A Trial Looking at Ofatumumab for People With Chronic Lymphocytic Leukaemia Who Cannot Have More Intensive Treatment
NCT ID: NCT01678430
Last Updated: 2012-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
670 participants
INTERVENTIONAL
2011-12-31
2017-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Ofatumumab-Chlorambucil
Ofatumumab cycle 1: 300mg iv day 1, 1000mg iv day 8; cycle 2 onwards: 1000mg iv day 1 Chlorambucil: 10mg/m2 po days 1-7
Ofatumumab
Chlorambucil
Ofatumumab-Bendamustine
Ofatumumab cycle 1: 300mg iv day 1, 1000mg iv day 8; cycle 2 onwards: 1000mg iv day 1 Bendamustine: 70mg/m2 iv days 1 and 2
Ofatumumab
Bendamustine
Interventions
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Ofatumumab
Chlorambucil
Bendamustine
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Progressive marrow failure as manifested by the development of, or worsening of, anaemia and/or thrombocytopenia.
2. Massive (i.e. 6 cm below the left costal margin) or progressive or symptomatic splenomegaly.
3. Massive (i.e. 10 cm in longest diameter) or progressive or symptomatic lymphadenopathy.
4. Progressive lymphocytosis with an increase of more than 50% over a 2-month period or lymphocyte doubling time (LDT) of less than 6 months.
2. No prior cytotoxic or targeted therapy for CLL
3. Full-dose R-FC considered inappropriate for at least one of the following reasons
1. Age 75 or greater
2. WHO performance status 2 or 3
3. Cardiac impairment (NYHA class II)
4. Respiratory impairment (bronchiectasis or moderate COPD)
5. Renal impairment (estimated Glomerular Filtration Rate (eGFR) 10-30 ml/min)
6. Any other significant co-morbidity or factor that makes R-FC inappropriate
4. Considered able to tolerate Chl at the dose used in the LRF CLL4 trial (10mg/m2 d1-7)
5. Written informed consent
Exclusion Criteria
2. Uncontrolled auto-immune haemolytic anaemia or thrombocytopenia
3. Active infection
4. Seropositivity for HIV, HCV or HBV (surface antigen or and core antibody)
5. Severe renal impairment (eGFR less than 10ml/min)
6. Severe hepatic impairment (serum bilirubin more than twice the upper limit of normal) unless due to CLL or Gilbert's syndrome.
7. Concurrent treatment with glucocorticoids equivalent to more than prednisolone 20mg od
8. Prior treatment with monoclonal antibody therapy within the last 3 months.
9. Yellow fever vaccination within 4 weeks prior to treatment start
10. Known hypersensitivity to ofatumumab, bendamustine or chlorambucil or any of their excipients
11. CNS involvement with CLL
12. History of Richter transformation
13. Concomitant malignancies within the last 3 years except successfully treated non-melanoma skin cancer or carcinoma in situ.
14. Major surgery within 28 days prior to randomisation
15. WHO performance status 4
16. Severe cardiac disease including unstable angina, acute myocardial infarction within six months prior to randomization, congestive heart failure (NYHA III-IV), and arrhythmia (excluding extra systoles or minor conduction abnormalities) unless controlled by therapy.
17. Any serious underlying medical or psychological conditions, which could impair the ability of the patient to participate in the trial or compromise ability to give informed consent
18. Treatment within a clinical trial within 30 days prior to trial entry.
19. Adult patient under tutelage (not competent to sign informed consent).
20. Pregnant or lactating women.
21. Women of childbearing potential, including women whose last menstrual period was less than one year prior to screening, unable or unwilling to use adequate contraception from study start to one year after the last dose of protocol therapy. Adequate contraception is defined as hormonal birth control, intrauterine device, double barrier method or total abstinence.
22. Male subjects unable or unwilling to use adequate contraception methods from study start to one year after the last dose of protocol therapy.
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Napp Pharmaceuticals Limited
INDUSTRY
Chugai Pharma USA
INDUSTRY
University of Liverpool
OTHER
Locations
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Countess of Chester Hospital
Chester, Cheshire, United Kingdom
Derriford Hospital
Plymouth, Devon, United Kingdom
Torbay Hospital
Torquay, Devon, United Kingdom
Royal Bournemouth Hospital
Bournemouth, Dorset, United Kingdom
Dorset County Hospital
Dorchester, Dorset, United Kingdom
Colchester General Hospital
Colchester, Essex, United Kingdom
Basingstoke and North Hampshire Hospital
Basingstoke, Hampshire, United Kingdom
Southampton General Hospital
Southampton, Hampshire, United Kingdom
Barnet and Chase Farm Hospitals
Enfield, Hertfordshire, United Kingdom
Kent and Canterbury Hospital
Canterbury, Kent, United Kingdom
Maidstone Hospital
Maidstone, Kent, United Kingdom
Princess Royal Hospital
Orpington, Kent, United Kingdom
Queen Elizabeth Hospital
Woolwich, London, United Kingdom
West Middlesex University Hospital
Isleworth, Middlesex, United Kingdom
Ealing Hospital
Southall, Middlesex, United Kingdom
Hillingdon Hospital
Uxbridge, Middlesex, United Kingdom
Belfast City Hospital
Belfast, Northern Ireland, United Kingdom
Royal United Hospital
Bath, Somerset, United Kingdom
Weston General Hospital
Weston-super-Mare, Somerset, United Kingdom
Queens Hospital
Burton-on-Trent, Staffordshire, United Kingdom
Queen Elizabeth Hospital
Gateshead, Tyne and Wear, United Kingdom
Queen Elizabeth Hospital
Birmingham, West Midlands, United Kingdom
Bradford Royal Infirmary
Bradford, West Yorkshire, United Kingdom
Airdale General Hospital
Keighley, West Yorkshire, United Kingdom
St James University Hospital
Leeds, West Yorkshire, United Kingdom
Salisbury District Hospital
Salisbury, Wiltshire, United Kingdom
Arrowe Park Hospital
Upton, Wirral, United Kingdom
Royal Liverpool Hospital
Liverpool, , United Kingdom
Countries
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Central Contacts
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References
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Lim YJ, Duckworth AD, Clarke K, Kennedy P, Karpha I, Oates M, Gornall M, Kalakonda N, Slupsky JR, Pettitt AR. Influence of polyfunctional Tbet+ T cells on specific clinical events in chronic lymphocytic leukaemia. Front Immunol. 2025 Apr 17;16:1528405. doi: 10.3389/fimmu.2025.1528405. eCollection 2025.
Related Links
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Other Identifiers
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2011-000919-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
009988575
Identifier Type: REGISTRY
Identifier Source: secondary_id
OMB114578
Identifier Type: -
Identifier Source: org_study_id