Lapelga vs Gastrofil (NCT06116734) | Clinical Trial Compass
UnknownPhase 3
Lapelga vs Gastrofil
74 participantsStarted 2023-11-01
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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
What they're measuring
1
Engraftment
Timeframe: 11 days
Trial details
NCT IDNCT06116734
SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's