Status:
UNKNOWN
Clinical Study on PEG-rhG-CSF in Mobilizing Autologous Hematopoietic Stem Cells
Lead Sponsor:
Chongqing University Cancer Hospital
Collaborating Sponsors:
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Conditions:
Lymphoma
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 18-65 years old, regardless of sex;
- Patients with lymphoma and multiple myeloma who need autologous hematopoietic stem cell transplantation;
- KPS score ≥70;
- creatinine clearance rate ≥ 50mL/min, total bilirubin level \< 1.5mg/dL, ALT and AST \< 2 times the upper limit of normal value;
- Absolute neutrophil count (ANC)≥1.5×109/L, platelet count ≥80×109/L, Hb≥ 75g/L, WBC ≥ 3.0× 109/L;
- Patients can tolerate chemotherapy;
- No active infection before chemotherapy;
- The patient voluntarily participated in this trial and signed the informed consent form;
- The researcher thinks that the subjects can benefit.
Exclusion
- Those who have previously received allogeneic or autologous hematopoietic stem cell transplantation;
- Serious or uncontrolled virus infection: HIV, syphilis positive;
- Severe dysfunction of internal organs;
- severe mental or nervous system diseases;
- allergic to PEG-rhG-CSF, rhG-CSF and other preparations or proteins expressed in Escherichia coli;
- 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.
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2024
Estimated Enrollment :
174 Patients enrolled
Trial Details
Trial ID
NCT06026995
Start Date
March 1 2022
End Date
June 1 2024
Last Update
September 7 2023
Active Locations (1)
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1
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China, 400030