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

• Sponsor: Chongqing University Cancer Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06026995
• Collaborator: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. (Industry)
• Enrollment: 174
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 27
• Patients Per Site Per Month: 6.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma	Drug: PEG-rhG-CSF; Drug: RhG-CSF	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 174 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical Study on the Effectiveness and Safety of PEG-rhG-CSF in Mobilizing Autologous Hematopoietic Stem Cells for Lymphoma and Multiple Myeloma
• Actual Study Start Date: Mar 1, 2022
• Anticipated Primary Completion Date: Jan 1, 2024
• Anticipated Study Completion Date: Jun 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. CD34+cell count [28 days]

   CD34+cell count

2. Acquisition times [28 days]

   The number of times a patient needs to collect a sufficient number of CD34+ cells

3. Mobilization time [28 days]

   Time interval from mobilization to collection

4. Hematopoietic reconstruction time after transplantation [3 months]

   Hematopoietic reconstruction time after transplantation

5. complication [3 months]

   complication

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chongqing University Cancer Hospital	Chongqing	Chongqing	China	400030

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yao Liu, Director, Chongqing University Cancer Hospital
• ClinicalTrials.gov Identifier: NCT06026995
• Other Study ID Numbers: CSPC-JYL-PBSCT-02
• First Posted: Sep 7, 2023
• Last Update Posted: Sep 7, 2023
• Last Verified: Aug 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lymphoma

Study Results

No Results Posted as of Sep 7, 2023