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

Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05156554
• Other study ID #: MA-ASCT-II-001
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2021
• Est. completion date: January 2023

Study information

• Verified date: December 2021
• Source: Sun Yat-sen University
• Contact: Huiqiang Huang, professor
• Phone: 0086-13808885154
• Email: huang_sysu[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: January 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma

Intervention

Drug:
• PEG-rhG-CSF
PEG-rhG-CSF was given day +1 after autologous stem cell transplantation with a dose of 6mg.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Sun Yat-sen University	Jiangsu HengRui Medicine Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to neutrophil engraftment		30 days
Secondary	The duration of neutrophilic granulocytopenia		30 days
Secondary	Incidence of febrile neutrophilic granulocytopenia		30 days
Secondary	Time to platelet engraftment and number of platelet transfused to the patient		30 days
Secondary	Adverse Event	Safety	30 days