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

Study Overview
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Brief Summary
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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
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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;

Official Title
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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.

Conditions
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Lymphoma

Intervention / Treatment
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* Drug: PEG-rhG-CSF
* Drug: RhG-CSF


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental group<br>PEG-rhG-CSF | Drug: PEG-rhG-CSF<br>* 48-72 hours after chemotherapy,9 mg of PEG-rhG-CSF was injected subcutaneously for mobilization<br>* Other names: pegfilgrastim;|
| Active Comparator: control group<br>rhG-CSF | Drug: RhG-CSF<br>* After clinical evaluation, rhG-CSF was given 10μ g/kg/d for mobilization until the stem cell collection was completed.<br>* Other names: filgrastim;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mobilization success rate | Accumulate CD34+cells ≥ 2×106/kg for 3 times or less | 48 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 30 days | 
| Speed of recovery | The number of days when the leucocyte trough rose to the peak | 30 days | 
| Time of highest point of CD34+ cells | Time of highest point of CD34+ cells | 30 days | 
| Single acquisition volume | Single acquisition volume | 30 days | 
| Acquisition times | Acquisition times | 30 days | 
| Administration times of rhG-CSF | Administration times of rhG-CSF | 30 days |