Selection of ongoing phase 3 trials in frontline treatment of CLL
| Study ID . | Experimental agent/s and comparator . | Trial design . | Patient number . | Clinical setting . | Current status . | Registration . |
|---|---|---|---|---|---|---|
| RIAltO | Bendamustine + ofatumumab vs chlorambucil + ofatumumab (comparator) | Multicenter, Open-label | 670 (planned) | Unfit for FCR | Recruiting | NCT01678430 |
| CLL12 | Ibrutinib vs placebo (comparator) | Multicenter, double-blinded | 360 (planned) | Early stage Binet stage A; high risk; fit and unfit | Recruiting | NCT02863718 |
| FLAIR | Ibrutinib + rituximab vs FCR (comparator) | Multicenter, Open-label | 754 (planned) | Fit | Recruiting | ISRCTN01844152 |
| ECOG1912 | Ibrutinib + rituximab vs FCR (comparator) | Multicenter, Open-label | 519 (planned) | Fit | Recruiting | NCT02048813 |
| ILLUMINATE | Ibrutinib + obinutuzumab vs chlorambucil + obinutuzumab (comparator) | Multicenter, Open-label | 212 | Elderly | Recruitment closed | NCT02264574 |
| A041202 | Ibrutinib + rituximab vs ibrutinib vs BR (comparator) | Multicenter, Open-label | 523 | Elderly | Recruitment closed | NCT01886872 |
| CLL14* | Obinutuzumab + venetoclax vs chlorambucil + obinutuzumab (comparator) | Multicenter, Open-label | 432 | Unfit | Recruitment closed | NCT02242942 |
| CLL13 | Obinutuzumab + ibrutinib + venetoclax vs obinutuzumab + venetoclax vs rituximab + venetoclax vs FCR/BR (comparator) | Multicenter, Open-label | 920 (planned) | Without del(17p)/TP53; Fit | Recruiting | NCT02950051 |
| UNITY-CLL | Ublituximab + TGR-1202 vs chlorambucil + obinutuzumab (comparator) | Multicenter, Open-label | 450 (planned; including RR) | Fit | Recruiting | NCT02612311 |
| Study ID . | Experimental agent/s and comparator . | Trial design . | Patient number . | Clinical setting . | Current status . | Registration . |
|---|---|---|---|---|---|---|
| RIAltO | Bendamustine + ofatumumab vs chlorambucil + ofatumumab (comparator) | Multicenter, Open-label | 670 (planned) | Unfit for FCR | Recruiting | NCT01678430 |
| CLL12 | Ibrutinib vs placebo (comparator) | Multicenter, double-blinded | 360 (planned) | Early stage Binet stage A; high risk; fit and unfit | Recruiting | NCT02863718 |
| FLAIR | Ibrutinib + rituximab vs FCR (comparator) | Multicenter, Open-label | 754 (planned) | Fit | Recruiting | ISRCTN01844152 |
| ECOG1912 | Ibrutinib + rituximab vs FCR (comparator) | Multicenter, Open-label | 519 (planned) | Fit | Recruiting | NCT02048813 |
| ILLUMINATE | Ibrutinib + obinutuzumab vs chlorambucil + obinutuzumab (comparator) | Multicenter, Open-label | 212 | Elderly | Recruitment closed | NCT02264574 |
| A041202 | Ibrutinib + rituximab vs ibrutinib vs BR (comparator) | Multicenter, Open-label | 523 | Elderly | Recruitment closed | NCT01886872 |
| CLL14* | Obinutuzumab + venetoclax vs chlorambucil + obinutuzumab (comparator) | Multicenter, Open-label | 432 | Unfit | Recruitment closed | NCT02242942 |
| CLL13 | Obinutuzumab + ibrutinib + venetoclax vs obinutuzumab + venetoclax vs rituximab + venetoclax vs FCR/BR (comparator) | Multicenter, Open-label | 920 (planned) | Without del(17p)/TP53; Fit | Recruiting | NCT02950051 |
| UNITY-CLL | Ublituximab + TGR-1202 vs chlorambucil + obinutuzumab (comparator) | Multicenter, Open-label | 450 (planned; including RR) | Fit | Recruiting | NCT02612311 |
Abbreviations explained in Tables 3 and 4.
Reference 32.