Home Administration of NivestimTM in the Primary Prophylaxis of Chemotherapy-Induced Febrile Neut… (NCT02956967) | Clinical Trial Compass
CompletedNot Applicable
Home Administration of NivestimTM in the Primary Prophylaxis of Chemotherapy-Induced Febrile Neutropenia
Germany171 participantsStarted 2015-09-23
Plain-language summary
Non-interventional, non-comparative, national, multi-site, single-arm prospective observational study to investigate home administration of Nivestim in the primary prophylaxis of chemotherapy-Induced febrile neutropenia
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male and female patients ≥ 18 years
* Declaration of informed consent signed by patient
* Patients with a solid tumour or with a malignant haematological tumour
* Patients who have been prescribed cytotoxic chemotherapy, irrespective of current cycle
* GCSF-naïve patients or patients pre-treated with GCSF who received no GCSF in the last three months before enrolment
* Patients starting primary prophylactic treatment using NivestimTM either to shorten the duration of a neutropenia or to prevent the occurrence of chemotherapy-induced FN
Exclusion Criteria:
* Patients with chronic myeloid leukaemia (CML) or with myelodysplastic syndrome (MDS)
* Patients who are hypersensitive to one of the excipients of NivestimTM
* Patients not undergoing chemotherapy
* Patients being treated curatively or as secondary prophylaxis with G-CSF
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of Participants With Any Significant Comorbidities
Timeframe: Baseline (Day 1)
2
Percentage of Participants With Different Types of Haematological Malignancies
Timeframe: Baseline (Day 1)
3
Percentage of Participants With Different Types of Solid Tumour
Timeframe: Baseline (Day 1)
4
Duration of Solid Tumour in Participants Prior to Enrolment in Study
Timeframe: Baseline (Day 1)
5
Number of Participants Who Received Chemotherapy Prior to Enrolment in Study
Timeframe: Baseline (Day 1)
6
Duration of Different Types of Chemotherapies Received by Participants During Study
Timeframe: Baseline up to 6 months
7
Percentage of Participants With Response to Study Treatment