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Not yet recruitingNCT05834751Updated Apr 28, 2023

the Efficacy and Safety of PEG-rhG-CSF in Mobilizing Autologous Hematopoietic Stem Cells in Lymphoma

An interventional study of PEG-rhG-CSF and RhG-CSF in Lymphoma, sponsored by Ou Bai, MD/PHD. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-04-28.

Sponsored by Ou Bai, MD/PHD · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by May 2025, 1 year 5 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
144
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
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Study 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 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;

02

Conditions studied

  • Lymphoma

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03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's planned enrollment of 144 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.

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Lead sponsor

Ou Bai, MD/PHD is the lead sponsor of 7 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age 18-65 years old, regardless of gender;
  2. lymphoma patients who need to be prepared for autologous hematopoietic stem cell transplantation;
  3. KPS score ≥70;
  4. Ccr≥ 50 mL/min, TBIL\< 25.65 umol/L, ALT and AST \< 2 times the upper limit of normal value;
  5. ANC ≥ 1.5×109/L,PLT ≥ 80×109/L,Hb ≥ 75g/L,WBC ≥ 3.0×109/L;
  6. Patients can tolerate chemotherapy;
  7. No active infection before chemotherapy;
  8. 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;
  9. The researcher thinks that the subjects can benefit.

Exclusion criteria

Exclusion Criteria:

  1. Patients with megaspleen (when inhaling deeply, the spleen exceeds the right umbilicus and/or below the umbilical level);
  2. Those who have received mobilization and transplantation of allogeneic or autologous hematopoietic stem cells before;
  3. 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;
  4. severe mental or nervous system diseases;
  5. 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;
  6. pregnant or lactating female patients; Women of childbearing age refuse to accept contraceptive measures; Those who plan to become pregnant during the study period;
  7. The researcher judges other subjects who are not suitable to participate.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
144 participants (estimated)

Study arms

  • Experimental
    experimental group

    PEG-rhG-CSF

    Drug: PEG-rhG-CSF

  • Active comparator
    control group

    rhG-CSF

    Drug: RhG-CSF

Interventions

  • DrugPEG-rhG-CSF

    48-72 hours after chemotherapy,9 mg of PEG-rhG-CSF was injected subcutaneously for mobilization

    Also known as: pegfilgrastim

  • DrugRhG-CSF

    After clinical evaluation, rhG-CSF was given 10μ g/kg/d for mobilization until the stem cell collection was completed.

    Also known as: filgrastim

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What researchers measure

Primary outcomes

  1. Mobilization success rate

    Accumulate CD34+cells ≥ 2×106/kg for 3 times or less

    Time frame: 48 months

Secondary outcomes

  1. 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

    Time frame: 30 days

  2. Speed of recovery

    The number of days when the leucocyte trough rose to the peak

    Time frame: 30 days

  3. Time of highest point of CD34+ cells

    Time of highest point of CD34+ cells

    Time frame: 30 days

  4. Single acquisition volume

    Single acquisition volume

    Time frame: 30 days

  5. Acquisition times

    Acquisition times

    Time frame: 30 days

  6. Administration times of rhG-CSF

    Administration times of rhG-CSF

    Time frame: 30 days

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Study locations

1 site
  • The First Bethune Hospital of Jilin University
    Changchun, Jilin 130021, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 28, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05834751
Lead sponsor
Ou Bai, MD/PHD
Responsible party
Ou Bai, MD/PHD (Director, The First Hospital of Jilin University) — Sponsor-investigator
First posted
Apr 28, 2023
Start date
May 1, 2023 (estimated)
Primary completion
May 1, 2025 (estimated)
Completion
Jul 1, 2025 (estimated)
Last update
Apr 28, 2023

Study contacts

Ou Bai, doctor
Contact
oubai16@163.com
13039046656
Ou Bai, doctor
principal investigator · The First Hospital of Jilin University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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