the Efficacy and Safety of PEG-rhG-CSF in Mobilizing Autologous Hematopoietic Stem Cells in Lymphoma
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.
1 other identifier
interventional
144
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable lymphoma
Started May 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 6, 2023
CompletedFirst Posted
Study publicly available on registry
April 28, 2023
CompletedStudy Start
First participant enrolled
May 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2025
CompletedApril 28, 2023
April 1, 2023
2 years
April 6, 2023
April 18, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Mobilization success rate
Accumulate CD34+cells ≥ 2×106/kg for 3 times or less
48 months
Secondary Outcomes (6)
White blood cell trough and peak
30 days
Speed of recovery
30 days
Time of highest point of CD34+ cells
30 days
Single acquisition volume
30 days
Acquisition times
30 days
- +1 more secondary outcomes
Study Arms (2)
experimental group
EXPERIMENTALPEG-rhG-CSF
control group
ACTIVE COMPARATORrhG-CSF
Interventions
48-72 hours after chemotherapy,9 mg of PEG-rhG-CSF was injected subcutaneously for mobilization
After clinical evaluation, rhG-CSF was given 10μ g/kg/d for mobilization until the stem cell collection was completed.
Eligibility Criteria
You may qualify if:
- 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；
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ou Bai, MD/PHDlead
Study Sites (1)
The First Bethune Hospital of Jilin University
Changchun, Jilin, 130021, China
Related Publications (1)
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.
PMID: 41510127DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ou Bai, doctor
The First Hospital of Jilin University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
April 6, 2023
First Posted
April 28, 2023
Study Start
May 1, 2023
Primary Completion
May 1, 2025
Study Completion
July 1, 2025
Last Updated
April 28, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share