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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

485 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-22

Study Completion Date

2021-08-22

Brief Summary

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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.

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Detailed Description

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Conditions

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Elderly Lymphoma Patients

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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PEG-rhG-CSF

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.

Group Type EXPERIMENTAL

PEG-rhG-CSF

Intervention Type DRUG

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

Interventions

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PEG-rhG-CSF

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No