Lymphoma
Conditions
Brief summary
This study is a randomized controlled, open and multi-center clinical study. Patients who meet the selection criteria and do not meet the exclusion criteria are randomly given PEG-rhG-CSF with a fixed dose of 12mg when white blood cells reach the lowest point, or given rhG-CSF with a daily mobilization of 5-10μ g/kg until the collection is completed, so as to evaluate the effectiveness and safety of PEG-rhG-CSF in mobilizing autologous stem cells for lymphoma and multiple myeloma.
Interventions
DRUGPEG-rhG-CSF
Subcutaneous injection with a fixed dose of 12 mg
DRUGRhG-CSF
Inject rhG-CSF 5-10 μg/kg subcutaneously every day
Sponsors
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Chongqing University Cancer Hospital
Study design
Allocation
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. 18-65 years old, regardless of sex; 2. Patients with lymphoma and multiple myeloma who need autologous hematopoietic stem cell transplantation; 3. KPS score ≥70; 4. creatinine clearance rate ≥ 50mL/min, total bilirubin level \< 1.5mg/dL, ALT and AST \< 2 times the upper limit of normal value; 5. Absolute neutrophil count (ANC)≥1.5×109/L, platelet count ≥80×109/L, Hb≥ 75g/L, WBC ≥ 3.0× 109/L; 6. Patients can tolerate chemotherapy; 7. No active infection before chemotherapy; 8. The patient voluntarily participated in this trial and signed the informed consent form; 9. The researcher thinks that the subjects can benefit.
Exclusion criteria
1. Those who have previously received allogeneic or autologous hematopoietic stem cell transplantation; 2. Serious or uncontrolled virus infection: HIV, syphilis positive; 3. Severe dysfunction of internal organs; 4. severe mental or nervous system diseases; 5. allergic to PEG-rhG-CSF, rhG-CSF and other preparations or proteins expressed in Escherichia coli; 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 |
|---|---|---|
| The proportion of patients with CD34+ cells ≥2×106/kg | 28 days | The proportion of patients with CD34+ cells ≥2×106/kg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CD34+cell count | 28 days | CD34+cell count |
| Acquisition times | 28 days | The number of times a patient needs to collect a sufficient number of CD34+ cells |
| Mobilization time | 28 days | Time interval from mobilization to collection |
| Hematopoietic reconstruction time after transplantation | 3 months | Hematopoietic reconstruction time after transplantation |
| complication | 3 months | complication |
Countries
China
Contacts
Primary ContactYao Liu, doctor
Outcome results
None listed