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

NCT ID: NCT05156554

Last Updated: 2021-12-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-31
• Study Completion Date: 2023-01-31

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.

Conditions

Lymphoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PEG-rhG-CSF

Patients in PEG-rhG-CSF group received PEG-rhG-CSF day+1 after transplantation.

Group Type: EXPERIMENTAL

PEG-rhG-CSF

Intervention Type: DRUG

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

rhG-CSF

Patients in rhG-CSF group received rhG-CSF day+1 after transplantation.

Group Type: ACTIVE_COMPARATOR

rhG-CSF

Intervention Type: DRUG

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.

Interventions

PEG-rhG-CSF

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

Intervention Type: 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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Huiqiang Huang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Huiqiang Huang, professor

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Central Contacts

Huiqiang Huang, professor

Role: CONTACT

Phone: 0086-13808885154

Email: huang_sysu@163.com

Other Identifiers

MA-ASCT-II-001

Identifier Type: -

Identifier Source: org_study_id