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

NCT06026995 | Unknown Phase 4 DMC

• 1 other identifier: CSPC-JYL-PBSCT-02
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• The proportion of patients with CD34+ cells ≥2×106/kg

  The proportion of patients with CD34+ cells ≥2×106/kg

  28 days

Secondary Outcomes (5)

• CD34+cell count

  28 days

• Acquisition times

  28 days

• Mobilization time

  28 days

• Hematopoietic reconstruction time after transplantation

  3 months

• complication

  3 months

Study Arms (2)

experimental group

EXPERIMENTAL

Drug: PEG-rhG-CSF

control group

ACTIVE COMPARATOR

Drug: RhG-CSF

Interventions

PEG-rhG-CSF DRUG

Subcutaneous injection with a fixed dose of 12 mg

experimental group

RhG-CSF DRUG

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

control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chongqing University Cancer Hospital: lead
• CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, 400030, China

RECRUITING

MeSH Terms

Conditions

Lymphoma

Interventions

pegylated granulocyte colony-stimulating factor

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Yao Liu, doctor

CONTACT

132 2868 4685; 64823926@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: August 31, 2023
• First Posted: September 7, 2023
• Study Start: March 1, 2022
• Primary Completion: January 1, 2024
• Study Completion: June 1, 2024
• Last Updated: September 7, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)