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RecruitingNCT06026995Updated Sep 7, 2023

Clinical Study on PEG-rhG-CSF in Mobilizing Autologous Hematopoietic Stem Cells

A Phase 4 interventional study of PEG-rhG-CSF and RhG-CSF in Lymphoma, sponsored by Chongqing University Cancer Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-09-07.

Sponsored by Chongqing University Cancer Hospital · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jan 2024, 2 years 9 months ago, but the record still lists the study as recruiting.
  • Registered 1 year 5 months after the study started (first participant enrolled Mar 2022, registered Aug 2023).
  • Started Mar 2022; still recruiting 4 years 7 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
174
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

This study is a randomized controlled, open and multi-center clinical study. Patients who meet the selection criteria and do not meet the exclusion criteria are randomly given PEG-rhG-CSF with a fixed dose of 12mg when white blood cells reach the lowest point, or given rhG-CSF with a daily mobilization of 5-10μ g/kg until the collection is completed, so as to evaluate the effectiveness and safety of PEG-rhG-CSF in mobilizing autologous stem cells for lymphoma and multiple myeloma.

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 174 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Chongqing University Cancer Hospital is the lead sponsor of 40 studies on the registry; 27 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. 18-65 years old, regardless of sex;
  2. Patients with lymphoma and multiple myeloma who need autologous hematopoietic stem cell transplantation;
  3. KPS score ≥70;
  4. creatinine clearance rate ≥ 50mL/min, total bilirubin level \< 1.5mg/dL, ALT and AST \< 2 times the upper limit of normal value;
  5. Absolute neutrophil count (ANC)≥1.5×109/L, platelet count ≥80×109/L, Hb≥ 75g/L, WBC ≥ 3.0× 109/L;
  6. Patients can tolerate chemotherapy;
  7. No active infection before chemotherapy;
  8. The patient voluntarily participated in this trial and signed the informed consent form;
  9. The researcher thinks that the subjects can benefit.

Exclusion criteria

Exclusion Criteria:

  1. Those who have previously received allogeneic or autologous hematopoietic stem cell transplantation;
  2. Serious or uncontrolled virus infection: HIV, syphilis positive;
  3. Severe dysfunction of internal organs;
  4. severe mental or nervous system diseases;
  5. allergic to PEG-rhG-CSF, rhG-CSF and other preparations or proteins expressed in Escherichia coli;
  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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
174 participants (estimated)

Study arms

  • Experimental
    experimental group

    Drug: PEG-rhG-CSF

  • Active comparator
    control group

    Drug: RhG-CSF

Interventions

  • DrugPEG-rhG-CSF

    Subcutaneous injection with a fixed dose of 12 mg

  • DrugRhG-CSF

    Inject rhG-CSF 5-10 μg/kg subcutaneously every day

06

What researchers measure

Primary outcomes

  1. The proportion of patients with CD34+ cells ≥2×106/kg

    The proportion of patients with CD34+ cells ≥2×106/kg

    Time frame: 28 days

Secondary outcomes

  1. CD34+cell count

    CD34+cell count

    Time frame: 28 days

  2. Acquisition times

    The number of times a patient needs to collect a sufficient number of CD34+ cells

    Time frame: 28 days

  3. Mobilization time

    Time interval from mobilization to collection

    Time frame: 28 days

  4. Hematopoietic reconstruction time after transplantation

    Hematopoietic reconstruction time after transplantation

    Time frame: 3 months

  5. complication

    complication

    Time frame: 3 months

07

Study locations

1 of 1 sites recruiting
  • Chongqing University Cancer Hospital
    Chongqing, Chongqing 400030, China
    Recruiting
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 Sep 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06026995
Lead sponsor
Chongqing University Cancer Hospital
Collaborators
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Responsible party
Yao Liu (Director, Chongqing University Cancer Hospital) — Principal investigator
First posted
Sep 7, 2023
Start date
Mar 1, 2022
Primary completion
Jan 1, 2024 (estimated)
Completion
Jun 1, 2024 (estimated)
Last update
Sep 7, 2023

Study contacts

Yao Liu, doctor
Contact
64823926@qq.com
132 2868 4685

Oversight

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

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