma.
Detailed description
The objective was to to evaluate the efficacy and safety of pegylated recombinant human granulocyte stimulating factor injection in the mobilization of autologous hematopoietic stem cells in lymphoma.
lymphoma patients who need to be prepared for autologous hematopoietic stem cell transplantation; KPS score ≥70; Ccr≥ 50 mL/min, TBIL< 25.65 umol/L, ALT and AST < 2 times the upper limit of normal value;
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Drug: PEG-rhG-CSFPEG-rhG-CSF |
| control group | Active comparator | Drug: RhG-CSFrhG-CSF |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18-65 years old, regardless of gender;
- lymphoma patients who need to be prepared for autologous hematopoietic stem cell transplantation;
- KPS score ≥70;
- Ccr≥ 50 mL/min, TBIL< 25.65 umol/L, ALT and AST < 2 times the upper limit of normal value;
- ANC ≥ 1.5×109/L，PLT ≥ 80×109/L，Hb ≥ 75g/L，WBC ≥ 3.0×109/L；
Key exclusion criteria (7 listed)
- Patients with megaspleen (when inhaling deeply, the spleen exceeds the right umbilicus and/or below the umbilical level);
- Those who have received mobilization and transplantation of allogeneic or autologous hematopoietic stem cells before;
- Subjects who have evidence of serious or uncontrollable systemic diseases (such as unstable or irreparable respiratory, heart, liver or kidney diseases) according to the researcher's judgment;
- severe mental or nervous system diseases;
- Those who are allergic to PEG-rhG-CSF, rhG-CSF and any active ingredients or auxiliary materials of other preparations expressed by Escherichia coli, or have a clear history of protein drug allergy, specific allergic reaction (asthma, rheumatism, eczema dermatitis) or have had other serious allergic reactions;
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 |
|---|---|---|
| PEG-rhG-CSFAlso: pegfilgrastim48-72 hours after chemotherapy,9 mg of PEG-rhG-CSF was injected subcutaneously for mobilization | Drug | experimental group |
| RhG-CSFAlso: filgrastimAfter clinical evaluation, rhG-CSF was given 10μ g/kg/d for mobilization until the stem cell collection was completed. | Drug | control group |
Primary outcome
Mobilization success rate
Time frame: 48 months
Accumulate CD34+cells ≥ 2×106/kg for 3 times or less
6 secondary outcomes
White blood cell trough and peak
Time frame: 30 days
Speed of recovery
Time frame: 30 days
Time of highest point of CD34+ cells
Time frame: 30 days
Single acquisition volume
Time frame: 30 days
Acquisition times
Time frame: 30 days
Administration times of rhG-CSF
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2023.
- Derived from this study: PubMed 41510127Wang B, Cao L, Li J, Zhao Y, Li J, Wen Y, Yan P, Guo W, Bai O. Polyethylene glycol-conjugated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF) primary prophylaxis significantly reduces the duration of neutropenia in non-Hodgkin's lymphoma patients treated with chemotherapy: a randomised trial (NCT05834751). Transl Cancer Res. 2025 Dec 31;14(12):8990-9001. doi: 10.21037/tcr-2025-1-2613. Epub 2025 Dec 29.
- 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.
Ou Bai, doctor principal investigator
The First Hospital of Jilin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEG-rhG-CSF and RhG-CSF in people with Lymphoma, run by Ou Bai, MD/PHD 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: status not confirmed, as of the sponsor's last update on 28 Apr 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ou Bai, doctor (13039046656, oubai16@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mobilization success rate (time frame: 48 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 NCT05834751, 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 28 Apr 2023.