Patient Preference for Pegfilgrastim (Neulasta®) Application Forms

NCT ID: NCT03619993

Last Updated: 2019-12-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 404 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-25
• Study Completion Date: 2019-09-10

Brief Summary

The study aims to compare two application forms (pre-filled syringe and On-body injector) of the same active drug (pegfilgrastim) in adult patients under chemotherapy regarding patient preference and health economics. Chemotherapy will be supported with pegfilgrastim for four subsequent chemotherapy cycles using alternating application forms.

Detailed Description

Neutropenia is one of the most common side effects of myelosuppressive chemotherapy. Febrile neutropenia and infectious complications are associated with chemotherapy dose delays and reductions and an increased risk of hospitalization. Prophylaxis with recombinant G-CSFs reduces the incidence, severity and duration of CIN and the risk of developing FN. Pegfilgrastim is available for over 10 years and is specified in the SmPC to be applied at least 24 hours after cytotoxic chemotherapy. For this application patients often have to return to their physician one day after chemotherapy treatment for the sole purpose of receiving pegfilgrastim subcutaneous (s.c.) injection. For different reasons, some of the patients requiring pegfilgrastim may not be able to return at this day and thus may not receive pegfilgrastim in accordance with the SmPC. The On-body injector for pegfilgrastim provides an option for patients not to return to the clinic/medical office the day after chemotherapy for their pegfilgrastim injection. The kit includes a single-use prefilled syringe co-packed with the On-body injector for pegfilgrastim. The On-body injector is applied to the patient's skin at the day of chemotherapy treatment and it automatically delivers pegfilgrastim approximately 27 h after the On-body injector was applied to the patient's skin.

Patient-reported outcomes on preference for either application form can help to guide physicians' treatment choice, particularly in terms of application of the same active substance, in this study pegfilgrastim.

This study aims to compare the two application forms of pegfilgrastim (pegfilgrastim pre-filled syringe vs. On-body injector for pegfilgrastim) with regard to patient preference and health economy. A trial design with randomization of patients to receive the two application forms of pegfilgrastim in an alternating sequence for 4 cycles starting with either On-body injector for pegfilgrastim (Arm A) or pegfilgrastim pre-filled syringe (Arm B) was chosen. In this way, all patients will receive both application forms in order to be able to decide for their individual preference. Four cycles (that means each patient will receive each application form of pegfilgrastim twice) should be a sufficient number for the patient to make a decision. This design with two treatment arms serves to exclude a systematic bias that might be generated when starting with the same application form for all patients.

Conditions

Non Hodgkin Lymphoma; Breast Cancer

Keywords

R-CHOP; G-CSF; Early breast cancer; Anthracycline/cyclophosphamide; 1st line; immunochemotherapy; taxane

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Arm A: Start with On-body injector

4 consecutive cycles of treatment in total, with 2 cycles of treatment with pegfilgrastim pre-filled syringe (PS) and 2 cycles of treatment with On-body injector (OBI) for pegfilgrastim in an alternating sequence (OBI-PS-OBI-PS)

Group Type: EXPERIMENTAL

On-body injector

Intervention Type: DEVICE

Medical device for subcutaneous injection of a supportive medicine (Pegfilgrastim) automatically after 27 hours after application of device.

Pre-filled syringe

Intervention Type: DEVICE

For subcutaneous injection of a supportive medicine (Pegfilgrastim).

Arm B: Start with pre-filled syringe

4 consecutive cycles of treatment in total, with 2 cycles of treatment with pegfilgrastim pre-filled syringe (PS) and 2 cycles of treatment with On-body injector (OBI) for pegfilgrastim in an alternating sequence (PS-OBI-PS-OBI)

Group Type: EXPERIMENTAL

On-body injector

Intervention Type: DEVICE

Medical device for subcutaneous injection of a supportive medicine (Pegfilgrastim) automatically after 27 hours after application of device.

Pre-filled syringe

Intervention Type: DEVICE

For subcutaneous injection of a supportive medicine (Pegfilgrastim).

Interventions

On-body injector

Medical device for subcutaneous injection of a supportive medicine (Pegfilgrastim) automatically after 27 hours after application of device.

Intervention Type: DEVICE

Pre-filled syringe

For subcutaneous injection of a supportive medicine (Pegfilgrastim).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients with early breast cancer planned to receive 3 weekly or dose-dense anthracycline/cyclophosphamide combination or 3 weekly taxane containing chemotherapy regimen or patients with NHL planned to receive R-CHOP-14 or R-CHOP-21 immunochemotherapy as 1st-line treatment with the indication for G-CSF prophylaxis with pegfilgrastim for the prevention of FN and reduction in CIN duration. Patients have to be included before start of their (immuno-) chemotherapy.
• ECOG (Eastern Cooperative Oncology Group) performance status 0, 1 or 2
• Life expectancy > 3 months
• Absolute neutrophil count ≥ 1.5 x 109/L
• Ability to read and understand German
• Signed informed consent

Exclusion Criteria

• Hypersensitivity to the active substance or to any of the excipients
• Subject is currently enrolled or has not yet completed at least 30 days since ending other investigational device or drug trial(s) or is receiving investigational agent(s)
• Active infection or any serious underlying medical condition, which would impair the ability of the patient to receive protocol treatment
• Prior bone marrow or stem cell transplantion
• Subject of child-bearing potential is evidently pregnant (e.g. positive HCG (Human Chorionic Gonadotropin) test) or is breast feeding
• Subject is not using adequate contraceptive precautions.
• Other conditions which, in the opinion of the investigator, make participation in an investigational trial of this nature a poor risk
• Concerns for subject's compliance with the protocol procedures

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: collaborator

iOMEDICO AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Metz, Dr. med.

Role: STUDY_CHAIR

OSP Göttingen - Gemeinschaftspraxis Dres. Meyer, Ammon, Metz und Müller

Locations

Research Site

Aschaffenburg, , Germany

Research Site

Augsburg, , Germany

Research Site

Berlin, , Germany

Research Site

Bonn, , Germany

Research Site

Celle, , Germany

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Dresden, , Germany

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Dresden, , Germany

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Erfurt, , Germany

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Flensburg, , Germany

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Frankfurt (Oder), , Germany

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Freiburg im Breisgau, , Germany

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Georgsmarienhütte, , Germany

Research Site

Goslar, , Germany

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Göttingen, , Germany

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Halberstadt, , Germany

Research Site

Halle, , Germany

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Hanover, , Germany

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Heidelberg, , Germany

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Herne, , Germany

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Hildburghausen, , Germany

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Hildesheim, , Germany

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Kaiserslautern, , Germany

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Kassel, , Germany

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Köthen, , Germany

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Krefeld, , Germany

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Mannheim, , Germany

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Mayen, , Germany

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Moers, , Germany

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Mühlhausen, , Germany

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Mülheim, , Germany

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München, , Germany

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Naunhof, , Germany

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Neunkirchen, , Germany

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Neustadt in Sachsen, , Germany

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Nordhorn, , Germany

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Offenbach, , Germany

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Oldenburg, , Germany

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Ostfildern, , Germany

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Passau, , Germany

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Plauen, , Germany

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Ratingen, , Germany

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Rostock, , Germany

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Singen, , Germany

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Sömmerda, , Germany

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Spremberg, , Germany

Research Site

Stolberg, , Germany

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Stralsund, , Germany

Research Site

Würselen, , Germany

Countries

Germany

References

Metz M, Semsek D, Rogmans G, Hutzschenreuter U, Fietz T, Harde J, Zacharias S, Hielscher C, Lorenz A, Zahn MO, Guth D, Liebers S, Berghorn M, Grebhardt S, Matillon CD, Egerer G, Potthoff K. Patient, nurse, and physician preferences: final results of the CONVENIENCE study evaluating pegfilgrastim prophylaxis via pre-filled syringe or on-body injector in cancer patients. Support Care Cancer. 2021 Nov;29(11):6633-6643. doi: 10.1007/s00520-021-06230-9. Epub 2021 May 6.

Reference Type: DERIVED

PMID: 33956213 (View on PubMed)

Other Identifiers

IOM-040369

Identifier Type: -

Identifier Source: org_study_id