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Trial registered on ANZCTR
Registration number
ACTRN12624001142527p
Ethics application status
Submitted, not yet approved
Date submitted
25/06/2024
Date registered
20/09/2024
Date last updated
20/09/2024
Date data sharing statement initially provided
20/09/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
Safety analysis of 90-minute Obinutuzumab infusion
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Scientific title
Safety analysis of 90-minute Obinutuzumab infusion in Chronic Lymphocytic Leukaemia (CLL) and Follicular Lymphoma (FL) patients
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Secondary ID [1]
312400
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nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Follicular lymphoma
334214
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Chronic Lymphocytic Leukaemia
334215
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Condition category
Condition code
Cancer
330879
330879
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0
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Cancer
330880
330880
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0
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Leukaemia - Chronic leukaemia
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
CYCLE 1- DAY 1
FL: Day 1: 1000mg dose, commence at 50mg/hr, increment by 50mg/hr every 30 mins (max400mg/hr)
CLL: Day 1: 100mg dose at 25mg/hr followed by
Day 2: 900mg dose, commence at 50mg/hr, increment by 50mg/hr every 30 mins (max 400mg/hr
CYCLE 1- DAY 8
FL & CLL: 1000mg dose, commence at 100mg/hr, increment by 100mg/hr every 30mins (max 400mg/hr)
CYCLE 1- DAY 15
FL & CLL 1000mg dose, commence at 100mg/hr, increment by 100mg/hr every 30 mins (max 400mg/hr)
CYCLE 2 onwards
Standard infusion protocol -If patient experiences any grade 3 or 4 IRR during cycle 1 (or does not consent)
Commence at 100mg/hr, incrementing by 100mg/hr every 30 minutes (max 400mg/hr) (4-hour infusion time)
Rapid Infusion Protocol 90mins (intervention arm) from cycle 2 onwards
If maximum of grade 2 reaction during cycle 1
Fixed rate – 90 minutes (666mg/hr)
Treatment cycles vary in length according to chemotherapy backbone.
O-CHOP21, O-CVP = 21 day cycle with Obinutuzumab given on Day 1 of the cycle
O-acalabrutinb, O-Venetoclax, O-Chlorambucil, O-Bendamustine= 28 day cycle with Obinutuzumab given on Day 1 of the cycle
Obinutuzumab maintenance = 56 day cycle with Obinutuzumab given on Day 1 of the cycle
CLL patients will be treated for 6 cycles with Obinutuzumab
FL patients will be treated for 6 cycles then proceed onto maintenance for 2 years.
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Intervention code [1]
328907
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Treatment: Drugs
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Comparator / control treatment
Active control
CYCLE 2 onwards
Standard infusion protocol -If patient experiences any grade 3 or 4 IRR during cycle 1 (or does not consent)
Commence at 100mg/hr, incrementing by 100mg/hr every 30 minutes (max 400mg/hr) (4-hour infusion time)
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Control group
Active
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Outcomes
Primary outcome [1]
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Rates of infusion reactions
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Assessment method [1]
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Common Terminology Criteria for Adverse Events v3.0 (CTCAE) as classification for hypersensitivity reaction
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Timepoint [1]
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Every infusion on both the intervention arm and standard infusion arm will be assessed for adverse reactions, with special focus on Infusion related reactions for a period of 12 months or until number of infusions have been met to meet statistical significance.
Sample size and statistical power
Alpha value= 0.05
Beta value = 0.8
Variance = 20%
Sample size estimate would be 128 infusions.
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Secondary outcome [1]
436737
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Nurse acceptance
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Assessment method [1]
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Surveys
Nurses will complete an anonymous satisfaction survey after the completion of the first 90-minute infusion they administer. The survey is designed following the parameters of the diffusion of innovation theory. Key components that are assessed in the diffusion of innovation is the relative advantage, compatibility, complexity and trialability.
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Timepoint [1]
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The nurses will only complete one survey at the end of their first intervention infusion rate.
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Eligibility
Key inclusion criteria
All patients treated with Obinutuzumab for CLL or FL within Cairns Hospital
Must score 2 or below on the Eastern Cooperative Oncology Group (ECOG) assessment
Maximum of grade 2 or below previous infusion reaction
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Patients that have had above grade 2 infusion reaction to obinutuzumab
Patients unable to give consent on their own will
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
Safety
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Statistical methods / analysis
Logistic regression testing for Odds Ratio (OR) of reaction comparing the two cohorts of, retrospective and prospective obinutuzumab infusions. Patients previously treated in Cairns with Obinutuzumab will be compared to trial patients for rates of reactions. Other listed variables will be adjusted for confounding affect such as age, pre-treatment lymphocyte count, other chemotherapy or targeted therapy given in combination. Coefficients will be assigned to predictor variables, such cancer type and steroid dose for outcome variable.
Nursing surveys will be analysed with descriptive statistics of frequency and median level of acceptance and confidence in the administration process. T-Test and ANOVA will compare response rate between level of experience and level of acceptance to identify significant differences.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
4/11/2024
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Actual
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Date of last participant enrolment
Anticipated
17/11/2025
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Actual
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Date of last data collection
Anticipated
1/12/2025
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Actual
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Sample size
Target
128
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
26729
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Cairns Hospital - Cairns
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Recruitment postcode(s) [1]
42776
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4870 - Cairns
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Funding & Sponsors
Funding source category [1]
316808
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Government body
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Name [1]
316808
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QLD health- Clinical research fellowship
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Address [1]
316808
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Country [1]
316808
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Australia
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Primary sponsor type
Hospital
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Name
Cairns Hospital
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Address
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Country
Australia
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Secondary sponsor category [1]
319649
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None
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Name [1]
319649
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Address [1]
319649
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Country [1]
319649
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
315579
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Far North Queensland Human Research Ethics Committee
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Ethics committee address [1]
315579
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https://www.health.qld.gov.au/ohmr/html/regu/hrec_contacts.asp
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Ethics committee country [1]
315579
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Australia
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Date submitted for ethics approval [1]
315579
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21/05/2024
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Approval date [1]
315579
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Ethics approval number [1]
315579
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Summary
Brief summary
Study Overview This study aims to evaluate the safety of a 90-minute Obinutuzumab infusion in patients with Chronic Lymphocytic Leukemia (CLL) or Follicular Lymphoma (FL). Eligibility You may qualify for this study if you are 18 years or older, have Chronic Lymphocytic Leukaemia (CLL) or Follicular Lymphoma (FL) and are receiving treatment with Obinutuzumab at Cairns Hospital. Study Details After the first cycle, participants will receive a 90-minute Obinutuzumab infusion on Day 1 of each 21, 28, or 56-day cycle of treatment, continuing until disease progression or unacceptable adverse events occur. Alternatively, patients may choose to continue with the standard 6-hour infusion which is the current standard of care. As part of the study, patients will be closely monitored for infusion reactions will be assessed at each session. Benefits? This study hopes to improve patient's experience getting treatment with Obinutuzumab by reducing the time burden in chair to receive essential treatment.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Mr Kristoffer Johnstone
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Address
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Liz Plummer Cancer centre- Pharmacy department Cairns Hospital, Cnr of Lake and Groves street, North Cairns, 4870 QLD
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Country
135138
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Australia
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Phone
135138
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+61 0742266850
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Fax
135138
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Email
135138
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[email protected]
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Contact person for public queries
Name
135139
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Kristoffer Johnstone
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Address
135139
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Cairns Hospital pharmacy department Cairns Hospital, Cnr of Lake and Groves street, North Cairns, 4870 QLD
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Country
135139
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Australia
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Phone
135139
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+61 0742266850
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Fax
135139
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Email
135139
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[email protected]
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Contact person for scientific queries
Name
135140
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Kristoffer Johnstone
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Address
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Cairns Hospital pharmacy department Cairns Hospital, Cnr of Lake and Groves street, North Cairns, QLD, 4870
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Country
135140
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Australia
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Phone
135140
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+61 0742266850
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Fax
135140
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Email
135140
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
patient data is going to be collated into descriptive statistics and percentages with data not able to be identifiable.
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
Protocol
No
Obinutuzuamab_Research Protocol V2 clean .docx
Supplementary materials
No
Obinutuzumab_V2_Patient_participant-info-sheet-consent_clean .docx
Supplementary materials
No
Obinutuzumab_V2__NURSE-info-sheet-consent.docx
Documents added automatically
No additional documents have been identified.
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