A Trial Looking at Ofatumumab for People With Chronic Lymphocytic Leukaemia Who Cannot Have More Intensive Treatment (RIAltO)
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|ClinicalTrials.gov Identifier: NCT01678430|
Recruitment Status : Unknown
Verified August 2012 by University of Liverpool.
Recruitment status was: Recruiting
First Posted : September 5, 2012
Last Update Posted : October 15, 2012
|Condition or disease||Intervention/treatment||Phase|
|Chronic Lymphocytic Leukaemia||Drug: Ofatumumab Drug: Chlorambucil Drug: Bendamustine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||670 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomised Investigation of Alternative Ofatumumab-containing Regimens in Less Fit Patients With CLL|
|Study Start Date :||December 2011|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2017|
Active Comparator: 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
Other Name: Arzerra
Other Name: Leukeran
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
Other Name: Arzerra
Other Name: Levact
- 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.
- Duration of response [ Time Frame: 6 years (after 2 years follow up of the last patient recruited) ]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.
- Overall survival [ Time Frame: 6 years (after 2 year follow up of the last patient recruited) ]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.
- Time to treatment failure [ Time Frame: 6 years (after 2 year follow up of the last patient recruited) ]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.
- Toxicity [ Time Frame: 6 years (after 2 years follow up of the last patient recruited) ]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.
- Treatment dose administered [ Time Frame: 5 years (assuming last patient in receives 12 cycles of treatment) ]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
- Quality of life [ Time Frame: 6 years (after 2 years follow up of the last patient recruited) ]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.
- Health Economic analysis [ Time Frame: 6 years (after 2 years follow up of the last patient recruited) ]
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.
- Analysis of frailty and co-morbidity [ Time Frame: Baseline, 2 months post treatment ]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.
- Predictive value of biomarkers [ Time Frame: Baseline, every 6 months until 42 months from study entry, disease progression ]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).
- Response [ Time Frame: Baseline; 2 months post treatment; 6 months post treatment ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01678430
|Contact: Kathryn Marley||+44 151 895 email@example.com|