Efficacy and Safety of PEG-rhG-CSF Injection for Neutrophil Reconstitution Following AHSCT in Lymphoma/Multiple Myeloma

• Status: Recruiting
• Trial end date: 2024-04-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yao Liu
• Treatments: Lenograstim

Criteria

Inclusion Criteria:

1. Age 18-65, any gender;

2. Patients with lymphoma/multiple myeloma requiring autologous hematopoietic stem cell transplantation;

3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 before transplantation;

4. 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);

5. 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;

6. No other severe diseases that conflict with this protocol;

7. Expected survival of ≥ 3 months and willingness to follow-up;

8. Voluntary participation in this clinical trial and signing of informed consent;

9. The investigator believes that the subject will benefit from participation.

Exclusion Criteria:

1. Patients with splenomegaly;

2. Individuals who have previously undergone allogeneic or autologous hematopoietic stem cell transplantation;

3. HIV antibody-positive, HbsAg-positive, or HCV antibody-positive;

4. Impaired liver or kidney function (transaminases >3× ULN or blood bilirubin >2.0 mg/dl; blood creatinine >2× ULN);

5. Decompensated heart failure, dilated cardiomyopathy, coronary artery disease with ST-segment depression on electrocardiogram, or myocardial infarction within the last Six months;

6. Clinical symptoms of cognitive impairment or severe mental illness;

7. Allergic reactions to polyethylene glycol recombinant human granulocyte colony-stimulating factor injection or recombinant human granulocyte colony-stimulating factor injection;

8. Pregnant or breastfeeding women;

9. Investigators believe participation in this clinical trial is unsuitable.