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Evaluation of the Application of PEGylated Recombinant Human Granulocyte Stimulating Factor Injection (PEG-rhG-CSF) in Chemotherapy of Elderly Lymphoma Patients

Primary Purpose

Elderly Lymphoma Patients

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

PEG-rhG-CSF

About this trial

This is an interventional prevention trial for Elderly Lymphoma Patients focused on measuring PEG-rhG-CSF

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

(1) Age ≥ 65 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 % (see Annex I), or 10% <FN risk < 20% (see Annex II) with high risk factors for at least one FN;
(5) Physical status (KPS) score ≥ 70 points;
(6) Expected Survival period of more than 3 months;
(7) normal bone marrow hematopoietic function (ANC ≥1.5×109/L, PLT≥100×109/L, Hb≥80g/L, WBC≥3.0×109/L);
(8) 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) Insufficient local or systemic infection;
(4) Severe internal organ dysfunction and occurred in the last 6 months Myocardial infarction;
(5) Liver function tests total bilirubin (TBIL), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) are >2.5 times the upper limit of normal, if the above indicators are >5 times due to liver metastasis Upper limit of normal value; renal function test: serum creatinine (Cr) > 2 times the upper limit of normal;
(6) allergic 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) The investigator judges patients who are not suitable for participation.

Sites / Locations

Sun Yat-sen University Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PEG-rhG-CSF

Arm Description

Jin Youli(PEG-rhG-CSF):From the first cycle of chemotherapy, Jin Youli(PEG-rhG-CSF) was injected subcutaneously 24-72 hours after the end of chemotherapy, 6 mg was given to patients with body weight ≥45 kg, and 3 mg was given for body weight <45 kg. Inject once every chemotherapy cycle.

Outcomes

Primary Outcome Measures

Incidence of febrile neutropenia in cycles 1 to 6

The body temperature standard for neutropenic fever is sputum temperature; febrile neutropenia is defined as ANC < 0.5*109 / L and sputum temperature> 38.0 ° C.

Secondary Outcome Measures

The incidence of grade IV neutropenia in the first to sixth cycles of PEG-rhG-CSF.

Incidence of dose adjustment of chemotherapy drugs in each chemotherapy cycle

Incidence of chemotherapy delays in each chemotherapy cycle

The proportion of patients receiving antibiotics during the entire chemotherapy period.

Full Information

NCT ID

NCT03870412

First Posted

March 8, 2019

Last Updated

March 12, 2019

Sponsor

CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03870412

Brief Title

Evaluation of the Application of PEGylated Recombinant Human Granulocyte Stimulating Factor Injection (PEG-rhG-CSF) in Chemotherapy of Elderly Lymphoma Patients

Official Title

Multi-center, Open, One-arm Clinical Study Evaluating the Efficacy and Safety of Pegylated Recombinant Human Granulocyte-stimulating Factor Injection (PEG-rhG-CSF) in Preventing Neutropenia in Elderly Patients With Lymphoma After Chemotherapy

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Unknown status

Study Start Date

February 22, 2019 (Actual)

Primary Completion Date

March 22, 2021 (Anticipated)

Study Completion Date

August 22, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

A multicenter, open, one-arm clinical study evaluated the efficacy and safety of Jinyouli in preventing neutropenia after chemotherapy in elderly lymphoma patients who met the criteria for admission. Chemotherapy regimen: The investigator selected according to the specific condition the corresponding standard chemotherapy regimen, the chemotherapy regimen used, FN risk ≥ 20%, or 10% < FN risk < 20% with at least one high risk factor for FN, from the first cycle of chemotherapy, 24-72 after chemotherapy hour subcutaneous injection of Jinyouli.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Elderly Lymphoma Patients

Keywords

PEG-rhG-CSF

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

485 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PEG-rhG-CSF

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

PEG-rhG-CSF

Intervention Description

The test drug PEG-rhG-CSF was administered prophylactically to elderly lymphoma patients who met the inclusion/exclusion criteria 24-72 hours after chemotherapy.

Primary Outcome Measure Information:

Title

Incidence of febrile neutropenia in cycles 1 to 6

Description

The body temperature standard for neutropenic fever is sputum temperature; febrile neutropenia is defined as ANC < 0.5*109 / L and sputum temperature> 38.0 ° C.

Time Frame

through 1-6 cycles of PEG-rhG-CSF,an average of 6 month

Secondary Outcome Measure Information:

Title

The incidence of grade IV neutropenia in the first to sixth cycles of PEG-rhG-CSF.

Description

The incidence of grade IV neutropenia in the first to sixth cycles of PEG-rhG-CSF.

Time Frame

through 1-6 cycles of PEG-rhG-CSF,an average of 6 month

Title

Incidence of dose adjustment of chemotherapy drugs in each chemotherapy cycle

Description

Incidence of dose adjustment of chemotherapy drugs in each chemotherapy cycle

Time Frame

through 1-6 cycles of PEG-rhG-CSF,an average of 6 month

Title

Incidence of chemotherapy delays in each chemotherapy cycle

Description

Incidence of chemotherapy delays in each chemotherapy cycle

Time Frame

through 1-6 cycles of PEG-rhG-CSF,an average of 6 month

Title

The proportion of patients receiving antibiotics during the entire chemotherapy period.

Description

The proportion of patients receiving antibiotics during the entire chemotherapy period.

Time Frame

through 1-6 cycles of PEG-rhG-CSF,an average of 6 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: (1) Age ≥ 65 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 % (see Annex I), or 10% <FN risk < 20% (see Annex II) with high risk factors for at least one FN; (5) Physical status (KPS) score ≥ 70 points; (6) Expected Survival period of more than 3 months; (7) normal bone marrow hematopoietic function (ANC ≥1.5×109/L, PLT≥100×109/L, Hb≥80g/L, WBC≥3.0×109/L); (8) 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) Insufficient local or systemic infection; (4) Severe internal organ dysfunction and occurred in the last 6 months Myocardial infarction; (5) Liver function tests total bilirubin (TBIL), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) are >2.5 times the upper limit of normal, if the above indicators are >5 times due to liver metastasis Upper limit of normal value; renal function test: serum creatinine (Cr) > 2 times the upper limit of normal; (6) allergic 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) The investigator judges patients who are not suitable for participation.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Huiqiang Huang

Phone

13808885154

huanghq@sysucc.org.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Huiqiang Huang

Organizational Affiliation

Sun Yat-sen University Cancer Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sun Yat-sen University Cancer Hospital

City

Guangzhou

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Huiqiang Huang

Phone

13808885154

huanghq@sysucc.org.cn

12. IPD Sharing Statement

Learn more about this trial

Evaluation of the Application of PEGylated Recombinant Human Granulocyte Stimulating Factor Injection (PEG-rhG-CSF) in Chemotherapy of Elderly Lymphoma Patients

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