PEG-rhG-CSF in Patients With Non-Hodgkin Lymphoma Receiving Chemotherapy to Prevent Neutropenia

Last updated: December 15, 2016
Sponsor: Shandong Provincial Hospital
Overall Status: Trial Status Unknown

Phase

4

Condition

Lymphoma

Neutropenia

Treatment

N/A

Clinical Study ID

NCT02996617
ShandongPH02
  • Ages 18-80
  • All Genders

Study Summary

Neutropenia is one of the most frequent adverse effects of chemotherapy, and the main factor to limit the dosage and the continuation of chemotherapy. The PEG-rhG-CSF has increased plasma half-life, and prolonged efficacy in compare with rhG-CSF. The purpose of this study is to determine the safety and effectiveness of PEG-rhG-CSF in preventing neutropenia following chemotherapy in patients with non-Hodgkin lymphoma.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Investigator diagnosis of non-Hodgkin lymphoma(Highly invasive lymphoma/Burkittlymphoma were excluded)

  • Age 18 to 80 years

  • ECOG performance status ≤ 2

  • receive multi-cycle Chemotherapy naive

  • grade 3/4 neutropenia occurred in the patient's first cycle chemotherapy or the riskof neutropenia ＞20% without rhG-CSF support

  • Expected survival time≥3 months; cNormal bone marrow function(absolute neutrophilcount ≥1.5 × 109/L; platelet count ≥ 80 × 109/L)

  • Liver function: transaminase≤2.5× upper limit of normal value，bilirubin≤2.5×upperlimit of normal value; serum creatinine≤2×upper limit of normal value;

Exclusion

Exclusion Criteria:

  • Patients with severe complications or severe infection;

  • Invasion of central nervous system;

  • Patients with severe visceral organ dysfunction, heart block, myocardial infarctionwithin 6 months;

  • Prior bone marrow stem cell or organ transplantation

  • patients with severe allergic constitution, or those who are allergic to Escherichiacoli products; 5. Patients participate in other clinical studies within 4 weeks;

  • Pregnancy, lactation

  • Other patients who are not suitable for the study.

Study Design

Total Participants: 240
Study Start date:
November 01, 2016
Estimated Completion Date:
December 31, 2018

Study Description

Neutropenia is a common clinical complication of chemotherapy in cancer patients. It is an important factor that delays the course of standard treatments in patients. Recombinant human granulocyte colony-stimulating factor (rhG-CSF) is an effective drug for the treatment of chemotherapy-induced neutropenia. However, for patients with neutropenia, multiple rhG-CSF treatments are usually required. This is likely to extend the antitumor treatment period and increase physical and mental stress in patients. Pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF) is rhG-CSF chemically modified by a single methoxy polyethylene glycol group; it is able to alleviate neutropenia with a single dose. The aim of the present study was to determine the safety and effectiveness of preventive treatment with pegylated recombinant human granulocyte colony stimulating factor (PEG-rhG-CSF) on concurrent chemotherapy-induced neutropenia and to provide a rational basis for its clinical application. Therefore, the investigators designed the multi-center, open-label,randomized controlled clinical study and aimed to compare the efficacy and safety between PEG-rhG-CSF and rhG-CSF in non-Hodgkin lymphoma receiving chemotherapy.

Connect with a study center

  • Department of Hematology, Provincial Hospital Affiliated to Shandong University

    Jin'an, Shandong 250012
    China

    Active - Recruiting

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