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

Phase 4

Recruiting

• Conditions: Lymphoma
• Interventions: Drug: PEG-rhG-CSF; Drug: RhG-CSF

• Registration Number: NCT06026995
• Lead Sponsor: Chongqing University Cancer Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-01
• Status Verified: 2023-08
• Study First Submitted: 2023-08-31
• Study First Submitted QC: 2023-08-31
• Last Update Submitted: 2023-08-31
• Study First Posted: 2023-09-07
• Last Update Posted: 2023-09-07
• Primary Completion: 2024-01-01
• Study Completion: 2024-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 174

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental group	PEG-rhG-CSF	-
control group	RhG-CSF	-

Primary Outcome Measures

Name	Time	Method
The proportion of patients with CD34+ cells ≥2×106/kg	28 days	The proportion of patients with CD34+ cells ≥2×106/kg

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Chongqing University Cancer Hospital; 🇨🇳 Chongqing, Chongqing, China