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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lymphoma
• Intervention / Treatment: Drug: PEG-rhG-CSF; Drug: rhG-CSF

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Huiqiang Huang, professor; Phone Number: 0086-13808885154; Email: huang_sysu@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to neutrophil engraftment	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Safety	30 days

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Collaborators: Jiangsu HengRui Medicine Co., Ltd.
• Investigators: Principal Investigator: Huiqiang Huang, professor, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2021
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): January 1, 2023

Study Registration Dates

• First Submitted: December 12, 2021
• First Submitted That Met QC Criteria: December 13, 2021
• First Posted (Actual): December 14, 2021

Study Record Updates

• Last Update Posted (Actual): December 14, 2021
• Last Update Submitted That Met QC Criteria: December 13, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma
• Other Study ID Numbers: MA-ASCT-II-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No