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

Sponsor

Institut Rafael (Other)

Overall Status

Recruiting

CT.gov ID

NCT05910164

Collaborator

(none)

150

Enrollment

Location

Anticipated Duration (Months)

9.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Patient Preference Febrile Neutropenia, Drug-Induced Patient Satisfaction	Device: PELGRAZ prefilled syringe or PELGRAZ prefilled pen

Detailed Description

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.

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 Design

Study Type:

Observational

Anticipated Enrollment :

150 participants

Observational Model:

Case-Crossover

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jun 9, 2023

Anticipated Primary Completion Date :

Jun 9, 2024

Anticipated Study Completion Date :

Oct 9, 2024

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

questionnaire [120 days]
The primary endpoint is a composite endpoint consisting of several parameters related to patient preference

Secondary Outcome Measures

questionnaire, specific questions [120 days]
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;

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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