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

NCT ID: NCT04083079

Last Updated: 2019-09-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-01
• Study Completion Date: 2022-04-01

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 for clinical decision-making.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

PEG-rhG-CSF cohort

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

Group Type: EXPERIMENTAL

PEG-rhG-CSF

Intervention Type: DRUG

Patients will be given PEG-rhG-CSF for primary/secondary prevention each cycle.

rhG-CSF cohort

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

Group Type: EXPERIMENTAL

rhG-CSF

Intervention Type: DRUG

Patients will be given rhG-CSF for either primary/secondary prevention or treatment once any neutropenia each cycle.

Interventions

PEG-rhG-CSF

Patients will be given PEG-rhG-CSF for primary/secondary prevention each cycle.

Intervention Type: DRUG

rhG-CSF

Patients will be given rhG-CSF for either primary/secondary prevention or treatment once any neutropenia each cycle.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhao Weili

First Deputy Director，Hematology Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ruijin hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Weili Zhao, PhD

Role: CONTACT

zhao.weili@yahoo.com

+86 021 6437045 ext. 610707

Facility Contacts

Pengpeng XU, MD, PhD

Role: primary

xpproc@msn.com

86-21-64370045 ext. 610707

Other Identifiers

PEG-rhG-CSF-01

Identifier Type: -

Identifier Source: org_study_id