Patient Preference for Pegfilgrastim (Neulasta®) Application Forms

NCT03619993 | Completed

• 1 other identifier: IOM-040369
• Study Type: interventional
• Target: 404
• Locations: 1 country
• Sites: 48

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.

Conditions

Non Hodgkin Lymphoma; Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Patient preference for type of pegfilgrastim application assessed via project specific survey answered after 4 applications.

  Percentage of patients favoring pegfilgrastim application via On-body injector. Patients are answering the questionnaire after 4 applications of pegfilgrastim in total, with On-body injector and pre-filled syringes used in alternating sequence (each type of application administered two times in total).

  4 cycles of chemotherapy, i.e. 8 to 12 weeks (depending on chemotherapeutic regimen)

Secondary Outcomes (6)

• Time point of pegfilgrastim application within a chemotherapy cycle

  4 cycles of chemotherapy, i.e. 8 to 12 weeks (depending on chemotherapeutic regimen)

• Patient preference for pegfilgrastim application assessed via project specific survey answered at time of enrollment

  at enrollment

• Impact of type of pegfilgrastim application on daily life of the patient assessed by direct questioning using project specific patient survey.

  4 cycles of chemotherapy, i.e. 8 to 12 weeks (depending on chemotherapeutic regimen)

• Percentage of nurses favoring pegfilgrastim application via On-body injector at study start and at end of study as stated via a project specific nurse survey

  from first enrollment to end of study of last patient at a site (= end of cycle 4 of last patient, expected to be latest 2.5 years after study start)

• Preference of investigators for either type of pegfilgrastim application at study start und at end of study assessed via project specific investigator survey

  from first enrollment to end of study of last patient at a site (= end of cycle 4 of last patient, expected to be latest 2.5 years after study start)

Other Outcomes (1)

• Resource utilization at site for either type of application assessed via project specific study nurse survey

  at end of study of last patient at a site (= end of cycle 4 of last patient, expected to be latest 2.5 years after study start)

Study Arms (2)

Arm A: Start with On-body injector

EXPERIMENTAL

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)

Device: On-body injector; Device: Pre-filled syringe

Arm B: Start with pre-filled syringe

EXPERIMENTAL

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)

Device: On-body injector; Device: Pre-filled syringe

Interventions

On-body injector DEVICE

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

Arm A: Start with On-body injector; Arm B: Start with pre-filled syringe

Pre-filled syringe DEVICE

For subcutaneous injection of a supportive medicine (Pegfilgrastim).

Arm A: Start with On-body injector; Arm B: Start with pre-filled syringe

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• iOMEDICO AG: lead
• Amgen: collaborator

Study Sites (48)

Research Site

Aschaffenburg, 63739, Germany

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Augsburg, 86150, Germany

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Berlin, 10367, Germany

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Bonn, 53111, Germany

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Celle, 29223, Germany

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Dresden, 01127, Germany

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Dresden, 01307, Germany

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Erfurt, 99084, Germany

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Flensburg, 24939, Germany

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Frankfurt (Oder), 15236, Germany

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Freiburg im Breisgau, 79110, Germany

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Georgsmarienhütte, 49124, Germany

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Goslar, 38642, Germany

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Göttingen, 37073, Germany

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Halberstadt, 38820, Germany

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Halle, 06110, Germany

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Hanover, 30161, Germany

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Heidelberg, 69120, Germany

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Herne, 44623, Germany

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Hildburghausen, 98646, Germany

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Hildesheim, 31134, Germany

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Kaiserslautern, 67655, Germany

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Kassel, 34119, Germany

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Köthen, 06366, Germany

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Krefeld, 47805, Germany

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Mannheim, 68165, Germany

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Mayen, 56727, Germany

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Moers, 47441, Germany

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Mühlhausen, 99974, Germany

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Mülheim, 45468, Germany

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München, 80639, Germany

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Naunhof, 04683, Germany

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Neunkirchen, 66538, Germany

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Neustadt in Sachsen, 01844, Germany

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Nordhorn, 48527, Germany

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Offenbach, 63069, Germany

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Oldenburg, 26121, Germany

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Ostfildern, 73760, Germany

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Passau, 94036, Germany

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Plauen, 08525, Germany

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Ratingen, 40878, Germany

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Rostock, 18107, Germany

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Singen, 78224, Germany

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Sömmerda, 99610, Germany

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Spremberg, 03130, Germany

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Stolberg, 52222, Germany

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Stralsund, 18435, Germany

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Würselen, 52146, Germany

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Related Publications (1)

• 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.

  PMID: 33956213 DERIVED

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Breast Neoplasms

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Michael Metz, Dr. med.

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2018
• First Posted: August 8, 2018
• Study Start: June 25, 2018
• Primary Completion: September 10, 2019
• Study Completion: September 10, 2019
• Last Updated: December 17, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (48)