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the Efficacy and Safety of PEG-rhG-CSF in Mobilizing Autologous Hematopoietic Stem Cells in Lymphoma | Clinical Trials | Clareo Health

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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.

NCT05834751•Ou Bai, MD/PHD

View on ClinicalTrials.gov

Summary

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.

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;

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

The First Bethune Hospital of Jilin University

Changchun, Jilin, China

Key Dates

Start Date

May 1, 2023

Primary Completion Date

May 1, 2025

Completion Date

July 1, 2025

Last Updated

April 28, 2023

Enrollment

144

ESTIMATED participants

Conditions

Lymphoma

Interventions

PEG-rhG-CSF

DRUG

RhG-CSF

DRUG

Contacts

Ou Bai, doctor

CONTACT

13039046656 oubai16@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 28, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

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Exclusion Criteria

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