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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

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ClinicalTrials.gov Identifier: NCT03870412
Recruitment Status : Unknown
Verified February 2019 by CSPC Baike (Shandong) Biopharmaceutical Co., Ltd..
Recruitment status was:  Recruiting
First Posted : March 12, 2019
Last Update Posted : March 14, 2019
Sponsor:
Information provided by (Responsible Party):
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Elderly Lymphoma Patients Drug: PEG-rhG-CSF Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 485 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : February 22, 2019
Estimated Primary Completion Date : March 22, 2021
Estimated Study Completion Date : August 22, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Drug: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of febrile neutropenia in cycles 1 to 6 [ Time Frame: through 1-6 cycles of PEG-rhG-CSF,an average of 6 month ]
    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 :
  1. 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 ]
    The incidence of grade IV neutropenia in the first to sixth cycles of PEG-rhG-CSF.

  2. 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 ]
    Incidence of dose adjustment of chemotherapy drugs in each chemotherapy cycle

  3. Incidence of chemotherapy delays in each chemotherapy cycle [ Time Frame: through 1-6 cycles of PEG-rhG-CSF,an average of 6 month ]
    Incidence of chemotherapy delays in each chemotherapy cycle

  4. 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 ]
    The proportion of patients receiving antibiotics during the entire chemotherapy period.


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03870412


Contacts
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Contact: Huiqiang Huang 13808885154 huanghq@sysucc.org.cn

Locations
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China
Sun Yat-sen University Cancer Hospital Recruiting
Guangzhou, China
Contact: Huiqiang Huang    13808885154    huanghq@sysucc.org.cn   
Sponsors and Collaborators
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Investigators
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Principal Investigator: Huiqiang Huang Sun Yat-sen University Cancer Hospital
More Information
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Responsible Party: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT03870412    
Other Study ID Numbers: CSPC-JYL-LY-03
First Posted: March 12, 2019    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.:
PEG-rhG-CSF
Additional relevant MeSH terms:
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Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
 Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases