Efficacy of Biosimilar Filgrastim on the Mobilization of Hematopoietic Stem Cell CD34+ (Cluster of Differentiation 34) and on the Kinetic Engraftment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The endogenous growth factor granulocyte (G-CSF) stimulates the proliferation and differentiation of hematopoietic progenitors commissioned to mature as neutrophils and activated granulocytes mature neutrophils. In the field of hematology oncology G-CSF it is used to reduce the duration and complications of chemotherapy-induced neutropenia and to stimulate the mobilization and subsequent collection of circulating hematopoietic stem cells in order to use them for autologous transplantation procedure.

Filgrastim and Lenograstim originator are marketed for many years and are considered the reference molecules for the production of biosimilar.

For several years it is available and entered into common clinical practice the use of filgrastim biosimilar (Bio-GCSF) in treating the patient oncohematologic.

Aim of the study is to analyze retrospectively a large series of patients and assess the impacts of the Bio-GCSF on the collection of hematopoietic stem cells and recovery of blood counts post autologous transplantation; the data will be compared with a historical cohort of reference that has been treated with G-CSF originator.

The study results will not generate any diagnostic or therapeutic intervention in patients still alive.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of Pharmacokinetic and Pharmacodynamic Parameters of Filgrastim (G-CSF)Produced by Blausiegel Indústria e Comércio Ltda. Compared to Granulokine Produced by Produtos Roche Químicos e Farmacêuticos S/A.

NCT01549301

Healthy Subjects

COMPLETED PHASE1

Descriptive Analysis of G-CSF Use in Patients With Breast Cancer, Lung Cancer, or Lymphoma Treated

NCT02921191

Breast Cancer Lung Cancer

COMPLETED

Comparative Effectiveness Analysis of Granulocyte Colony Stimulating Factor Originator Products Versus Biosimilars

NCT04971304

Cancer, Breast Cancer, Lung Cancer of Colon +3 more

COMPLETED

A Study in Healthy Volunteers to Assess Immune Response to Multiple Injections of Filgrastim Hospira or Neupogen Reference Product.

NCT02923791

Healthy Volunteers

COMPLETED PHASE1

Evaluation of Dose-response, Pharmacodynamic and Pharmacokinetic Bioequivalence of Filgrastim in Healthy Male Volunteers After Single and Multiple-dose Subcutaneous Administration of the Test Injectable Formulation BK0023 vs. Neupogen®

NCT01933971

Healthy Male Subjects

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Blood Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

FILGRASTIM

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* \> 18 years with history of autologous transplant
* hematological diseases including:
* Multiple Myeloma
* Hodgkin's Lymphoma
* Non-Hodgkin lymphoma B and T
* Lymphocytic leukemia
* Acute myeloid leukemia