PEG-rhG-CSF Compared With rhG-CSF in Lymphoma Patients After Autologous Hematopoietic Stem Cell Transplantation
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: PEG-rhG-CSF Patients in PEG-rhG-CSF group received PEG-rhG-CSF day+1 after transplantation. |
Drug: PEG-rhG-CSF
PEG-rhG-CSF was given day +1 after autologous stem cell transplantation with a dose of 6mg.
|
| Active Comparator: rhG-CSF Patients in rhG-CSF group received rhG-CSF day+1 after transplantation. |
Drug: rhG-CSF
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.
|
Outcome Measures
Primary Outcome Measures
- Time to neutrophil engraftment [30 days]
Secondary Outcome Measures
- 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 [30 days]
Safety
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients with age between 18 and 65 years;
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hematopoietic stem cell transplantation for the first time;
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Lymphoma patients with the requirement for autologous;
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ECOG score ≤2;
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Estimated survival time > 3 months;
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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:
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Had received autologous hematopoietic stem cell transplantation or allogeneic transplantation;
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bone marrow involvement;
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Patients with active autoimmune diseases requiring systematic treatment were excluded according to the clinical judgment of the investigators;
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Patients with active infections requiring systematic treatment were excluded according to the clinical judgment of the investigators;
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Serious complications, such as severe infection, heart, lung, liver and kidney dysfunction；
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patients in fever of unknown origin before medication（>38℃）；
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central nervous system involvement;
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Patients that received pelvic radiotherapy;
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patients will received Chemotherapy or radiotherapy under the diaphragm after transplantation ；
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Participation or consideration of participation in another biomedical study during the follow-up period of the present trial;
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Pregnant or lactating women;
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Serious heart, lung, hemorrhagic disease;
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Past psychiatric history; incapacitated or restricted;
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patient's condition increase the risk of receiving the drug treatment or confusion about the toxic reaction；
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Severe intolerance to the growth factor under study, or hypersensitivity to one of their components;
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the patients did not comply with the study;
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Other situation that investigators consider as contra-indication for this study.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Sun Yat-sen University
- Jiangsu HengRui Medicine Co., Ltd.
Investigators
- Principal Investigator: Huiqiang Huang, professor, Sun Yat-sen University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MA-ASCT-II-001