Lapelga vs Gastrofil

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 75 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06116734
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Lawson Health Research Institute
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Shona Philip, MD
Principal Investigator Affiliation	Lawson Health Research Institute
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Multiple Myeloma, Lymphoma, Engagement, Patient, Febrile Neutropenia

Additional Details

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.

Arms & Interventions

Arms

Experimental: Biosimilar pegfilgrastim

Day +5 of cell infusion: Biosimilar pegfilgrastim or Lapelga™ (one dose)

Active Comparator: Biosimilar filgrastim

Day +5 of cell infusion: Biosimilar filgrastim or Grastofil® (one dose for 5 days)

Interventions

Drug: - Grastofil®

On day 5 after the hemopoietic stem cell transplant, one subcutaneous injection for 5 days

Drug: - Lapelga

On day 5 after the hemopoietic stem cell transplant, one subcutaneous injection

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Shona Philip, MD

Shona.Philip@lhsc.on.ca

519-685-8500

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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