Lapelga vs Gastrofil

October 30, 2023 updated by: Lawson Health Research Institute

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

74

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Biosimilar pegfilgrastim
Day +5 of cell infusion: Biosimilar pegfilgrastim or Lapelga™ (one dose)
Drug: Lapelga
On day 5 after the hemopoietic stem cell transplant, one subcutaneous injection
Other Names:
  • biosimilar pegfilgrastim
Active Comparator: Biosimilar filgrastim
Day +5 of cell infusion: Biosimilar filgrastim or Grastofil® (one dose for 5 days)
Drug: Grastofil®
On day 5 after the hemopoietic stem cell transplant, one subcutaneous injection for 5 days
Other Names:
  • biosimilar filgrastim

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Engraftment
Time Frame: 11 days
•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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
AE
Time Frame: 30 days
  • Clinically significant infections (CTCAE v 5, Infections, grade 2 or higher)
  • Grade and duration of mucositis (CTCAE v 5, mucositis oral and diarrhea, any grade)
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lawson Health Research Institute

Collaborators

Apobiologix.

Investigators

  • Principal Investigator: Shona Philip, MD, Lawson Health Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2023

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

September 19, 2023

First Submitted That Met QC Criteria

October 30, 2023

First Posted (Actual)

November 3, 2023

Study Record Updates

Last Update Posted (Actual)

November 3, 2023

Last Update Submitted That Met QC Criteria

October 30, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1233770

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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