Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-27 @ 9:33 AM
Study NCT ID:
NCT06116734
Status:
UNKNOWN
Last Update Posted:
2023-11-03
First Post:
2023-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lapelga vs Gastrofil
Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Organization:
Study Overview
Official Title:
Open-label, Randomized Comparative Study to Assess Biosimilar Pegfilgrastim Versus Biosimilar Filgrastim in Patients With Multiple Myeloma and Lymphoma Post Autologous Hematopoietic Stem Cell Transplantation
Status:
UNKNOWN
Status Verified Date:
2023-10
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is examining one-time injection of biosimilar pegfilgrastim compared with multiple injection biosimilar filgrastim post autologous hematopoietic stem cell transplantation. Study aims to compare biosimilar pegfilgrastim - LaPelga and biosimilar filgrastim -Gastrofil to see if they are similar in efficacy in terms of neutrophil engraftment, limited adverse effects, and more convenience to our patients, with potential cost savings.
Detailed Description:
This will be a prospective open randomized controlled study. The study will be conducted in the inpatient setting at the London Health Sciences Centre (LHSC) in London, ON, and Windsor Metropolitan Hospital (WMH) in Windsor, ON. The objective of the study is to assess if biosimilar Peg-filgrastim similar is non-inferior to biosimilar filgrastim (LaPelga versus gastrofil) in terms of neutrophil engraftment in autologous transplant patients with lymphoma and multiple myeloma.
Current clinical practice uses a risk-adapted approach where we use originator filgrastim - Neupogen starting on day 5 for patients who are aged 60 or greater, infusion of stem cells with a CD34 count less than or equal 3 x 10\^6/kg, prior episodes of febrile neutropenia, or at the provider's clinical discretion. For the purposes of the trial, patients will be randomized to LaPelga versus gastrofil arm directly and will initiate assigned treatment at day+5 of autologous transplant.
Both LHSC and WMH have qualified investigators (hematologists or other qualified clinicians. The study will start only after receipt of regulatory and ethics approval. Screening investigations on patients will be done only after the signing of written informed consent.
Current clinical practice uses a risk-adapted approach where we use originator filgrastim - Neupogen starting on day 5 for patients who are aged 60 or greater, infusion of stem cells with a CD34 count less than or equal 3 x 10\^6/kg, prior episodes of febrile neutropenia, or at the provider's clinical discretion. For the purposes of the trial, patients will be randomized to LaPelga versus gastrofil arm directly and will initiate assigned treatment at day+5 of autologous transplant.
Both LHSC and WMH have qualified investigators (hematologists or other qualified clinicians. The study will start only after receipt of regulatory and ethics approval. Screening investigations on patients will be done only after the signing of written informed consent.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: