NCT04083079

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2019

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2019

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

August 26, 2019

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 10, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

September 10, 2019

Status Verified

September 1, 2019

Enrollment Period

2 years

First QC Date

August 26, 2019

Last Update Submit

September 5, 2019

Conditions

Lymphoma, Non-HodgkinGranulocyte Colony-Stimulating FactorCost-Benefit Analysis

Outcome Measures

Primary Outcomes (1)

  • Incremental Cost-Effectiveness ratio

    A comparison of the different strategies based on the incremental cost-effectiveness ratio (ICER), which is defined by the difference in costs between interventions, divided by the difference in their measured impact

    1 year

Secondary Outcomes (9)

  • Cost-Effectiveness ratio

    1 year

  • Sensitivity analysis

    1 year

  • Incidence of febrile neutropenia

    1 year

  • Duration time of febrile neutropenia

    1 year

  • Incidence of grade 3-4 neutropenia

    1 year

  • +4 more secondary outcomes

Study Arms (2)

PEG-rhG-CSF cohort

EXPERIMENTAL

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

Drug: PEG-rhG-CSF

rhG-CSF cohort

EXPERIMENTAL

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

Drug: rhG-CSF

Interventions

PEG-rhG-CSFDRUG

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

PEG-rhG-CSF cohort
rhG-CSFDRUG

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

rhG-CSF cohort

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin hospital

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

pegylated granulocyte colony-stimulating factor

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Central Study Contacts

Weili Zhao, PhD

CONTACT

+86 021 6437045zhao.weili@yahoo.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
First Deputy Director，Hematology Department

Study Record Dates

First Submitted

August 26, 2019

First Posted

September 10, 2019

Study Start

August 1, 2019

Primary Completion

August 1, 2021

Study Completion

April 1, 2022

Last Updated

September 10, 2019

Record last verified: 2019-09

Locations

CN(1)