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

NCT04497688 | Unknown

• 1 other identifier: CSPC -JYL-NHL-03
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non Hodgkin's Lymphoma

Outcome Measures

Primary Outcomes (1)

• The incidence of grade Ⅲ/Ⅳ neutropenia

  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 Outcomes (3)

• Incidence of febrile neutropenia (FN)

  From date of randomization until the date of the study completion，up to 24 weeks

• Antibiotic use rate

  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

  From date of randomization until the date of the study completion，up to 24 weeks

Study Arms (1)

PEG-rhG-CSF group

EXPERIMENTAL

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

Interventions

PEG-rhG-CSF DRUG

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.

PEG-rhG-CSF group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years, gender is not limited;
• Patients with lymphoma diagnosed by histopathology or cytology;
• Patients requiring multi-cycle chemotherapy;
• 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;
• Physical status (KPS) score ≥ 70 points;
• Expected Survival period of more than 3 months;
• 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);
• 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;
• Female patients of childbearing age must be negative in urine pregnancy test before treatment;
• The testers (or their legal representatives/guardians) must sign an informed consent form.

You may not qualify if:

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

Sponsors & Collaborators

• CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.: lead
• Hebei Medical University Fourth Hospital: collaborator

Study Sites (1)

The fourth hospital of Hebei Medical University

Shijiazhuang, Hebei, 050019, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

pegylated granulocyte colony-stimulating factor

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Lihong Liu, PHD

  Hebei Medical University Fourth Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lihong Liu, PHD

CONTACT

86-13831177920; 13831177920@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2020
• First Posted: August 4, 2020
• Study Start: January 1, 2019
• Primary Completion: September 1, 2020
• Study Completion: October 1, 2020
• Last Updated: August 4, 2020

Record last verified: 2020-07

Locations

CN (1)