Patient Preference Between a Prefilled Syringe or a Prefilled Pen Device for Administration of Pegfilgrastim (PELGRAZ)

Single-center, Randomized, Crossover Clinical Study to Assess Patient Preference Between the Use of a Prefilled Syringe or a Prefilled Pen Device for Pegfilgrastim Administration (PELGRAZ) as Primary Prophylaxis of Chemotherapy-related Neutropenia

Febrile neutropenia (NF) is a common serious complication of cancer chemotherapy. Outpatient management of chemotherapy treatments is made essential by the volume of patients treated, respect for their quality of life and the lack of hospitalization resources.

The prevention of NF is well documented and its success depends on the risks of developing NF related to the type of chemotherapy protocol used and the profile of the patient and his disease.

Pegfilgrastim (G-CSF, biosimilar medicine) injection has been shown to prevent (febrile) neutropenia. It is routinely prescribed on an outpatient basis for patients treated with chemotherapy (CT), several thousand times a year in our geographical area.

In order to take into account patient preferences and help clinical decision-making, this study will be conducted on the basis of self-administered questionnaires. The aim of the research is to assess patient preference for receiving administration of PELGRAZ (Accord Healthcare) using a prefilled syringe or a prefilled pen device. In a second step, this study will evaluate the learning of the patient and his autonomy during a pen self-injection guided by a nurse.

Study Overview

• Status: Active, not recruiting
• Conditions: Patient Satisfaction; Patient Preference; Febrile Neutropenia, Drug-Induced
• Intervention / Treatment: Device: PELGRAZ prefilled syringe or PELGRAZ prefilled pen

Detailed Description

Febrile neutropenia (NF) is a common serious complication of cancer chemotherapy. Outpatient management of chemotherapy treatments is made essential by the volume of patients treated, respect for their quality of life and the lack of hospitalization resources.

The prevention of NF is well documented and its success depends on the risks of developing NF related to the type of chemotherapy protocol used and the profile of the patient and his disease.

Pegfilgrastim (G-CSF, biosimilar medicine) injection has been shown to prevent (febrile) neutropenia. It is routinely prescribed on an outpatient basis for patients treated with chemotherapy (CT), several thousand times a year in our geographical area.

In order to take into account patient preferences and help clinical decision-making, this study will be conducted on the basis of self-administered questionnaires.

This research involves the administration/use of a product (PELGRAZ, Accord Healthcare) within its intended purpose. PELGRAZ prefilled syringe or prefilled pen are available on the European Union market.

The study will be carried out using a crossover design. Two modes of administration (syringe and pen) will be compared. Each subject will receive either the sequence syringe then pen, or pen then syringe.

The trial will be conducted among 150 cancer patients for whom a chemotherapy followed by the administration of pegfilgrastim is indicated.

The primary endpoint is a composite endpoint consisting of several parameters related to patient preference.

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

• Study Contact: Name: Paul IHOUT; Phone Number: + 33 (0)1 82 64 97 28; Email: paul.ihout@ccconcorde.org

Study Locations

• France
  • Ile-de-France
    • Levallois-Perret, Ile-de-France, France, 92300
      • Institut Rafael

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

150 patients for whom a chemotherapy treatment followed by PELGRAZ administration is indicated

Description

Inclusion Criteria:

• 18 years old and older
• Patients with solid tumors, Hodgkin's lymphoma, non-Hodgkin's lymphoma and receiving myelosuppressive chemotherapy with a risk of NF of 10-20% (individual risk factors), or ≥ 20% (primary prevention of neutropenia) and receiving PELGRAZ ® in accordance with CPR
• Prediction of the risk of NF without filgrastim or pegfilgrastim determined according to the recommendations of the EORTC
• ECOG ≤ 2
• Free and informed consent obtained
• Patient affiliated to a social security system or beneficiary of such a scheme

Exclusion Criteria:

• Pregnancy
• Breastfeeding
• Patients receiving concurrent radiotherapy
• Second cancer treated with chemotherapy
• Participation in any other clinical trial within 30 days prior to recruitment
• Concomitant myelosuppressive therapy, e.g. ex. immunosuppressive therapy
• History of severe hypersensitivity reaction to drugs intended for use and/or drugs derived from E. coli

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
A) administration starting with prefilled syringe; - Group A = Phase 1 then phases 2, 3, 4 The study protocol consists of 4 different stages; Phase 1: injection by pre-filled syringe by a state-certified nurse (IDE); Phase 2: pen injection guided (thanks to the detailed information) by the IDE; Phase 3: injection by pen in autonomy supervised by the IDE (can only interfere in case of non-compliance with the injection protocol) = Learning phase; Phase 4: injection by pen in complete autonomy, patient alone	Device: PELGRAZ prefilled syringe or PELGRAZ prefilled pen; PELGRAZ prefilled syringe or PELGRAZ prefilled pen https://www.ema.europa.eu/en/medicines/human/EPAR/pelgraz
B) administration starting with prefilled pen; - Group B = Phase 2, 3, 4 then phase 1 The study protocol consists of 4 different stages; Phase 1: injection by pre-filled syringe by a state-certified nurse (IDE); Phase 2: pen injection guided (thanks to the detailed information) by the IDE; Phase 3: injection by pen in autonomy supervised by the IDE (can only interfere in case of non-compliance with the injection protocol) = Learning phase; Phase 4: injection by pen in complete autonomy, patient alone	Device: PELGRAZ prefilled syringe or PELGRAZ prefilled pen; PELGRAZ prefilled syringe or PELGRAZ prefilled pen https://www.ema.europa.eu/en/medicines/human/EPAR/pelgraz

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
questionnaire	The primary endpoint is a composite endpoint consisting of several parameters related to patient preference	120 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
questionnaire, specific questions	patient learning and empowerment during self-injection; pain evaluation; duration of treatment;; patient satisfaction;; overview of the health, physical and psychological conditions of the patient according to his own perception;	120 days

Collaborators and Investigators

• Sponsor: Institut Rafael
• Investigators: Principal Investigator: Alain TOLEDANO, MD, Institut Rafael

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2023
• Primary Completion (Actual): September 9, 2023
• Study Completion (Estimated): October 9, 2024

Study Registration Dates

• First Submitted: June 9, 2023
• First Submitted That Met QC Criteria: June 9, 2023
• First Posted (Actual): June 18, 2023

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: patient preference; febrile neutropenia; survey; pegfilgrastim; questionnaires; chemotherapy prophylaxis
• Additional Relevant MeSH Terms: Hematologic Diseases; Agranulocytosis; Leukopenia; Leukocyte Disorders; Cytopenia; Neutropenia; Febrile Neutropenia; Chemotherapy-Induced Febrile Neutropenia
• Other Study ID Numbers: IR-2022/0011; ID RCB: 2022-A01465-38 (Other Identifier: ANSM France)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No