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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Lymphoma
• Intervention / Treatment: Drug: PEG-rhG-CSF; Drug: RhG-CSF

• Study Type: Interventional
• Enrollment (Estimated): 174
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Yao Liu, doctor; Phone Number: 132 2868 4685; Email: 64823926@qq.com

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400030
      • Recruiting
      • Chongqing University Cancer Hospital
      • Contact: Yao Liu; Phone Number: 13228684685; Email: 64823926@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental group	Drug: PEG-rhG-CSF; Subcutaneous injection with a fixed dose of 12 mg
Active Comparator: control group	Drug: RhG-CSF; Inject rhG-CSF 5-10 μg/kg subcutaneously every day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of patients with CD34+ cells ≥2×106/kg	The proportion of patients with CD34+ cells ≥2×106/kg	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CD34+cell count	CD34+cell count	28 days
Acquisition times	The number of times a patient needs to collect a sufficient number of CD34+ cells	28 days
Mobilization time	Time interval from mobilization to collection	28 days
Hematopoietic reconstruction time after transplantation	Hematopoietic reconstruction time after transplantation	3 months
complication	complication	3 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Estimated): January 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: August 31, 2023
• First Submitted That Met QC Criteria: August 31, 2023
• First Posted (Actual): September 7, 2023

Study Record Updates

• Last Update Posted (Actual): September 7, 2023
• Last Update Submitted That Met QC Criteria: August 31, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma
• Other Study ID Numbers: CSPC-JYL-PBSCT-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No