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

Lymphoma Clinical Trial

Official title:

Clinical Study on the Effectiveness and Safety of PEG-rhG-CSF in Mobilizing Autologous Hematopoietic Stem Cells for Lymphoma and Multiple Myeloma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06026995
• Other study ID #: CSPC-JYL-PBSCT-02
• Status: Recruiting
• Phase: Phase 4
• Start date: March 1, 2022
• Est. completion date: June 1, 2024

Study information

• Verified date: August 2023
• Source: Chongqing University Cancer Hospital
• Contact: Yao Liu, doctor
• Phone: 132 2868 4685
• Email: 64823926[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 174
• Est. completion date: June 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma

Intervention

Drug:
• PEG-rhG-CSF
Subcutaneous injection with a fixed dose of 12 mg
• RhG-CSF
Inject rhG-CSF 5-10 µg/kg subcutaneously every day

Locations

Country	Name	City	State
China	Chongqing University Cancer Hospital	Chongqing	Chongqing

Sponsors (2)

Lead Sponsor	Collaborator
Chongqing University Cancer Hospital	CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of patients with CD34+ cells =2×106/kg	The proportion of patients with CD34+ cells =2×106/kg	28 days
Secondary	CD34+cell count	CD34+cell count	28 days
Secondary	Acquisition times	The number of times a patient needs to collect a sufficient number of CD34+ cells	28 days
Secondary	Mobilization time	Time interval from mobilization to collection	28 days
Secondary	Hematopoietic reconstruction time after transplantation	Hematopoietic reconstruction time after transplantation	3 months
Secondary	complication	complication	3 months