Efficacy and Safety of PEG-rhG-CSF Injection for Neutrophil Reconstitution Following AHSCT in Lymphoma/Multiple Myeloma
Medical Professor,CHONGQING UNIVERSITY CANCER HOSPITAL
1 other identifier
interventional
7
1 country
1
Brief Summary
This study evaluates the effectiveness and safety of PEG-rhG-CSF injection for the reconstruction of neutrophil cells after autologous hematopoietic stem cell transplantation in lymphoma/multiple myeloma patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable lymphoma
Started Apr 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 22, 2022
CompletedFirst Submitted
Initial submission to the registry
September 4, 2023
CompletedFirst Posted
Study publicly available on registry
September 29, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2024
CompletedSeptember 29, 2023
September 1, 2023
1.7 years
September 4, 2023
September 23, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Median time to neutrophil cell reconstruction
day-based
0-21 days
Secondary Outcomes (4)
Blood Tests
30 days
Duration of absolute neutrophil count (ANC)
30 days
Number of days staying in the laminar flow ward after transplantation
30 days
Biochemical examination
30 days
Other Outcomes (3)
Usage of antibiotics, antifungal, or antiviral medications
100 days
Cost
100 days
Incidence of adverse events
100 days
Study Arms (1)
Clinical Study on PEG-rhG-CSF in the Treatment of Lymphoma/Multiple Myeloma
EXPERIMENTALIn this study, lymphoma/multiple myeloma patients who meet the inclusion criteria will be administered PEG-rhG-CSF injection at a fixed dose of 6 mg on the second day after hematopoietic stem cell infusion, and the effectiveness and safety of the treatment will be observed.
Interventions
Lymphoma/multiple myeloma patients who meet the inclusion criteria will be administered PEG-rhG-CSF injection at a fixed dose of 6 mg on the second day after hematopoietic stem cell infusion, and the effectiveness and safety of the treatment will be observed.
Eligibility Criteria
You may qualify if:
- Age 18-65, any gender;
- Patients with lymphoma/multiple myeloma requiring autologous hematopoietic stem cell transplantation;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 before transplantation;
- Basic normal function of heart, lungs, liver, and kidneys (no severe heart disease, no severe lung disease; transaminases ≤ 3× upper limit of normal, blood bilirubin ≤ 2.0 mg/dl; blood creatinine ≤ 2× upper limit of normal);
- Pre-transplant blood counts meet the following criteria: ANC (Absolute Neutrophil Count) ≥ 1.5×10\^9/L, HGB (Hemoglobin) ≥ 90g/L, PLT (Platelets) ≥ 100×10\^9/L;
- No other severe diseases that conflict with this protocol;
- Expected survival of ≥ 3 months and willingness to follow-up;
- Voluntary participation in this clinical trial and signing of informed consent;
- The investigator believes that the subject will benefit from participation.
You may not qualify if:
- Patients with splenomegaly;
- Individuals who have previously undergone allogeneic or autologous hematopoietic stem cell transplantation;
- HIV antibody-positive, HbsAg-positive, or HCV antibody-positive;
- Impaired liver or kidney function (transaminases \>3× ULN or blood bilirubin \>2.0 mg/dl; blood creatinine \>2× ULN);
- Decompensated heart failure, dilated cardiomyopathy, coronary artery disease with ST-segment depression on electrocardiogram, or myocardial infarction within the last Six months;
- Clinical symptoms of cognitive impairment or severe mental illness;
- Allergic reactions to polyethylene glycol recombinant human granulocyte colony-stimulating factor injection or recombinant human granulocyte colony-stimulating factor injection;
- Pregnant or breastfeeding women;
- Investigators believe participation in this clinical trial is unsuitable.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yao Liulead
Study Sites (1)
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, 400030, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 4, 2023
First Posted
September 29, 2023
Study Start
April 22, 2022
Primary Completion
December 31, 2023
Study Completion
April 30, 2024
Last Updated
September 29, 2023
Record last verified: 2023-09