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

NCT05156554 | Unknown

• 1 other identifier: MA-ASCT-II-001
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lymphoma

Outcome Measures

Primary Outcomes (1)

• Time to neutrophil engraftment

  30 days

Secondary Outcomes (4)

• 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

  30 days

Study Arms (2)

PEG-rhG-CSF

EXPERIMENTAL

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

Drug: PEG-rhG-CSF

rhG-CSF

ACTIVE COMPARATOR

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

Drug: rhG-CSF

Interventions

PEG-rhG-CSF DRUG

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

PEG-rhG-CSF

rhG-CSF 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.

rhG-CSF

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%);
• Not in pregnancy; 9.Written informed consent are acquired.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

MeSH Terms

Conditions

Lymphoma

Interventions

pegylated granulocyte colony-stimulating factor

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Huiqiang Huang, professor

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huiqiang Huang, professor

CONTACT

0086-13808885154; huang_sysu@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 12, 2021
• First Posted: December 14, 2021
• Study Start: December 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: January 1, 2023
• Last Updated: December 14, 2021

Record last verified: 2021-12