A Trial Looking at Ofatumumab for People With Chronic Lymphocytic Leukaemia... | Recruiting
A Trial Looking at Ofatumumab for P... | Recruiting
A Trial Looking at Ofatumumab for People With Chronic Lymphocytic Leukaemia Who Cannot Have More Intensive Treatment
RIAltO

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Medical Conditions
  • Chronic Lymphocytic Leukaemia
Primary Contact Details
Recruitment Status
Recruiting
Trial source and source ID number
NCT01678430
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
The purpose of this study is to compare ofatumumab & chlorambucil (O-Chl) versus ofatumumab & bendamustine (O-B) in patients with Chronic Lymphocytic Leukaemia who are considered not fit enough for rituximab, fludarabine & cyclophosphamide (R-FC).
Research Details
  • Chlorambucil (Chl) has been the mainstay of CLL treatment for half a century. However, frontline treatment has improved considerably over the last decade, first by the advent of fludarabine plus cyclophosphamide (FC), and more recently by the addition of the anti-CD20 antibody, rituximab, to FC. Although FC-based regimens are considerably more effective than Chl, they are also associated with greater toxicity which makes them inappropriate for less fit patients. This is an important consideration, given that CLL predominantly affects older people who tend to have more co-morbidity. Although a single-arm phase II study (Roche MO20927; NCRI CLL208) has shown that R-Chl is safe and effective, there are no phase III data proving the benefit of adding an anti-CD20 antibody to Chl. This question is currently being addressed by a phase III RCT of Chl with or without ofatumumab (GSK OMB110911 / COMPLEMENT-1 / NCRI CLL7). Ofatumumab is a fully human anti-CD20 antibody that binds to an epitope distinct from that of rituximab and produces more complement-dependent cytotoxicity. The RIAltO trial is a direct follow-on to the NCRI CLL7 phase III RCT trial in less fit patients and therefore the Ofatumumab dose has been selected to mirror the regimen used in that trial.
Phase
Phase 3
Study Design
Sorry, this information is not available
Study Type
Interventional
Intervention
Drug : Ofatumumab, Drug : Chlorambucil, Drug : Bendamustine

Study Arm Groups : Ofatumumab-Chlorambucil, Ofatumumab-Bendamustine, Ofatumumab-Chlorambucil, Ofatumumab-Bendamustine

Intervention Type
See Interventions above
Primary Outcome Measures
    Progression-free survival; There are three pre-planned analyses of the PFS primary endpoint: end recruitment (approx 150 events); 300 events (after a minimum 12 months follow up for all patients), 400 events (after a minimum 24 months follow up for all patients)
Secondary Outcome Measures
    Duration of response; 6 years (after 2 years follow up of the last patient recruited); Overall survival; 6 years (after 2 year follow up of the last patient recruited); Time to treatment failure; 6 years (after 2 year follow up of the last patient recruited); Toxicity; 6 years (after 2 years follow up of the last patient recruited); Treatment dose administered; 5 years (assuming last patient in receives 12 cycles of treatment); Quality of life; 6 years (after 2 years follow up of the last patient recruited); Health Economic analysis; 6 years (after 2 years follow up of the last patient recruited); Analysis of frailty and co-morbidity; Baseline, 2 months post treatment; Predictive value of biomarkers; Baseline, every 6 months until 42 months from study entry, disease progression; Response; Baseline; 2 months post treatment; 6 months post treatment
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
All
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
670
Participant Inclusion Criteria
    Inclusion Criteria:

    1. CLL/SLL requiring treatment by NCI/IWCLL 2008 criteria. At least one of the following 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:

    1. Neutrophil count less than 1.0 x 109/l or platelet count less than 50 x 109/l unless due to CLL

    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.
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Local Institution
Plymouth
Devon
Belfast
Queen Elizabeth Hospital
Birmingham
Heart & Chest Hospital
Liverpool
Oldfield Surgery
Bath
Brook Lane Surgery
Southampton
Leeds
Bradford Royal Infirmary
Bradford
Torquay
North Hampshire & Basingstoke Hospital
Basingstoke
Royal Bournemouth
Bournemouth
Colchester General Hospital
Colchester
Queen Elizabeth Hospital, Gateshead
Gateshead
Maidstone Hospital and The Tunbridge Wells Hospital
Maidstone
Salisbury District Hospital
Salisbury
London
The Hillingdon Hospitals NHS FOUNDATION TRUST
Uxbridge
Countess of Chester Hospital
Chester
Cheshire
Dorset County Hospital
Dorchester
Dorset
Barnet and Chase Farm Hospitals
Enfield
Hertfordshire
Kent and Canterbury Hospital
Canterbury
Kent
Princess Royal Hospital
Orpington
Kent
West Middlesex University Hospital
Isleworth
Middlesex
Ealing Hospital
Southall
Middlesex
Weston General Hospital
Weston-super-Mare
Somerset
Queens Hospital
Burton upon Trent
Staffordshire
Airdale General Hospital
Keighley
West Yorkshire
Arrowe Park Hospital
Upton
Wirral
Trial Contact(s)
Primary Trial Contact
Kathryn Marley
+44 151 895 5287
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
A Randomised Investigation of Alternative Ofatumumab-containing Regimens in Less Fit Patients With CLL
EudraCT Number
Not available for this trial
Funder(s)
  • GlaxoSmithKline
  • Napp Pharmaceuticals Limited
  • Chugai Pharma USA
Other Study ID Numbers
OMB114578
Sponsor(s)
University of Liverpool
Key Dates

Recruitment Start Date

Dec 2011

Recruitment End Date

Dec 2017

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

30 Aug 2012

Date updated in source

12 Oct 2012