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

Shanghai Jiao Tong University

Status and phase: Unknown; Phase 4

Conditions: Cost-Benefit Analysis; Granulocyte Colony-Stimulating Factor; Lymphoma, Non-Hodgkin

Treatments: Drug: rhG-CSF; Drug: PEG-rhG-CSF

Study type: Interventional

Funder types: Other

Identifiers

NCT04083079

PEG-rhG-CSF-01

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 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 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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250 participants in 2 patient groups

PEG-rhG-CSF cohort

Experimental group

Description:

PEG-rhG-CSF primary/secondary prevention will be given 24-72 hours after each cycle for only once. Dosage: 6mg for weight ≥45kg，3mg for weight \<45kg, subcutaneous injection

Treatment:

Drug: PEG-rhG-CSF

rhG-CSF cohort

Experimental group

Description:

rhG-CSF primary/secondary prevention will be given 24-72 hours after each cycle until absolute neutrophil count ≥2×10\^9/L. rhG-CSF treatment will be given when there is neutropenia until absolute neutrophil count ≥2×10\^9/L. Dosage: 5μg/kg/d, subcutaneous injection

Treatment:

Drug: rhG-CSF