Selection of completed phase 3 trials in frontline treatment of CLL
| Study ID . | Experimental agent/s and comparator . | Trial design . | Patient number . | Submission trial . | Median observation time, mo . | Median PFS, mo . | OS . | Reference . | Registration . | |
|---|---|---|---|---|---|---|---|---|---|---|
| Median, mo . | % vs % . | |||||||||
| CLL8 | FCR vs fludarabine + cyclophosphamide (comparator) | Multicenter, open-label | 817 | Yes; FDA and EMA approval | 70.8 | 56.8 vs 32.9 | NR vs 86.0 | 32, 35 | NCT00281918 | |
| CLL11 | Chlorambucil + obinutuzumab vs chlorambucil + rituximab vs chlorambucil (comparator) | Multicenter, open-label | 781 | Yes; FDA and EMA approval | 70.8 | 29.2 vs 15.4 vs 11.1 | OS after 2 y: 82 vs 84 vs 90 | 34 | NCT01010061 | |
| COMPLEMENT 1 | Chlorambucil + ofatumumab vs chlorambucil (comparator) | Multicenter, open-label | 447 | Yes; FDA and EMA approval | 28.9 | 22.4 vs 13.1 | OS after 2 y: 89 vs 87 | 36 | NCT00748189 | |
| CLL10 | BR vs FCR (comparator) | Multicenter, open-label | 561 | No | 37.1 | 41.7 vs 55.2 | OS after 3 y: 92 vs 91 | 39 | NCT00769522 | |
| MaBLe | BR vs chlorambucil + rituximab (comparator) | Multicenter, open-label | 241 | No | 24.0 | 39.6 vs 29.9 | 43.8 vs NR | 41 | NCT01056510 | |
| ORIGIN | Lenalidomide vs chlorambucil (comparator) | Multicenter, open-label | 450 | No | 18.8 | 30.8 vs 21.4 | NR vs 44.0 | 45 | NCT00910910 | |
| CLLM1 | Maintenance lenalidomide vs placebo (comparator) | Multicenter, double-blind | 89 | No | 17.9 | NR vs 13.3 | OS after 2 y: 97 vs 92 | 49 | NCT01556776 | |
| RESONATE-2 | Ibrutinib vs chlorambucil (comparator) | Multicenter, open-label | 269 | Yes; FDA and EMA approval | 18.4 | NR vs 18.9 | OS after 2 y: 98 vs 85 | 54 | NCT01722487 | |
| Study ID . | Experimental agent/s and comparator . | Trial design . | Patient number . | Submission trial . | Median observation time, mo . | Median PFS, mo . | OS . | Reference . | Registration . | |
|---|---|---|---|---|---|---|---|---|---|---|
| Median, mo . | % vs % . | |||||||||
| CLL8 | FCR vs fludarabine + cyclophosphamide (comparator) | Multicenter, open-label | 817 | Yes; FDA and EMA approval | 70.8 | 56.8 vs 32.9 | NR vs 86.0 | 32, 35 | NCT00281918 | |
| CLL11 | Chlorambucil + obinutuzumab vs chlorambucil + rituximab vs chlorambucil (comparator) | Multicenter, open-label | 781 | Yes; FDA and EMA approval | 70.8 | 29.2 vs 15.4 vs 11.1 | OS after 2 y: 82 vs 84 vs 90 | 34 | NCT01010061 | |
| COMPLEMENT 1 | Chlorambucil + ofatumumab vs chlorambucil (comparator) | Multicenter, open-label | 447 | Yes; FDA and EMA approval | 28.9 | 22.4 vs 13.1 | OS after 2 y: 89 vs 87 | 36 | NCT00748189 | |
| CLL10 | BR vs FCR (comparator) | Multicenter, open-label | 561 | No | 37.1 | 41.7 vs 55.2 | OS after 3 y: 92 vs 91 | 39 | NCT00769522 | |
| MaBLe | BR vs chlorambucil + rituximab (comparator) | Multicenter, open-label | 241 | No | 24.0 | 39.6 vs 29.9 | 43.8 vs NR | 41 | NCT01056510 | |
| ORIGIN | Lenalidomide vs chlorambucil (comparator) | Multicenter, open-label | 450 | No | 18.8 | 30.8 vs 21.4 | NR vs 44.0 | 45 | NCT00910910 | |
| CLLM1 | Maintenance lenalidomide vs placebo (comparator) | Multicenter, double-blind | 89 | No | 17.9 | NR vs 13.3 | OS after 2 y: 97 vs 92 | 49 | NCT01556776 | |
| RESONATE-2 | Ibrutinib vs chlorambucil (comparator) | Multicenter, open-label | 269 | Yes; FDA and EMA approval | 18.4 | NR vs 18.9 | OS after 2 y: 98 vs 85 | 54 | NCT01722487 | |
Completed registration trials for frontline therapy.
EMA, European Medicines Agency; FDA, US Food and Drug Administration; NR, not reached; OS, overall survival; PFS, progression-free survival; RR, relapse and refractory patients.