PEG-rhG-CSF Compared With rhG-CSF in Lymphoma Patients After Autologous Hematopoietic Stem Cell Transplantation
Primary Purpose
Lymphoma
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PEG-rhG-CSF
rhG-CSF
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PEG-rhG-CSF
rhG-CSF
Arm Description
Patients in PEG-rhG-CSF group received PEG-rhG-CSF day+1 after transplantation.
Patients in rhG-CSF group received rhG-CSF day+1 after transplantation.
Outcomes
Primary Outcome Measures
Time to neutrophil engraftment
Secondary Outcome Measures
The duration of neutrophilic granulocytopenia
Incidence of febrile neutrophilic granulocytopenia
Time to platelet engraftment and number of platelet transfused to the patient
Adverse Event
Safety
Full Information
NCT ID
NCT05156554
First Posted
December 12, 2021
Last Updated
December 13, 2021
Sponsor
Sun Yat-sen University
Collaborators
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05156554
Brief Title
PEG-rhG-CSF Compared With rhG-CSF in Lymphoma Patients After Autologous Hematopoietic Stem Cell Transplantation
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2021 (Anticipated)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
January 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
Collaborators
Jiangsu HengRui Medicine Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PEG-rhG-CSF
Arm Type
Experimental
Arm Description
Patients in PEG-rhG-CSF group received PEG-rhG-CSF day+1 after transplantation.
Arm Title
rhG-CSF
Arm Type
Active Comparator
Arm Description
Patients in rhG-CSF group received rhG-CSF day+1 after transplantation.
Intervention Type
Drug
Intervention Name(s)
PEG-rhG-CSF
Intervention Description
PEG-rhG-CSF was given day +1 after autologous stem cell transplantation with a dose of 6mg.
Intervention Type
Drug
Intervention Name(s)
rhG-CSF
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time to neutrophil engraftment
Time Frame
30 days
Secondary Outcome Measure Information:
Title
The duration of neutrophilic granulocytopenia
Time Frame
30 days
Title
Incidence of febrile neutrophilic granulocytopenia
Time Frame
30 days
Title
Time to platelet engraftment and number of platelet transfused to the patient
Time Frame
30 days
Title
Adverse Event
Description
Safety
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huiqiang Huang, professor
Phone
0086-13808885154
Email
huang_sysu@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huiqiang Huang, professor
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
PEG-rhG-CSF Compared With rhG-CSF in Lymphoma Patients After Autologous Hematopoietic Stem Cell Transplantation
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