Status:
UNKNOWN
Efficacy and Safety of PEG-rhG-CSF Injection for Neutrophil Reconstitution Following AHSCT in Lymphoma/Multiple Myeloma
Lead Sponsor:
Yao Liu
Conditions:
Lymphoma
Multiple Myeloma
Eligibility:
All Genders
18-65 years
Phase:
NA
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 myel...
Detailed Description
This study is a single-center, open-label clinical trial. Inclusion criteria involve patients with confirmed lymphoma or multiple myeloma receiving autologous hematopoietic stem cell transplantation f...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2024
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT06060080
Start Date
April 22 2022
End Date
April 30 2024
Last Update
September 29 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China, 400030