PEG-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 on the recovery of hematopoietic function after autologous stem cell transplantation in patients with lymphoma.

Detailed Description
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At present, there is few related research of Recombinant Human Granulocyte Colony-stimulating Factor applying to AHSCT in China. The purpose of the study is to evaluate the efficacy and safety of PEG-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 100μg/kg. Patients with the weight more than 45kg were suggested a dose of 6 mg. Patients in control group received rhG-CSF day +1 after transplantation with a dose of 5μg/kg once per day until the recovery of neutrophil.

Official Title
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A Single Center Randomized Controlled Trial of the Efficacy and Safety of PEG-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. Lymphoma patients with the requirement for autologous hematopoietic stem cell transplantation. The collected CD34+ cells≥1×10E6/kg. ECOG score ≤2. Heart and lung is normal. Blood creatinine ≤1.5×ULN. ALT, AST, TBIL ≤2 ×ULN Not in pregnancy. Written informed consent are acquired. Exclusion Criteria: Had received autologous hematopoietic stem cell transplantation or allogeneic transplantation. Severe or uncontrolled infectious diseases: HIV, HCV, syphilis, ALT, chronic hepatitis B. Serious complications, such as severe infection, heart, lung, liver and kidney dysfunction. LVEF <55%. Allergic to the product or other biological products from genetically engineered Escherichia coli strains. Refused to take contraceptive measures during the study period and the subsequent 1 years. Severe mental or neurological disorders. Serious heart, lung, central nervous system disorders. Sickle cell anemia, hemolytic anemia and other hematologic diseases. Participate in other drugs clinical trials 30 days before the screening. 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 100μg/kg(bw).For patients more than 45kg, 6mg was suggested.<br>|
| Active Comparator: rhG-CSF<br>Patients in control group received rhG-CSF day +1 after transplantation. | Drug: rhG-CSF<br>* rhG-CSF was given day +1 after transplantation with a dose of 5μg/kg once per day<br>|

What is the study measuring?
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Primary Outcome Measures

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