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

NCT ID: NCT04497688

Last Updated: 2020-08-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2020-10-01

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

PEG-rhG-CSF

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hebei Medical University Fourth Hospital

OTHER

Sponsor Role: collaborator

CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lihong Liu, PHD

Role: PRINCIPAL_INVESTIGATOR

Hebei Medical University Fourth Hospital

Locations

The fourth hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Lihong Liu, PHD

Role: CONTACT

13831177920@163.com

86-13831177920

Facility Contacts

Lihong Liu, PHD

Role: primary

13831177920@163.com

86-13831177920

Other Identifiers

CSPC -JYL-NHL-03

Identifier Type: -

Identifier Source: org_study_id