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

Sponsor
Ou Bai, MD/PHD (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05834751
Collaborator
(none)
144
Enrollment
1
Location
2
Arms
26
Anticipated Duration (Months)
5.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
144 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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.
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
May 1, 2025
Anticipated Study Completion Date :
Jul 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: experimental group

PEG-rhG-CSF

Drug: PEG-rhG-CSF
48-72 hours after chemotherapy,9 mg of PEG-rhG-CSF was injected subcutaneously for mobilization
Other Names:
  • pegfilgrastim

    		•
    Active Comparator: control group

    rhG-CSF

    Drug: RhG-CSF
    After clinical evaluation, rhG-CSF was given 10μ g/kg/d for mobilization until the stem cell collection was completed.
    Other Names:
  • filgrastim

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Mobilization success rate [48 months]

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

    Secondary Outcome Measures

    1. White blood cell trough and peak [30 days]

      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

    2. Speed of recovery [30 days]

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

    3. Time of highest point of CD34+ cells [30 days]

      Time of highest point of CD34+ cells

    4. Single acquisition volume [30 days]

      Single acquisition volume

    5. Acquisition times [30 days]

      Acquisition times

    6. Administration times of rhG-CSF [30 days]

      Administration times of rhG-CSF

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    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:

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The First Bethune Hospital of Jilin University Changchun Jilin China 130021

    Sponsors and Collaborators

    • Ou Bai, MD/PHD

    Investigators

    • Principal Investigator: Ou Bai, doctor, The First Hospital of Jilin University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ou Bai, MD/PHD, Director, The First Hospital of Jilin University
    ClinicalTrials.gov Identifier:
    NCT05834751
    Other Study ID Numbers:
    • CSPC-JYL-PBSCT-03A
    First Posted:
    Apr 28, 2023
    Last Update Posted:
    Apr 28, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lymphoma

    Study Results

    No Results Posted as of Apr 28, 2023