Clinical Study on PEG-rhG-CSF in Mobilizing Autologous Hematopoietic Stem Cells

Chongqing University Cancer Hospital

Status and phase: Enrolling; Phase 4

Conditions: Lymphoma

Treatments: Drug: RhG-CSF; Drug: PEG-rhG-CSF

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06026995

CSPC-JYL-PBSCT-02

Details and patient eligibility

About

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.

Enrollment: 174 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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174 participants in 2 patient groups

experimental group

Experimental group

Treatment:

Drug: PEG-rhG-CSF

control group

Active Comparator group

Treatment:

Drug: RhG-CSF