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

Study Overview
=================
Brief 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.

Official Title
-----------------
Clinical Study on the Effectiveness and Safety of PEG-rhG-CSF in Mobilizing Autologous Hematopoietic Stem Cells for Lymphoma and Multiple Myeloma

Conditions
-----------------
Lymphoma

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-65 years old, regardless of sex; Patients with lymphoma and multiple myeloma who need autologous hematopoietic stem cell transplantation; KPS score ≥70; creatinine clearance rate ≥ 50mL/min, total bilirubin level < 1.5mg/dL, ALT and AST < 2 times the upper limit of normal value; Absolute neutrophil count (ANC)≥1.5×109/L, platelet count ≥80×109/L, Hb≥ 75g/L, WBC ≥ 3.0× 109/L; Patients can tolerate chemotherapy; No active infection before chemotherapy; The patient voluntarily participated in this trial and signed the informed consent form; The researcher thinks that the subjects can benefit. Exclusion Criteria: Those who have previously received allogeneic or autologous hematopoietic stem cell transplantation; Serious or uncontrolled virus infection: HIV, syphilis positive; Severe dysfunction of internal organs; severe mental or nervous system diseases; allergic to PEG-rhG-CSF, rhG-CSF and other preparations or proteins expressed in Escherichia coli; 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
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental group<br> | Drug: PEG-rhG-CSF<br>* Subcutaneous injection with a fixed dose of 12 mg<br>|
| Active Comparator: control group<br> | Drug: RhG-CSF<br>* Inject rhG-CSF 5-10 μg/kg subcutaneously every day<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients with CD34+ cells ≥2×106/kg | The proportion of patients with CD34+ cells ≥2×106/kg | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CD34+cell count | CD34+cell count | 28 days | 
| Acquisition times | The number of times a patient needs to collect a sufficient number of CD34+ cells | 28 days | 
| Mobilization time | Time interval from mobilization to collection | 28 days | 
| Hematopoietic reconstruction time after transplantation | Hematopoietic reconstruction time after transplantation | 3 months | 
| complication | complication | 3 months |