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Clinical Trial Details

Will priming intravenous administration sets with monoclonal antibodies reduce chair time in the outpatient setting? (The priming practice study)

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Trial Information

Broad Health Condition Cancer
Cancer
Cancer
Cancer
Cancer

Specific Health ConditionMyeloma
Leukaemia - Chronic leukaemia
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Lung - Non small cell
Malignant melanoma

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
QLD

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Trial summary

This study aims to investigate whether priming intravenous administration sets with monoclonal antibodies reduces chair time.

Who is it for?
You may be eligible for this study if you are an adult being treated with the single agent monoclonal antibodies: Obinutuzumab, Daratumumab, Nivolumab, Pembrolizumab at the Royal Brisbane and Women's Hospital.

Study details
Participants will randomly be allocated to one of two groups: one which has their IV line primed with the treatment drug, and one which is primed with diluent only before administration of the drug. Information on treatment duration, adverse reactions and patient experience will be collected on the day.

Information from this trial will inform the optimisation of patient flow and decreased hypersensitivity reactions in oncology care.
Eligibility

Key inclusion criteria

1.     Patients attending the Oncology Day Therapy Unit or Oncology Procedure Unit
2.	18 years or older
3.	Are being treated with the single agent monoclonal antibodies: Obinutuzumab, Daratumumab, Nivolumab, Pembrolizumab. 
4.	Any cycle of a patient’s treatment regime (e.g, 1st, 2nd, 3rd dose)

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

The exclusion criteria:
1.	Under 18 years of age
2.	Patients receiving treatment with a monoclonal antibody as an inpatient or at North Lakes
3.	Patients receiving any other monoclonal antibodies that do not meet the criteria of inclusion drugs, chemotherapy, supportive therapies or treatment as part of a pharmaceutical clinical trial
4.	No funding to approach patients who require a translator 
Contact details and further information

Sponsor Primary Sponsor Type: Hospital
Primary Sponsor Name: .Royal Brisbane and Women's Hospital
Primary Sponsor Address: .Royal Brisbane and Women's Hospital Butterfield Street, Herston QLD, 4029
Primary Sponsor Country: Australia

Trial IDACTRN12621000933853

Contact person for information and recruitmentDr
Nicole Gavin
Centre for Clinical Nursing Royal Brisbane and Women's Hospital Butterfield Street, Herston QLD, 4029
+61 7 36465833

Further information iconnicole.gavin@health.qld.gov.au
Australia