Overview

Lapelga vs Gastrofil

Status:
Not yet recruiting
Trial end date:
2025-11-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Lawson Health Research Institute
Collaborator:
Apobiologix.
Criteria
Inclusion Criteria:

- Patients must be able and willing to give written informed consent prior to any study
related procedures

- Patients with a diagnosis of multiple myeloma or lymphoma who are eligible for
autologous stem cell transplant

- All adult patients aged 18 to 75 years

- All patients admitted to LHSC for autologous peripheral blood stem cell transplant
receiving peripheral blood stem cell infusions at LHSC and post-transplant care at
either LHSC or WMH.

- Of the patients who are admitted for autologous stem cell transplant, the patients
that meet the risk adapted approach for GSCF will be included in the study. The risk
adapted criteria 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 providers
clinical discretion

- Conditioning chemotherapy as per usual clinical practice

Exclusion Criteria:Patients satisfying the above inclusion criteria but with the following
contraindications (prior to randomization) will be excluded from the study:

- Any clinical contraindications to filgrastim, e.g. hypersensitivity to G-CSF or E.
coli-derived proteins

- Pain requiring opioids with use of filgrastim during mobilization of autologous stem
cells.

- Unable or not willing to provide written consent