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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
Scientific title
Safety analysis of 90-minute Obinutuzumab infusion in Chronic Lymphocytic Leukaemia (CLL) and Follicular Lymphoma (FL) patients
Secondary ID [1] 312400 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Follicular lymphoma 334214 0
Chronic Lymphocytic Leukaemia 334215 0
Condition category
Condition code
Cancer 330879 330879 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 330880 330880 0 0
Leukaemia - Chronic leukaemia

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 328907 0
Treatment: Drugs
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)
Control group
Active

Outcomes
Primary outcome [1] 338632 0
Rates of infusion reactions
Timepoint [1] 338632 0
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.
Secondary outcome [1] 436737 0
Nurse acceptance
Timepoint [1] 436737 0
The nurses will only complete one survey at the end of their first intervention infusion rate.

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients that have had above grade 2 infusion reaction to obinutuzumab
Patients unable to give consent on their own will

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety
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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/11/2024
Actual
Date of last participant enrolment
Anticipated
17/11/2025
Actual
Date of last data collection
Anticipated
1/12/2025
Actual
Sample size
Target
128
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 26729 0
Cairns Hospital - Cairns
Recruitment postcode(s) [1] 42776 0
4870 - Cairns

Funding & Sponsors
Funding source category [1] 316808 0
Government body
Name [1] 316808 0
QLD health- Clinical research fellowship
Country [1] 316808 0
Australia
Primary sponsor type
Hospital
Name
Cairns Hospital
Address
Country
Australia
Secondary sponsor category [1] 319649 0
None
Name [1] 319649 0
Address [1] 319649 0
Country [1] 319649 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315579 0
Far North Queensland Human Research Ethics Committee
Ethics committee address [1] 315579 0
Ethics committee country [1] 315579 0
Australia
Date submitted for ethics approval [1] 315579 0
21/05/2024
Approval date [1] 315579 0
Ethics approval number [1] 315579 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135138 0
Mr Kristoffer Johnstone
Address 135138 0
Liz Plummer Cancer centre- Pharmacy department Cairns Hospital, Cnr of Lake and Groves street, North Cairns, 4870 QLD
Country 135138 0
Australia
Phone 135138 0
+61 0742266850
Fax 135138 0
Email 135138 0
kristoffer.johnstone@health.qld.gov.au
Contact person for public queries
Name 135139 0
Kristoffer Johnstone
Address 135139 0
Cairns Hospital pharmacy department Cairns Hospital, Cnr of Lake and Groves street, North Cairns, 4870 QLD
Country 135139 0
Australia
Phone 135139 0
+61 0742266850
Fax 135139 0
Email 135139 0
kristoffer.johnstone@health.qld.gov.au
Contact person for scientific queries
Name 135140 0
Kristoffer Johnstone
Address 135140 0
Cairns Hospital pharmacy department Cairns Hospital, Cnr of Lake and Groves street, North Cairns, QLD, 4870
Country 135140 0
Australia
Phone 135140 0
+61 0742266850
Fax 135140 0
Email 135140 0
kristoffer.johnstone@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
ProtocolNo Obinutuzuamab_Research Protocol V2 clean .docx
Supplementary materialsNo Obinutuzumab_V2_Patient_participant-info-sheet-consent_clean .docx
Supplementary materialsNo Obinutuzumab_V2__NURSE-info-sheet-consent.docx

Documents added automatically
No additional documents have been identified.