PEG-rhG-CSF Compared With rhG-CSF in Lymphoma Patients After Autologous Hematopoietic Stem Cell Transplantation

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the efficacy and safety of PEG-rhG-CSF compared with rhG-CSF on the recovery of hematopoietic function after autologous stem cell transplantation in patients with lymphoma.

Detailed Description
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The purpose of the study is to evaluate the efficacy and safety of PEG-rhG-CSF compared with rhG-CSF in lymphoma patients after autologous hematopoietic stem cell transplantation. Eligible patients were randomly assigned to PEG-rhG-CSF group or rhG-CSF group. Patients in PEG-rhG-CSF group received PEG-rhG-CSF day +1 after transplantation with a dose of 6 mg. Patients in rhG-CSF group received rhG-CSF day +1 after transplantation with a dose of 5μg/kg once per day until the count of neutrophil>0.5×10^9 /L.

Official Title
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A Multicenter Randomized Controlled Trial of the Efficacy and Safety of PEG-rhG-CSF Compared With rhG-CSF After Autologous Hematopoietic Stem Cell Transplantation for Lymphoma Patients

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: Patients with age between 18 and 65 years; hematopoietic stem cell transplantation for the first time; Lymphoma patients with the requirement for autologous; ECOG score ≤2; Estimated survival time > 3 months; All acute toxicity caused by previous chemotherapy or treatment has been restored; 7.1) The absolute value of neutrophils (>1.5×10^9/L); Hemoglobin (> 90 g/L); 2)Upper Limit Normal (ULN) or creatinine clearance rate (>40 mL/min) of serum creatinine (<1.5 times normal value upper limit) (estimated by Cockcroft-Gault formula); Serum total bilirubin < 1.5 times ULN; Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) = 2.5 times ULN; 7) Coagulation function: International Normalized Ratio (INR) = 1.5 times ULN; Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT) = 1.5 times ULN (unless the subject is receiving anticoagulant therapy and PT and APTT are using anticoagulant therapy at screening time). Within the expected range; Thyrotropin (TSH) or free thyroxine (FT4) or free triiodothyronine (FT3) were all within the normal range (+10%); 8.Not in pregnancy; 9.Written informed consent are acquired. Exclusion Criteria: Had received autologous hematopoietic stem cell transplantation or allogeneic transplantation; bone marrow involvement; Patients with active autoimmune diseases requiring systematic treatment were excluded according to the clinical judgment of the investigators; Patients with active infections requiring systematic treatment were excluded according to the clinical judgment of the investigators; Serious complications, such as severe infection, heart, lung, liver and kidney dysfunction； patients in fever of unknown origin before medication（>38℃）； central nervous system involvement; Patients that received pelvic radiotherapy; patients will received Chemotherapy or radiotherapy under the diaphragm after transplantation ； Participation or consideration of participation in another biomedical study during the follow-up period of the present trial; Pregnant or lactating women; Serious heart, lung, hemorrhagic disease; Past psychiatric history; incapacitated or restricted; patient's condition increase the risk of receiving the drug treatment or confusion about the toxic reaction； Severe intolerance to the growth factor under study, or hypersensitivity to one of their components; the patients did not comply with the study; Other situation that investigators consider as contra-indication for this study.

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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PEG-rhG-CSF<br>Patients in PEG-rhG-CSF group received PEG-rhG-CSF day+1 after transplantation. | Drug: PEG-rhG-CSF<br>* PEG-rhG-CSF was given day +1 after autologous stem cell transplantation with a dose of 6mg.<br>|
| Active Comparator: rhG-CSF<br>Patients in rhG-CSF group received rhG-CSF day+1 after transplantation. | Drug: rhG-CSF<br>* rhG-CSF was given day +1 after autologous stem cell transplantation with a dose of 5μg/kg once per day until the count of neutrophil>0.5×10^9 /L.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to neutrophil engraftment |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The duration of neutrophilic granulocytopenia |  | 30 days | 
| Incidence of febrile neutrophilic granulocytopenia |  | 30 days | 
| Time to platelet engraftment and number of platelet transfused to the patient |  | 30 days | 
| Adverse Event | Safety | 30 days |