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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01110031
Registration number
NCT01110031
Ethics application status
Date submitted
22/04/2010
Date registered
23/04/2010
Date last updated
13/11/2017
Titles & IDs
Public title
Ofatumumab Cardiac Repolarization (QTc) Study in Fludarabine-Refractory Chronic Lymphocytic Leukemia Subjects
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Scientific title
An Open-Label, Single-Arm, Phase I Study to Evaluate the Effect of Ofatumumab on Cardiac Repolarization (QTc Duration) in Patients With Fludarabine-Refractory B-cell Chronic Lymphocytic Leukemia
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Secondary ID [1]
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112855
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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:
Leukaemia, Lymphocytic, Chronic
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Condition category
Condition code
Cancer
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Leukaemia - Acute leukaemia
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Cancer
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Leukaemia - Chronic leukaemia
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Cancer
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Children's - Leukaemia & Lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - Ofatumumab
Experimental: Treatment - Six months treatmet with ofatumumab will be given to subjects with chronic lymphocytic leukemia.
Treatment: Other: Ofatumumab
Anti-CD20 monoclonal antibody
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Intervention code [1]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Cardiac Repolarization (Fredericia's QTc)
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Assessment method [1]
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ECGs are collected in triplicate during the study to assess QTc effect.
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Timepoint [1]
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25-week ofatumumab treatment period
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Secondary outcome [1]
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Plasma concentrations of ofatumumab and electrocardiogram (ECG) parameters
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Assessment method [1]
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The pharmacokinetic results will be correlated to ECG findings to determine if drug concentrations relate to any ECG effects.
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Timepoint [1]
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25-week ofatumumab treatment period
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Secondary outcome [2]
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Vital signs, weight, adverse events
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Assessment method [2]
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Safety and tolerability of ofatumumab therapy will be determined by analysing changes in vital signs, weight, or development of adverse events.
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Timepoint [2]
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25-week ofatumumab treatment period plus 6-month follow-up after final ofatumumab infusion
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Secondary outcome [3]
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Flow cytometry
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Assessment method [3]
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Efficacy of ofatumumab therapy will be measured by the number of CD20 positive cells in the blood
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Timepoint [3]
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25-week ofatumumab treatment period plus 6-month follow-up after final ofatumumab infusion
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Secondary outcome [4]
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Cytokine, chemokine, human anti-human antibodies
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Assessment method [4]
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Effect of ofatumumab on circulating biomarkers in refractory Chronic Lymphocytic Leukemia (CLL) subjects will be determined by measuring changes in the cytokine, chemokine, human anti-human antibody levels.
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Timepoint [4]
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25-week ofatumumab treatment period plus 6-month follow-up after final ofatumumab infusion
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Eligibility
Key inclusion criteria
* Confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL).
* Active CLL disease and indication for treatment.
* Previous treatment with fludarabine-containing treatment that did not achieve at least a partial response or, disease progression occurred in responders within six months of the last dose of a fludarabine-containing treatment regimen.
* Fully active at a minimum, or fully capable of self-care and up and about more than 50% of waking hours.
* Age 18 years or older.
* Signed written informed consent.
* Acceptable levels of laboratory chemistry tests of potassium and magnesium.
* Males and female subjects must agree to use contraception (if fertile) from the time of the first dose of study medication until one year following last dose of ofatumumab.
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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
* Any abnormal electrocardiogram (ECG) or cardiac conduction findings .
* Certain heart problems, chronic infections, or serious significant diseases.
* Known transformation of CLL.
* CLL central nervous sytem involvement.
* Abnormal/inadequate blood values, liver, or kidney function.
* Past or current malignancy besides CLL, unless you have been free of malignancy for at least two years, have a history of completely resected non-melanoma skin cancer, or have been successfully treated.
* Lactating women or women with a positive pregnancy test.
* Use of medications known to prolong the heart rhythm.
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Study design
Purpose of the study
Other
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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
Single group
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
13/05/2010
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
26/06/2012
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Sample size
Target
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Accrual to date
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Final
12
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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GSK Investigational Site - Randwick
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Recruitment postcode(s) [1]
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2031 - Randwick
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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New Zealand
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State/province [2]
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Auckland
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Country [3]
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New Zealand
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State/province [3]
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Christchurch
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
GlaxoSmithKline
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
Ofatumumab is a fully-human monoclonal antibody that exhibits high binding affinity to an antigen on the surface of B lymphocytes. Antigen engagement by ofatumumab results in maximal B-cell killing through complement-dependent cytotoxicity and antigen-dependent cellular cytotoxicity in both antigen high- and low-expressing cells. Recent research has shown that ofatumumab-dependent B-cell depletion provides clinical benefit to subjects with CD20-positive cancers such as chronic lymphocytic leukemia (CLL). The purpose of the current study is to assess the impact of ofatumumab on electrocardiographic parameters with particular focus on cardiac repolarization (QTc interval duration) in subjects with refractory CLL. Subjects enrolled in this open-label, single-arm trial will receive ofatumumab at the highest clinical dose (2000 mg) studied or planned for study. Ofatumumab will be administered as eight weekly intravenous (IV) infusions followed by four monthly infusions, beginning in Week 13, across a 25-week treatment period. Cardiovascular effects will be evaluated during treatment through routine 12-lead electrocardiographic (ECG) monitoring. The pharmacokinetic relationship between plasma concentration of ofatumumab and its effect on QTc interval duration will be examined. Specifically, ECG assessments will be collected in triplicate at baseline, at the time of maximum ofatumumab concentrations periodically on-therapy, and at the end of treatment. After completion of the final ofatumumab infusion, subjects will continue to be followed for safety and efficacy for six months relative to the last ofatumumab dose.
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Trial website
https://clinicaltrials.gov/study/NCT01110031
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Trial related presentations / publications
Jewell RC, Laubscher K, Lewis E, Fang L, Gafoor Z, Carey J, McKeown A, West S, Wright O, Sedoti D, Dixon I, Hottenstein CS, Chan G. Assessment of the effect of ofatumumab on cardiac repolarization. J Clin Pharmacol. 2015 Jan;55(1):114-21. doi: 10.1002/jcph.376. Epub 2014 Aug 21.
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Public notes
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Contacts
Principal investigator
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GSK Clinical Trials
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Address
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GlaxoSmithKline
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT01110031
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