the Efficacy and Safety of PEG-rhG-CSF in Mobilizing Autologous Hematopoietic Stem Cells in Lymphoma

Clinical Study on the Effectiveness and Safety of Pegylated Recombinant Human Granulocyte Stimulating Factor Injection and PEG-rhG-CSF in Mobilizing Autologous Hematopoietic Stem Cells in Lymphoma.

A single center, non-inferiority, two-way cohort clinical study to evaluate the efficacy and safety of pegylated recombinant human granulocyte stimulating factor injection in the mobilization of autologous hematopoietic stem cells in lymphoma.

Study Overview

• Status: Not yet recruiting
• Conditions: Lymphoma
• Intervention / Treatment: Drug: PEG-rhG-CSF; Drug: RhG-CSF

Detailed Description

The objective was to to evaluate the efficacy and safety of pegylated recombinant human granulocyte stimulating factor injection in the mobilization of autologous hematopoietic stem cells in lymphoma.

lymphoma patients who need to be prepared for autologous hematopoietic stem cell transplantation; KPS score ≥70; Ccr≥ 50 mL/min, TBIL< 25.65 umol/L, ALT and AST < 2 times the upper limit of normal value;

• Study Type: Interventional
• Enrollment (Anticipated): 144
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China, 130021
      • The First Bethune Hospital of Jilin University
      • Contact: Ou Bai, doctor; Phone Number: 13039046656; Email: oubai@163.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Age 18-65 years old, regardless of gender;
2. lymphoma patients who need to be prepared for autologous hematopoietic stem cell transplantation;
3. KPS score ≥70;
4. Ccr≥ 50 mL/min, TBIL< 25.65 umol/L, ALT and AST < 2 times the upper limit of normal value;
5. ANC ≥ 1.5×109/L，PLT ≥ 80×109/L，Hb ≥ 75g/L，WBC ≥ 3.0×109/L；
6. Patients can tolerate chemotherapy；
7. No active infection before chemotherapy;
8. The retrospective enrolled subjects are exempted from informed consent for data collection, and the prospective enrolled subjects voluntarily participate in this experiment and sign the informed consent form;
9. The researcher thinks that the subjects can benefit.

Exclusion Criteria:

1. Patients with megaspleen (when inhaling deeply, the spleen exceeds the right umbilicus and/or below the umbilical level);
2. Those who have received mobilization and transplantation of allogeneic or autologous hematopoietic stem cells before;
3. Subjects who have evidence of serious or uncontrollable systemic diseases (such as unstable or irreparable respiratory, heart, liver or kidney diseases) according to the researcher's judgment;
4. severe mental or nervous system diseases;
5. Those who are allergic to PEG-rhG-CSF, rhG-CSF and any active ingredients or auxiliary materials of other preparations expressed by Escherichia coli, or have a clear history of protein drug allergy, specific allergic reaction (asthma, rheumatism, eczema dermatitis) or have had other serious allergic reactions;
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: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental group; PEG-rhG-CSF	Drug: PEG-rhG-CSF; 48-72 hours after chemotherapy,9 mg of PEG-rhG-CSF was injected subcutaneously for mobilization; Other Names: pegfilgrastim
Active Comparator: control group; rhG-CSF	Drug: RhG-CSF; After clinical evaluation, rhG-CSF was given 10μ g/kg/d for mobilization until the stem cell collection was completed.; Other Names: filgrastim

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mobilization success rate	Accumulate CD34+cells ≥ 2×106/kg for 3 times or less	48 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
White blood cell trough and peak	The treatment period is from the beginning of chemotherapy to the end of collection, the trough value is recorded at the beginning of chemotherapy, and the peak value is recorded after PEG-rhG-CSF is applied	30 days
Speed of recovery	The number of days when the leucocyte trough rose to the peak	30 days
Time of highest point of CD34+ cells	Time of highest point of CD34+ cells	30 days
Single acquisition volume	Single acquisition volume	30 days
Acquisition times	Acquisition times	30 days
Administration times of rhG-CSF	Administration times of rhG-CSF	30 days

Collaborators and Investigators

• Sponsor: Ou Bai, MD/PHD
• Investigators: Principal Investigator: Ou Bai, doctor, The First Hospital of Jilin University

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2023
• Primary Completion (Anticipated): May 1, 2025
• Study Completion (Anticipated): July 1, 2025

Study Registration Dates

• First Submitted: April 6, 2023
• First Submitted That Met QC Criteria: April 18, 2023
• First Posted (Actual): April 28, 2023

Study Record Updates

• Last Update Posted (Actual): April 28, 2023
• Last Update Submitted That Met QC Criteria: April 18, 2023
• Last Verified: April 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-03A

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