Lymphoma
Conditions
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;
Interventions
DRUGPEG-rhG-CSF
48-72 hours after chemotherapy,9 mg of PEG-rhG-CSF was injected subcutaneously for mobilization
DRUGRhG-CSF
After clinical evaluation, rhG-CSF was given 10μ g/kg/d for mobilization until the stem cell collection was completed.
Sponsors
Ou Bai, MD/PHD
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-65 years old, regardless of gender; 2. lymphoma patients who need to be prepared for autologous hematopoietic stem cell transplantation; 3. KPS score ≥70; 4. Ccr≥ 50 mL/min, TBIL\< 25.65 umol/L, ALT and AST \< 2 times the upper limit of normal value; 5. ANC ≥ 1.5×109/L，PLT ≥ 80×109/L，Hb ≥ 75g/L，WBC ≥ 3.0×109/L； 6. Patients can tolerate chemotherapy； 7. No active infection before chemotherapy; 8. 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; 9. The researcher thinks that the subjects can benefit.
Exclusion criteria
1. Patients with megaspleen (when inhaling deeply, the spleen exceeds the right umbilicus and/or below the umbilical level); 2. Those who have received mobilization and transplantation of allogeneic or autologous hematopoietic stem cells before; 3. 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; 4. severe mental or nervous system diseases; 5. 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; 6. pregnant or lactating female patients; Women of childbearing age refuse to accept contraceptive measures; Those who plan to become pregnant during the study period; 7. The researcher judges other subjects who are not suitable to participate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mobilization success rate | 48 months | Accumulate CD34+cells ≥ 2×106/kg for 3 times or less |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Administration times of rhG-CSF | 30 days | Administration times of rhG-CSF |
| 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 |
| Acquisition times | 30 days | Acquisition times |
| Time of highest point of CD34+ cells | 30 days | Time of highest point of CD34+ cells |
| Single acquisition volume | 30 days | Single acquisition volume |
| Speed of recovery | 30 days | The number of days when the leucocyte trough rose to the peak |
Countries
China
Contacts
Primary ContactOu Bai, doctor
Outcome results
None listed