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

Sponsor
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. (Industry)
Overall Status
Unknown status
CT.gov ID
NCT04497688
Collaborator
Hebei Medical University Fourth Hospital (Other)
104
1
1
21
5

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
104 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
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
Actual Study Start Date :
Jan 1, 2019
Anticipated Primary Completion Date :
Sep 1, 2020
Anticipated Study Completion Date :
Oct 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: PEG-rhG-CSF group

Patients received subcutaneous injection of PEG-rhG-CSF(Jinyouli®) 48 hours after the end of chemotherapy, 6mg for patients with body weight≥45kg and 3mg for patients with body weight less than 45kg, once per chemotherapy cycle

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.

Outcome Measures

Primary Outcome Measures

  1. The incidence of grade Ⅲ/Ⅳ neutropenia [From date of randomization until the date of the study completion,up to 24 weeks]

    Grade Ⅲ neutropenia is defined as ANC≥0.5×10^9/L, and <1×10^9/L; Grade Ⅳ neutropenia is defined as ANC<0.5×10^9/L

Secondary Outcome Measures

  1. Incidence of febrile neutropenia (FN) [From date of randomization until the date of the study completion,up to 24 weeks]

    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

  2. Antibiotic use rate [From date of randomization until the date of the study completion,up to 24 weeks]

    Antibiotic use rate during the treatment cycle

  3. Incidence of dose adjustment of chemotherapy or delay of chemotherapy [From date of randomization until the date of the study completion,up to 24 weeks]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 ≥1.5×109/L, PLT≥80×109/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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 The fourth hospital of Hebei Medical University Shijiazhuang Hebei China 050019

Sponsors and Collaborators

  • CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
  • Hebei Medical University Fourth Hospital

Investigators

  • Principal Investigator: Lihong Liu, PHD, The Fourth Hospital of Hebei Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT04497688
Other Study ID Numbers:
  • CSPC -JYL-NHL-03
First Posted:
Aug 4, 2020
Last Update Posted:
Aug 4, 2020
Last Verified:
Jul 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 4, 2020