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

Primary Purpose

Lymphoma

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
PEG-rhG-CSF
RhG-CSF
Sponsored by
Ou Bai, MD/PHD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • The First Bethune Hospital of Jilin University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

experimental group

control group

Arm Description

PEG-rhG-CSF

rhG-CSF

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Speed of recovery
The number of days when the leucocyte trough rose to the peak
Time of highest point of CD34+ cells
Time of highest point of CD34+ cells
Single acquisition volume
Single acquisition volume
Acquisition times
Acquisition times
Administration times of rhG-CSF
Administration times of rhG-CSF

Full Information

First Posted
April 6, 2023
Last Updated
April 18, 2023
Sponsor
Ou Bai, MD/PHD
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1. Study Identification

Unique Protocol Identification Number
NCT05834751
Brief Title
the Efficacy and Safety of PEG-rhG-CSF in Mobilizing Autologous Hematopoietic Stem Cells in Lymphoma
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.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 1, 2023 (Anticipated)
Primary Completion Date
May 1, 2025 (Anticipated)
Study Completion Date
July 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ou Bai, MD/PHD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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;

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
144 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
experimental group
Arm Type
Experimental
Arm Description
PEG-rhG-CSF
Arm Title
control group
Arm Type
Active Comparator
Arm Description
rhG-CSF
Intervention Type
Drug
Intervention Name(s)
PEG-rhG-CSF
Other Intervention Name(s)
pegfilgrastim
Intervention Description
48-72 hours after chemotherapy,9 mg of PEG-rhG-CSF was injected subcutaneously for mobilization
Intervention Type
Drug
Intervention Name(s)
RhG-CSF
Other Intervention Name(s)
filgrastim
Intervention Description
After clinical evaluation, rhG-CSF was given 10μ g/kg/d for mobilization until the stem cell collection was completed.
Primary Outcome Measure Information:
Title
Mobilization success rate
Description
Accumulate CD34+cells ≥ 2×106/kg for 3 times or less
Time Frame
48 months
Secondary Outcome Measure Information:
Title
White blood cell trough and peak
Description
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
Title
Speed of recovery
Description
The number of days when the leucocyte trough rose to the peak
Time Frame
30 days
Title
Time of highest point of CD34+ cells
Description
Time of highest point of CD34+ cells
Time Frame
30 days
Title
Single acquisition volume
Description
Single acquisition volume
Time Frame
30 days
Title
Acquisition times
Description
Acquisition times
Time Frame
30 days
Title
Administration times of rhG-CSF
Description
Administration times of rhG-CSF
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ou Bai, doctor
Phone
13039046656
Email
oubai16@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ou Bai, doctor
Organizational Affiliation
The First Hospital of Jilin University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Bethune Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ou Bai, doctor
Phone
13039046656
Email
oubai@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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