Clinical trial NCT05156554: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Lymphoma
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Jiangsu HengRui Medicine Co., Ltd.
First posted: 2021-12-14
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Patients with age between 18 and 65 years;
2. hematopoietic stem cell transplantation for the first time;
3. Lymphoma patients with the requirement for autologous;
4. ECOG score ≤2;
5. Estimated survival time \> 3 months;
6. 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:

1. Had received autologous hematopoietic stem cell transplantation or allogeneic transplantation;
2. bone marrow involvement;
3. Patients with active autoimmune diseases requiring systematic treatment were excluded according to the clinical judgment of the investigators;
4. Patients with active infections requiring systematic treatment were excluded according to the clinical judgment of the investigators;
5. Serious complications, such as severe infection, heart, lung, liver and kidney dysfunction；
6. patients in fever of unknown origin before medication（\>38℃）；
7. central nervous system involvement;
8. Patients that received pelvic radiotherapy;
9. patients will received Chemotherapy or radiotherapy under the diaphragm after transplantation ；
10. Participation or consideration of participation in another biomedical study during the follow-up period of the present trial;
11. Pregnant or lactating women;
12. Serious heart, lung, hemorrhagic disease;
13. Past psychiatric history; incapacitated or restricted;
14. patient's condition increase the risk of receiving the drug treatment or confusion about the toxic reaction；
15. Severe intolerance to the growth factor under study, or hypersensitivity to one of their components;
16. the patients did not comply with the study;
17. Other situation that investigators consider as contra-indication for this study.

Primary outcomes:
measure: Time to neutrophil engraftment
timeFrame: 30 days
Secondary outcomes:
measure: The duration of neutrophilic granulocytopenia
timeFrame: 30 days
measure: Incidence of febrile neutrophilic granulocytopenia
timeFrame: 30 days
measure: Time to platelet engraftment and number of platelet transfused to the patient
timeFrame: 30 days
measure: Adverse Event
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
affiliation: Sun Yat-sen University
name: Huiqiang Huang, professor
role: PRINCIPAL_INVESTIGATOR
References: