Lapelga vs Gastrofil

NCT06116734 | Unknown Phase 3

• 1 other identifier: 1233770
• Study Type: interventional
• Target: 74
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Multiple Myeloma; Lymphoma; Engagement, Patient; Febrile Neutropenia

Outcome Measures

Primary Outcomes (1)

• Engraftment

  •Compare duration of neutropenia both in terms of absolute neutrophil count (ANC) \<0.5 · 109 /l and of days to reach an ANC \>0.5 · 109t between LaPelga versus gastrofil initiated at day 5 in patients with multiple myeloma or lymphoma post autologous transplant who meet the risk adapted criteria (age greater or equal to 60; prior episode of neutropenia and CD34 count of less than or equal to 3 X 10\^6/kg cells infused)

  11 days

Secondary Outcomes (1)

• AE

  30 days

Study Arms (2)

Biosimilar pegfilgrastim

EXPERIMENTAL

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

Drug: Lapelga

Biosimilar filgrastim

ACTIVE COMPARATOR

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

Drug: Grastofil®

Interventions

Grastofil® DRUG

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

Also known as: biosimilar filgrastim

Biosimilar filgrastim

Lapelga DRUG

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

Also known as: biosimilar pegfilgrastim

Biosimilar pegfilgrastim

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Apobiologix.: collaborator

MeSH Terms

Conditions

Multiple Myeloma; Lymphoma; Patient Participation; Febrile Neutropenia

Interventions

TKN732

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Lymphatic Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Neutropenia; Agranulocytosis; Leukopenia; Cytopenia; Leukocyte Disorders

Study Officials

• Shona Philip, MD

  London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shona Philip, MD

CONTACT

519-685-8500; Shona.Philip@lhsc.on.ca

Kate Kelly, MSc

CONTACT

519-685-8500; kate.kelly@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2023
• First Posted: November 3, 2023
• Study Start: November 1, 2023
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2025
• Last Updated: November 3, 2023

Record last verified: 2023-10