the Efficacy and Safety of PEG-rhG-CSF in Mobilizing Autologous Hematopoietic Stem Cells in Lymphoma
- Registration Number
- NCT05834751
- Lead Sponsor
- Ou Bai, MD/PHD
- Brief Summary
A single center, non-inferiority, two-way cohort clinical study to evaluate the efficacy and safety of pegylated recombinant human granulocyte stimulating factor injection in the mobilization of autologous hematopoietic stem cells in lymphoma.
- Detailed Description
The objective was to to evaluate the efficacy and safety of pegylated recombinant human granulocyte stimulating factor injection in the mobilization of autologous hematopoietic stem cells in lymphoma.
lymphoma patients who need to be prepared for autologous hematopoietic stem cell transplantation; KPS score ≥70; Ccr≥ 50 mL/min, TBIL\< 25.65 umol/L, ALT and AST \< 2 times the upper limit of normal value;
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 144
- Age 18-65 years old, regardless of gender;
- lymphoma patients who need to be prepared for autologous hematopoietic stem cell transplantation;
- KPS score ≥70;
- Ccr≥ 50 mL/min, TBIL< 25.65 umol/L, ALT and AST < 2 times the upper limit of normal value;
- ANC ≥ 1.5×109/L，PLT ≥ 80×109/L，Hb ≥ 75g/L，WBC ≥ 3.0×109/L；
- Patients can tolerate chemotherapy；
- No active infection before chemotherapy;
- The retrospective enrolled subjects are exempted from informed consent for data collection, and the prospective enrolled subjects voluntarily participate in this experiment and sign the informed consent form;
- The researcher thinks that the subjects can benefit.
- Patients with megaspleen (when inhaling deeply, the spleen exceeds the right umbilicus and/or below the umbilical level);
- Those who have received mobilization and transplantation of allogeneic or autologous hematopoietic stem cells before;
- Subjects who have evidence of serious or uncontrollable systemic diseases (such as unstable or irreparable respiratory, heart, liver or kidney diseases) according to the researcher's judgment;
- severe mental or nervous system diseases;
- Those who are allergic to PEG-rhG-CSF, rhG-CSF and any active ingredients or auxiliary materials of other preparations expressed by Escherichia coli, or have a clear history of protein drug allergy, specific allergic reaction (asthma, rheumatism, eczema dermatitis) or have had other serious allergic reactions;
- pregnant or lactating female patients; Women of childbearing age refuse to accept contraceptive measures; Those who plan to become pregnant during the study period;
- The researcher judges other subjects who are not suitable to participate.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description experimental group PEG-rhG-CSF PEG-rhG-CSF control group RhG-CSF rhG-CSF
- Primary Outcome Measures
Name Time Method Mobilization success rate 48 months Accumulate CD34+cells ≥ 2×106/kg for 3 times or less
- Secondary Outcome Measures
Name Time Method Acquisition times 30 days Acquisition times
Speed of recovery 30 days The number of days when the leucocyte trough rose to the peak
Time of highest point of CD34+ cells 30 days Time of highest point of CD34+ cells
Single acquisition volume 30 days Single acquisition volume
White blood cell trough and peak 30 days The treatment period is from the beginning of chemotherapy to the end of collection, the trough value is recorded at the beginning of chemotherapy, and the peak value is recorded after PEG-rhG-CSF is applied
Administration times of rhG-CSF 30 days Administration times of rhG-CSF
Trial Locations
- Locations (1)
The First Bethune Hospital of Jilin University
🇨🇳Changchun, Jilin, China