Chronic Lymphocytic LeukaemiaPhase 3RIAltONCT01678430
A Trial Looking at Ofatumumab for People With Chronic Lymphocytic Leukaemia Who Cannot Have More Intensive Treatment
A Phase 3 study testing Ofatumumab, Chlorambucil and Bendamustine in people with Chronic Lymphocytic Leukaemia, run by University of Liverpool at 28 sites in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukaemia
- What is being tested?
- Ofatumumab, Chlorambucil and Bendamustine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 670 participants
- Where
- 28 sitesUnited Kingdom
- Study dates
- Dec 2011to Dec 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CLL/SLL requiring treatment by NCI/IWCLL 2008 criteria. At least one of the following criteria:
- Progressive marrow failure as manifested by the development of, or worsening of, anaemia and/or thrombocytopenia.
- Massive (i.e. 6 cm below the left costal margin) or progressive or symptomatic splenomegaly.
- Massive (i.e. 10 cm in longest diameter) or progressive or symptomatic lymphadenopathy.
- Progressive lymphocytosis with an increase of more than 50% over a 2-month period or lymphocyte doubling time (LDT) of less than 6 months.
- No prior cytotoxic or targeted therapy for CLL
Show all 15Show fewer
- Full-dose R-FC considered inappropriate for at least one of the following reasons
- Age 75 or greater
- WHO performance status 2 or 3
- Cardiac impairment (NYHA class II)
- Respiratory impairment (bronchiectasis or moderate COPD)
- Renal impairment (estimated Glomerular Filtration Rate (eGFR) 10-30 ml/min)
- Any other significant co-morbidity or factor that makes R-FC inappropriate
- Considered able to tolerate Chl at the dose used in the LRF CLL4 trial (10mg/m2 d1-7)
- Written informed consent
Who cannot join
- Neutrophil count less than 1.0 x 109/l or platelet count less than 50 x 109/l unless due to CLL
- Uncontrolled auto-immune haemolytic anaemia or thrombocytopenia
- Active infection
- Seropositivity for HIV, HCV or HBV (surface antigen or and core antibody)
- Severe renal impairment (eGFR less than 10ml/min)
- Severe hepatic impairment (serum bilirubin more than twice the upper limit of normal) unless due to CLL or Gilbert's syndrome.
Show all 22Show fewer
- Concurrent treatment with glucocorticoids equivalent to more than prednisolone 20mg od
- Prior treatment with monoclonal antibody therapy within the last 3 months.
- Yellow fever vaccination within 4 weeks prior to treatment start
- Known hypersensitivity to ofatumumab, bendamustine or chlorambucil or any of their excipients
- CNS involvement with CLL
- History of Richter transformation
- Concomitant malignancies within the last 3 years except successfully treated non-melanoma skin cancer or carcinoma in situ.
- Major surgery within 28 days prior to randomisation
- WHO performance status 4
- 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.
- 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
- Treatment within a clinical trial within 30 days prior to trial entry.
- Adult patient under tutelage (not competent to sign informed consent).
- Pregnant or lactating women.
- 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.
- Male subjects unable or unwilling to use adequate contraception methods from study start to one year after the last dose of protocol therapy.
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
United Kingdom28 sites, 28 recruiting
- Recruiting
Basingstoke and North Hampshire Hospital
Basingstoke, Hampshire
Sylwia Simpson
- Recruiting
Royal United Hospital
Bath, Somerset
Christopher Knechtli
- Recruiting
Belfast City Hospital
Belfast, Northern Ireland
Paul Kettle
- Recruiting
Queen Elizabeth Hospital
Birmingham, West Midlands
Paul Moss
- Recruiting
Royal Bournemouth Hospital
Bournemouth, Dorset
Helen McCarthy
- Recruiting
Bradford Royal Infirmary
Bradford, West Yorkshire
Adrian Williams
- Recruiting
Queens Hospital
Burton-on-Trent, Staffordshire
Humayun Ahmad
- Recruiting
Kent and Canterbury Hospital
Canterbury, Kent
Christopher Pocock
- Recruiting
Countess of Chester Hospital
Chester, Cheshire
Salaheddin Tueger
- Recruiting
Colchester General Hospital
Colchester, Essex
Mike Hamblin
- Recruiting
Dorset County Hospital
Dorchester, Dorset
Akeel Moosa
- Recruiting
Barnet and Chase Farm Hospitals
Enfield, Hertfordshire
Andres Virchis
- Recruiting
Queen Elizabeth Hospital
Gateshead, Tyne and Wear
Scott Marshall
- Recruiting
West Middlesex University Hospital
Isleworth, Middlesex
Magda Alobaidi
- Recruiting
Airdale General Hospital
Keighley, West Yorkshire
Chetan Patalappa
- Recruiting
St James University Hospital
Leeds, West Yorkshire
Peter Hillmen
- Recruiting
Royal Liverpool Hospital
Liverpool
Andrew Pettitt
- Recruiting
Maidstone Hospital
Maidstone, Kent
Saad Rassam
- Recruiting
Princess Royal Hospital
Orpington, Kent
Corrine De Lord
- Recruiting
Derriford Hospital
Plymouth, Devon
Simon Rule
- Recruiting
Salisbury District Hospital
Salisbury, Wiltshire
Jonathan Cullis
- Recruiting
Ealing Hospital
Southall, Middlesex
Richard Kaczmarski
- Recruiting
Southampton General Hospital
Southampton, Hampshire
Andrew Duncombe
- Recruiting
Torbay Hospital
Torquay, Devon
Deborah Turner
- Recruiting
Arrowe Park Hospital
Upton, Wirral
Ranjit Dasgupta
- Recruiting
Hillingdon Hospital
Uxbridge, Middlesex
Richard Kaczmarski
- Recruiting
Weston General Hospital
Weston-super-Mare, Somerset
Philip Robson
- Recruiting
Queen Elizabeth Hospital
Woolwich, London
Corrine De Lord
About this study
Official title: A Randomised Investigation of Alternative Ofatumumab-containing Regimens in Less Fit Patients With CLL
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).
Read the detailed description
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.
- Conditions
- Chronic Lymphocytic Leukaemia
- Being tested
- Ofatumumab, Chlorambucil, Bendamustine
- Keywords
- Chronic Lymphocytic Leukaemia, Less fit, CD20 antibody, Ofatumumab, Chlorambucil, Bendamustine
- Medical subject headings
- Leukemia, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OfatumumabDrug
Also called Arzerra
ChlorambucilDrug
Also called Leukeran
BendamustineDrug
Also called Levact
| Study group | Role | What they receive |
|---|---|---|
| Ofatumumab-Chlorambucil | Active comparator | 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 Receives: Drug: Ofatumumab; Drug: Chlorambucil |
| Ofatumumab-Bendamustine | Experimental | 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 Receives: Drug: Ofatumumab; Drug: Bendamustine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Calculated from the date of randomisation to the date of progression or death, or the censor date.
Measured: 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 outcomes (10)
Duration of response
Response duration is defined as the time from when the criteria for partial or complete response are met until the first documentation of relapse or progression.
Measured: 6 years (after 2 years follow up of the last patient recruited)
Overall survival
Overall survival is defined as the time from initiation of study treatment to death, irrespective of cause or subsequent treatment. Patients still alive at the time of analysis will be censored at the date last seen alive at last follow up.
Measured: 6 years (after 2 year follow up of the last patient recruited)
Time to treatment failure
Time to treatment failure is defined as the time from initiation of study treatment to death, disease progression, or initiation of alternative treatment due to failure to achieve a complete or partial response to the study treatment.
Measured: 6 years (after 2 year follow up of the last patient recruited)
Toxicity
Haematological toxicity will be reported in accordance with the 2008 NCI/IWCLL guidelines. Non-haematological toxicity will be reported in accordance with the current Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
Measured: 6 years (after 2 years follow up of the last patient recruited)
Treatment dose administered
The number of cycles of treatment and cumulative dose of individual drugs administered will be summarised for each treatment group separately and compared across treatment groups
Measured: 5 years (assuming last patient in receives 12 cycles of treatment)
Quality of life
Quality of life will be assessed using the EQ-5D; EQ-VAS; EORTC QLQ-C30 and EORTC QLQ-CLL16 questionnaires. To standardise the raw scores, they will be linearly transformed into 0-to-100 scores.
Measured: 6 years (after 2 years follow up of the last patient recruited)
Health Economic analysis
The economic evaluation will take the form of a cost-effectiveness analysis with the differential cost of the alternative treatments will be related to their differential benefits in terms of quality-adjusted life years (QALYs). Incremental cost-utility ratios will be estimated based on QALY estimates.
A range of uni- and multi-variate, as well as probabilistic sensitivity analyses will be conducted to assess the robustness of the analysis.
The use of bootstrapping and cost-effectiveness acceptability curves will facilitate a measure of variability around cost-effectiveness estimates. Sensitivity analysis will be used to consider the importance of sources of uncertainty other than sample variation (e.g. unit costs, discount rates).
A model-based extrapolation of the trial results will be performed to explore the impact of a longer analytic time horizon, and consideration of health outcomes on the treatment cost-effectiveness.
Measured: 6 years (after 2 years follow up of the last patient recruited)
Analysis of frailty and co-morbidity
Patients outcomes will be compared across patient subgroups defined by CIRS, performance status, Vulnerable Elders Survey-13, Groningen Frailty Index (GFI) questionnaires and the Timed 'Up and Go' test.
Measured: Baseline, 2 months post treatment
Predictive value of biomarkers
Patient outcomes will be compared across patient subgroups defined by clinical (e.g. age, sex, stage) and laboratory (e.g. chromosomal, abnormalities, IGHV mutation status, TP53 mutation status).
Measured: Baseline, every 6 months until 42 months from study entry, disease progression
Response
Response following initial therapy will be assessed in accordance with the revised (2008) NCI/IWCLL response criteria applicable to CLL. Minimal residual disease will be assessed by multicolour flow cytometric analysis of bone marrow aspirate samples taken 2 months after completing treatment and of blood samples taken 2 and 6 months after completing treatment.
Measured: Baseline; 2 months post treatment; 6 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2012 (estimated)
- Study startDec 2011
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Lymphocytic LeukaemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 670 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Liverpool
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline, Napp Pharmaceuticals Limited, Chugai Pharma USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01678430
- Sponsor's protocol ID
- OMB114578
- Other IDs
- 2011-000919-22, 009988575
- Acronym
- RIAltO
- Status last verified
- Aug 2012
- First submitted
- 30 Aug 2012
- Last updated
- 15 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 40313965
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Investigation of Alternative Ofatumumab-containing Regimens in Less Fit Patients With CLL
- ClinicalTrials.gov ID
- NCT01678430
- Acronym / sponsor ID
- RIAltO / OMB114578
- Conditions
- Chronic Lymphocytic Leukaemia
- Keywords
- Chronic Lymphocytic Leukaemia, Less fit, CD20 antibody, Ofatumumab, Chlorambucil, Bendamustine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 670 participants (estimated)
- Lead sponsor
- University of LiverpoolUniversity, hospital or other
- Collaborators
- GlaxoSmithKline, Napp Pharmaceuticals Limited, Chugai Pharma USA
- Study start
- Dec 2011
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 5 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ofatumumab-Chlorambucil | Active comparator | Drug: Ofatumumab, Drug: ChlorambucilOfatumumab 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-Bendamustine | Experimental | Drug: Ofatumumab, Drug: BendamustineOfatumumab 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- CLL/SLL requiring treatment by NCI/IWCLL 2008 criteria. At least one of the following criteria:
- No prior cytotoxic or targeted therapy for CLL
- Full-dose R-FC considered inappropriate for at least one of the following reasons
- Considered able to tolerate Chl at the dose used in the LRF CLL4 trial (10mg/m2 d1-7)
- Written informed consent
Key exclusion criteria (22 listed)
- Neutrophil count less than 1.0 x 109/l or platelet count less than 50 x 109/l unless due to CLL
- Uncontrolled auto-immune haemolytic anaemia or thrombocytopenia
- Active infection
- Seropositivity for HIV, HCV or HBV (surface antigen or and core antibody)
- Severe renal impairment (eGFR less than 10ml/min)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OfatumumabAlso: Arzerra | Drug | Ofatumumab-Bendamustine, Ofatumumab-Chlorambucil |
| ChlorambucilAlso: Leukeran | Drug | Ofatumumab-Chlorambucil |
| BendamustineAlso: Levact | Drug | Ofatumumab-Bendamustine |
Primary outcome
Progression-free survival
Time frame: 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)
Calculated from the date of randomisation to the date of progression or death, or the censor date.
10 secondary outcomes
Duration of response
Time frame: 6 years (after 2 years follow up of the last patient recruited)
Overall survival
Time frame: 6 years (after 2 year follow up of the last patient recruited)
Time to treatment failure
Time frame: 6 years (after 2 year follow up of the last patient recruited)
Toxicity
Time frame: 6 years (after 2 years follow up of the last patient recruited)
Treatment dose administered
Time frame: 5 years (assuming last patient in receives 12 cycles of treatment)
Quality of life
Time frame: 6 years (after 2 years follow up of the last patient recruited)
Health Economic analysis
Time frame: 6 years (after 2 years follow up of the last patient recruited)
Analysis of frailty and co-morbidity
Time frame: Baseline, 2 months post treatment
Predictive value of biomarkers
Time frame: Baseline, every 6 months until 42 months from study entry, disease progression
Response
Time frame: Baseline; 2 months post treatment; 6 months post treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2012.
- Derived from this study: PubMed 40313965Lim 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ofatumumab, Chlorambucil and Bendamustine in people with Chronic Lymphocytic Leukaemia, run by University of Liverpool at 28 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kathryn Marley (+44 151 895 5287, kathryn.marley@liv.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01678430, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2012.