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CLL12 asked whether starting the pill ibrutinib early, before chronic lymphocytic leukaemia causes symptoms, is better than the usual practice of watching and waiting; early treatment delayed the disease but after nearly six years of follow-up people lived just as long either way, so watch and wait remains the standard.
CLL12 was the German CLL Study Group's randomised, double-blind, placebo-controlled phase 3 trial that reassessed the watch-and-wait consensus in the era of targeted drugs. 363 patients with asymptomatic Binet stage A chronic lymphocytic leukaemia at increased risk of progression (by a validated score) were randomised to ibrutinib 420 mg daily or placebo; a further 152 low-risk patients were followed without treatment. The primary endpoint was event-free survival.
Ibrutinib significantly delayed progression to symptomatic disease, but at a median observation of 69.3 months overall survival was the same: five-year survival 93.3 percent with ibrutinib, 93.6 percent with placebo and 97.9 percent in the watch-and-wait cohort. Cardiovascular toxicity was more common with ibrutinib. The authors conclude that watch and wait remains the standard of care for early-stage disease whatever the risk profile, and that is how the corpus's chronic lymphocytic leukaemia page cites the trial.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
515 enrolled.
95% CI 89.3 to 97.3; median observation 69.3 months · 95% CI 89.5 to 97.7 · 95% CI 95.6 to 100
SourceReported for both treatment groups together; more cardiovascular toxicity with ibrutinib
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survival at 5 years | Ibrutinib 420 mg daily | 182 | 93.3% | - | - | link |
| Placebo | 181 | 93.6% | ||||
| Watch and wait (low-risk cohort, not randomised) | 152 | 97.9% | ||||
| Estimated overall survival at 10 years from diagnosis | Ibrutinib 420 mg daily | - | 89.8% | - | - | link |
| Placebo | - | 86.5% | ||||
| Watch and wait (low-risk cohort, not randomised) | - | 95.3% | ||||
| Serious adverse events | Ibrutinib 420 mg daily | - | 60% | - | - | link |
| Placebo | - | 60% |
Shares Ibrutinib, Johnson & Johnson, Small-molecule kinase inhibitors and the tag soc-trials.
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Shares Leukaemia (all types), Small-molecule kinase inhibitors and the tag soc-trials.
Shares Leukaemia (all types), Small-molecule kinase inhibitors and the tag soc-trials.
Shares Leukaemia (all types), Small-molecule kinase inhibitors and the tag soc-trials.
Shares Johnson & Johnson and the tag soc-trials.
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