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

August 2, 2020 updated by: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

104

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hebei
      • Shijiazhuang, Hebei, China, 050019
        • Recruiting
        • The Fourth Hospital of Hebei Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PEG-rhG-CSF group
Patients received subcutaneous injection of PEG-rhG-CSF(Jinyouli®) 48 hours after the end of chemotherapy, 6mg for patients with body weight≥45kg and 3mg for patients with body weight less than 45kg, once per chemotherapy cycle
Drug: PEG-rhG-CSF
Patients received a single dose of PEG-rhG-CSF per cycle. The chemotherapy regimen must meet the interval between two chemotherapy sessions at least 12 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of grade Ⅲ/Ⅳ neutropenia
Time Frame: From date of randomization until the date of the study completion，up to 24 weeks
Grade Ⅲ neutropenia is defined as ANC≥0.5×10^9/L, and <1×10^9/L; Grade Ⅳ neutropenia is defined as ANC<0.5×10^9/L
From date of randomization until the date of the study completion，up to 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of febrile neutropenia (FN)
Time Frame: From date of randomization until the date of the study completion，up to 24 weeks
A single oral temperature is 38.3℃ or ≥38℃ for more than 1 h, and the absolute value of neutrophils is less than 0.5×10^9/L or the absolute value of neutrophils is less than 1.0×10^9/L but it is expected to drop to less than 0.5×10^9/L within 48 hours
From date of randomization until the date of the study completion，up to 24 weeks
Antibiotic use rate
Time Frame: From date of randomization until the date of the study completion，up to 24 weeks
Antibiotic use rate during the treatment cycle
From date of randomization until the date of the study completion，up to 24 weeks
Incidence of dose adjustment of chemotherapy or delay of chemotherapy
Time Frame: From date of randomization until the date of the study completion，up to 24 weeks
Dose adjustment is defined as the reduction of planned dose of chemotherapy; Chemotherapy delay is defined as the delay in starting the next planned chemotherapy for more than 3 days.
From date of randomization until the date of the study completion，up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

Collaborators

Hebei Medical University Fourth Hospital

Investigators

  • Principal Investigator: Lihong Liu, PHD, The Fourth Hospital of Hebei Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Anticipated)

September 1, 2020

Study Completion (Anticipated)

October 1, 2020

Study Registration Dates

First Submitted

July 27, 2020

First Submitted That Met QC Criteria

August 2, 2020

First Posted (Actual)

August 4, 2020

Study Record Updates

Last Update Posted (Actual)

August 4, 2020

Last Update Submitted That Met QC Criteria

August 2, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSPC -JYL-NHL-03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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