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

NCT ID: NCT06026995

Last Updated: 2023-09-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 174 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2024-06-01

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.

Conditions

Lymphoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

experimental group

Group Type: EXPERIMENTAL

PEG-rhG-CSF

Intervention Type: DRUG

Subcutaneous injection with a fixed dose of 12 mg

control group

Group Type: ACTIVE_COMPARATOR

RhG-CSF

Intervention Type: DRUG

Inject rhG-CSF 5-10 μg/kg subcutaneously every day

Interventions

PEG-rhG-CSF

Subcutaneous injection with a fixed dose of 12 mg

Intervention Type: DRUG

RhG-CSF

Inject rhG-CSF 5-10 μg/kg subcutaneously every day

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Chongqing University Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yao Liu

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yao Liu, doctor

Role: CONTACT

64823926@qq.com

132 2868 4685

Facility Contacts

Yao Liu

Role: primary

64823926@qq.com

13228684685

Other Identifiers

CSPC-JYL-PBSCT-02

Identifier Type: -

Identifier Source: org_study_id