An interventional study of pegylated recombinant human granulocyte-colony stimulating factor in Lymphoma and Multiple Myeloma, sponsored by Yao Liu. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-09-29.
Sponsored by Yao Liu · Not applicable, Interventional, and Treatment
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.
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 for the first time. After calculating the sample size, an initial cohort of 40 trial patients is expected to be enrolled. Patients meeting the eligibility criteria will be assigned to receive PEG-rhG-CSF treatment on the second day after hematopoietic stem cell infusion, with a fixed dose of 6 mg. The primary outcome measure of this study is the median time for neutrophil cell reconstruction. Secondary study endpoints include safety indicators of the medication, the duration of neutrophil cell reduction (ANC≤2.0×10\^9/L), the number of days patients spend in the laminar flow ward after transplantation, the usage of antibiotics, antifungal, or antiviral drugs, as well as patient expenditures, among other indicators.
Criteria for withdrawal/discontinuation of treatment:
(1) Subjects voluntarily request to withdraw from the trial;(2) Subjects who, although not explicitly requesting withdrawal from the trial, no longer adhere to the trial protocol for treatment and assessments, resulting in loss to follow-up; (3) Subjects with poor compliance who switch treatment regimens midway or use prohibited drugs within the protocol; (4) Subjects who were incorrectly enrolled; (5) Subjects experiencing intolerable allergic reactions or adverse events; (6) Subjects who pass away; (7) Other situations that meet the exclusion criteria arise.
Management of detachment cases:
When patients withdraw from the study due to allergic reactions or adverse events, researchers should take appropriate treatment measures based on the subject's condition. For mid-study withdrawal or loss to follow-up, researchers should actively take measures to complete the final assessment to analyze their efficacy and safety. All dropout cases should be documented in the case report form, and the trial conclusion form should be filled out along with the reasons for the subject dropout.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's planned enrollment of 7 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.
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Exclusion Criteria:
In 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.
Drug: pegylated recombinant human granulocyte-colony stimulating factor
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.
Also known as: PEG-rhG-CSF
Median time to neutrophil cell reconstruction
day-based
Time frame: 0-21 days
Blood Tests
Counts： red blood cells \[male:(4.3-5.8)×10¹²/L ),female:(3.8-5.1)×10¹²/L\]; white blood cells (3.5-9.5×10\^9/L); neutrophils (1.5\~8.0)×10\^9/L; lymphocytes (0.8-3.5)X10\^9/L; and platelets (100-300)×10\^9/L.
Time frame: 30 days
Duration of absolute neutrophil count (ANC)
The normal range for neutrophil count is approximately 1.8-6.3 x 10\^9/L. If the ANC (Absolute Neutrophil Count) falls to ≤2.0 x 10\^9/L, it is considered a possible side effect caused by the experimental drug used in this cancer patient.
Time frame: 30 days
Number of days staying in the laminar flow ward after transplantation
A laminar flow ward is used to prevent the risk of infection in patients undergoing their first autologous hematopoietic stem cell transplantation treatment.Typically, after receiving autologous hematopoietic stem cell transplantation treatment, patients reside in the Laminar flow ward for 1-3 months.
Time frame: 30 days
Biochemical examination
Alanine aminotransferase (0\~40U/L), glutamine aminotransferase(\<15U/L), alkaline phosphatase (40-150U/L) et al.
Time frame: 30 days
Usage of antibiotics, antifungal, or antiviral medications
It is primarily used to prevent infections in patients' bodies following autologous hematopoietic stem cell transplantation. Record the type and dosage of medication used.
Time frame: 100 days
Cost
The total treatment cost at the time of patient discharge. Usually denominated in RMB
Time frame: 100 days
Incidence of adverse events
lack of appetite, allergic reaction
Time frame: 100 days
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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