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

Sponsor
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. (Industry)
Overall Status
Unknown status
CT.gov ID
NCT03870412
Collaborator
(none)
485
1
1
30
16.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Anticipated 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 :
Feb 22, 2019
Anticipated Primary Completion Date :
Mar 22, 2021
Anticipated Study Completion Date :
Aug 22, 2021

Arms and Interventions

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

Primary Outcome Measures

  1. Incidence of febrile neutropenia in cycles 1 to 6 [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. [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 [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 [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. [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

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Sun Yat-sen University Cancer Hospital Guangzhou China

Sponsors and Collaborators

  • CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

Investigators

  • Principal Investigator: Huiqiang Huang, Sun Yat-sen University Cancer Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT03870412
Other Study ID Numbers:
  • CSPC-JYL-LY-03
First Posted:
Mar 12, 2019
Last Update Posted:
Mar 14, 2019
Last Verified:
Feb 1, 2019
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.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 14, 2019