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

Non Hodgkin's Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04497688
• Other study ID #: CSPC -JYL-NHL-03
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: October 1, 2020

Study information

• Verified date: July 2020
• Source: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
• Contact: Lihong Liu, PHD
• Phone: 86-13831177920
• Email: 13831177920[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 104
• Est. completion date: October 1, 2020
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Neutropenia
• Non Hodgkin's Lymphoma

Intervention

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.

Locations

Country	Name	City	State
China	The fourth hospital of Hebei Medical University	Shijiazhuang	Hebei

Sponsors (2)

Lead Sponsor	Collaborator
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.	Hebei Medical University Fourth Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of grade ?/? neutropenia	Grade ? neutropenia is defined as ANC=0.5×10^9/L, and <1×10^9/L; Grade ? 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	Incidence of febrile neutropenia (FN)	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
Secondary	Antibiotic use rate	Antibiotic use rate during the treatment cycle	From date of randomization until the date of the study completion,up to 24 weeks
Secondary	Incidence of dose adjustment of chemotherapy or delay of chemotherapy	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