Clinical trial · Interventional
Patient Preference for Pegfilgrastim (Neulasta®) Application Forms
A Comparison of Pegfilgrastim (Neulasta®) Application Via Manual Injection Versus Injection Via an On-body Injector Regarding Patient Preference and Health Economics
NCT03619993CI-TRIAL-00042381CONVENIENCEcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Non Hodgkin Lymphoma | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| On-body injector | Device | — | UNRESOLVED |
| Pre-filled syringe | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A: Start with On-body injector
- description
- 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)
- interventionNames
- Device: On-body injector
- Device: Pre-filled syringe
- type
- EXPERIMENTAL
- label
- Arm B: Start with pre-filled syringe
- description
- 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)
- interventionNames
- Device: On-body injector
- Device: Pre-filled syringe
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDMetz 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