Status:
UNKNOWN
Cost-Effectiveness Study of PEG-rhG-CSF in Prophylactic Treatment of Neutropenia After Chemotherapy in Lymphoma
Lead Sponsor:
Ruijin Hospital
Conditions:
Lymphoma, Non-Hodgkin
Granulocyte Colony-Stimulating Factor
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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 ...
Eligibility Criteria
Inclusion
- 18-65 years
- histologically confirmed de novo Non Hodgkin's lymphoma (except highly aggressive lymphoma such as lymphoblastic lymphoma and Burkitt lymphoma)
- plan to be given 6-8 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) ± Rituximab (R)
- KPS ≥70
- plan continuous PEG-rhG-CSF or rhG-CSF adiministration after at least 3 cycles of treatment for neutropenia prophylactic treatment
- absolute neutrophil count≥1.5×109/L，platelet count ≥100× 109/L，hemoglobin≥90g/L，while blood 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
- 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 study within 30 days during screening period
- other uncontrollable conditions judged by the investigator
- breast-feeding , pregnant or plan to be pregnant during study observation period
Key Trial Info
Start Date :
August 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2022
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT04083079
Start Date
August 1 2019
End Date
April 1 2022
Last Update
September 10 2019
Active Locations (1)
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1
Ruijin hospital
Shanghai, Shanghai Municipality, China, 200025