Cost-Effectiveness Study of PEG-rhG-CSF in Prophylactic Treatment of Neutropenia After Chemotherapy in Lymphoma

Last updated: September 5, 2019
Sponsor: Ruijin Hospital
Overall Status: Active - Recruiting

Phase

4

Condition

Lymphoma

Neutropenia

Treatment

N/A

Clinical Study ID

NCT04083079
PEG-rhG-CSF-01
  • Ages 18-65
  • All Genders

Study Summary

This is a pharmacoeconomic research to explore the cost-effectiveness of PEG-rhG-CSF and rhG-CSF in prophylactic treatment of neutropenia in lymphoma patients. It should provide more scientific basis for clinical decision-making.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 18-65 years

  • histologically confirmed de novo Non Hodgkin's lymphoma (except highly aggressivelymphoma such as lymphoblastic lymphoma and Burkitt lymphoma)

  • plan to be given 6-8 cycles of cyclophosphamide, doxorubicin, vincristine, andprednisone (CHOP) ± Rituximab (R)

  • KPS ≥70

  • plan continuous PEG-rhG-CSF or rhG-CSF adiministration after at least 3 cycles oftreatment for neutropenia prophylactic treatment

  • absolute neutrophil count≥1.5×109/L,platelet count ≥100× 109/L,hemoglobin≥90g/L,whileblood cell count≥3.0×109/L,without bleeding signs

  • adquate liver and renal function as protocol discribed

  • no serious cardiovascular disease as protocol discribed

  • under good mental conditions and informed consented

  • potential benefit for subjects based on investigators' decision

Exclusion

Exclusion Criteria:

  • history of hematopoetic stem cell transplantationor organ transplantation

  • uncontrollable infection

  • allergic to study drugs or ingredients

  • accepted any other investigational drug or participated another interventional studywithin 30 days during screening period

  • other uncontrollable conditions judged by the investigator

  • breast-feeding , pregnant or plan to be pregnant during study observation period

Study Design

Total Participants: 250
Study Start date:
August 01, 2019
Estimated Completion Date:
April 01, 2022

Connect with a study center

  • Ruijin hospital

    Shanghai, Shanghai 200025
    China

    Active - Recruiting

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