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Evaluate the Efficacy and Safety of PEG-rhG-CSF in Preventing Neutropenia After Chemotherapy in Patients With Non-Hodgkin's Lymphoma | Clinical Trials | Clareo Health

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Evaluate the Efficacy and Safety of PEG-rhG-CSF in Preventing Neutropenia After Chemotherapy in Patients With Non-Hodgkin's Lymphoma

A Multi-center, Open-label, Single-arm Study to Evaluate the Efficacy and Safety of PEG-rhG-CSF(Jinyouli®) in Preventing Neutropenia After Chemotherapy in Patients With Non-Hodgkin's Lymphoma

NCT04497688•CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

The main treatments for non-Hodgkin's lymphoma are surgery, radiotherapy, chemotherapy, and bone marrow transplantation. Neutropenia is the most common and serious complication of most chemotherapy. This study is a multi-center, open-label, single-arm clinical study to evaluate the efficacy and safety of jinyouli in preventing neutropenia in patients with non Hodgkin's lymphoma after chemotherapy.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age ≥ 18 years, gender is not limited;
•2. Patients with lymphoma diagnosed by histopathology or cytology;
•3. Patients requiring multi-cycle chemotherapy;
•4. Planned chemotherapy regimen FN risk ≥ 20 % , or 10% \<FN risk \< 20% with high risk factors ; According to the judgment of the investigator, there is a risk of FN occurrence if G-CSF support is not accepted, PEG-rhG-CSF should be used prophylactically from the first cycle;
•5. Physical status (KPS) score ≥ 70 points;
•6. Expected Survival period of more than 3 months;
•7. Normal bone marrow hematopoietic function (ANC ≥1.5×10\^9/L, PLT≥80×10\^9/L, Hb≥75g/L, WBC≥3.0×10\^9/L);
•8. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)≤2.5 times the upper limit of normal value, or≤5 times the upper limit of normal value when there is liver metastasis; total bilirubin (TBIL)≤2.5 times the upper limit of normal value; serum creatinine (Cr)≤2 times the upper limit of normal value;
•9. Female patients of childbearing age must be negative in urine pregnancy test before treatment;
•10. The testers (or their legal representatives/guardians) must sign an informed consent form.

Exclusion Criteria

•1. Lymphoma central involvement;
•2. Hematopoietic stem cell transplantation or organ transplantation;
•3. Local or systemic infection without adequate control;
•4. Severe internal organ dysfunction and occurred in the last 6 months Myocardial infarction;
•5. Those who used other test drugs of the same kind or accepted other clinical trials within 4 weeks before enrollmen；
•6. Allergy to PEG-rhG-CSF, rhG-CSF and other preparations or proteins expressed by Escherichia coli;
•7. Severe mental illness, affecting informed consent and/or adverse reaction expression or observation;
•8. Pregnant or lactating female patients; women who refuse to accept contraceptive measures ;
•9. Researchers determine unsuited to participate in this trial.

Locations (1)

The fourth hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Key Dates

Start Date

January 1, 2019

Primary Completion Date

September 1, 2020

Completion Date

October 1, 2020

Last Updated

August 4, 2020

Enrollment

104

ESTIMATED participants

Conditions

Non Hodgkin's Lymphoma

Interventions

PEG-rhG-CSF

DRUG

Contacts

Lihong Liu, PHD

CONTACT

86-13831177920 13831177920@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: August 4, 2020Data 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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Evaluate the Efficacy and Safety of PEG-rhG-CSF in Preventing Neutropenia After Chemotherapy in Patients With Non-Hodgkin's Lymphoma

Inclusion Criteria

Exclusion Criteria

Study for Subjects With Relapsed/Refractory Non- Hodgkin Lymphoma

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