Ongoing trials for MZL, including SMZL and NMZL patients
| Compound . | Clinical setting . | Class . | Target . | Ongoing trial . | ||||
|---|---|---|---|---|---|---|---|---|
| Phase . | N patients . | Comparator . | Primary endpoint . | Trial status . | ||||
| Obinutuzumab | Rituximab-refractory MZL (among iNHL) | mAb | CD20 | III (combo with bendamustine) | 414 | Bendamustine | PFS | NCT01059630; complete |
| r/r MZL (among B-cell NHL) | I/II (combo with lenalidomide) | 72 | MTD, DLT | NCT01995669; recruiting (est. completion May 2018) | ||||
| r/r MZL (among B-cell NHL) | I (combo with venetoclax and lenalidomide) | 60 | ORR | NCT02992522; recruiting (est. completion January 2020) | ||||
| Ibrutinib | r/r MZL | iTK | BTK, ITK | II | 60 | — | ORR | NCT01980628; complete |
| Relapsed MZL (among B-cell NHL) | I (combo with lenalidomide) | 34 | MTD | NCT01955499; active, not recruiting (est. analysis December 2019) | ||||
| First line; untreated MZL (together with follicular lymphoma) | I (combo with rituximab and lenalidomide) | 60 | PFS | NCT02532257; active, recruiting (est. completion April 2019 | ||||
| Lenalidomide | r/r MZL (together with follicular lymphoma) | II (combo with rituximab) | 357 | NCT01938001; active, not recruiting (est. completion December 2017 | ||||
| r/r MZL (together with follicular lymphoma) | III (combo with rituximab) | 500 | PFS | NCT01996865; active (est. completion March 2023) | ||||
| r/r MZL (among B-cell NHL) | I/II (combo with nivolumab) | 102 | MTD, ORR | NCT03015896; not yet recruiting (est. completion April 2020) | ||||
| r/r MZL (among NHL) | I (combo with blinatumomab) | 36 | MTD | NCT02568553; active (est. completion June 2018) | ||||
| Copanlisib | r/r MZL (among indolent NHL) | Small molecule | PI3K-δ and PI3K-α | III (combo with rituximab) | 514 | Rituximab + placebo | PFS [time frame: 59 mo] | NCT02367040; currently recruiting (est. completion March 2020) |
| First-line indolent NHL | III (combo with standard chemo) | 621 | Copanlisib/placebo + R-B or R-CHOP | PFS [time frame: 53 mo] | NCT02626455; currently recruiting (est. completion September 2021) | |||
| TGR-1202 | r/r MZL (among B-cell NHL) | Small molecule | PI3K-δ | II/III (combo with ublituximab +/−βendmaustine) | 500 | ORR | NCT02793583; active (est. completion July 2019) | |
| Venetoclax | r/r MZL (among B-cell NHL) | Small molecule | Bcl2 | I (combo with obinutuzumab, and lenalidomide | 60 | — | ORR | NCT02992522; currently recruiting (est. completion December 2019) |
| Pembrolizumab | r/r MZL (among B-cell NHL | I/Ib (combo with ibrutinib) | 58 | MTD | NCT02950220; currently recruiting (est. completion December 2019) | |||
| r/r MZL (among r/r iNHL or CLL) | mAB | Anti-PD-1 | II (combo with idelalisib or Ibrutinib) | 68 | — | ORR | NCT02332980; currently recruiting (est. completion January 2020) | |
| Compound . | Clinical setting . | Class . | Target . | Ongoing trial . | ||||
|---|---|---|---|---|---|---|---|---|
| Phase . | N patients . | Comparator . | Primary endpoint . | Trial status . | ||||
| Obinutuzumab | Rituximab-refractory MZL (among iNHL) | mAb | CD20 | III (combo with bendamustine) | 414 | Bendamustine | PFS | NCT01059630; complete |
| r/r MZL (among B-cell NHL) | I/II (combo with lenalidomide) | 72 | MTD, DLT | NCT01995669; recruiting (est. completion May 2018) | ||||
| r/r MZL (among B-cell NHL) | I (combo with venetoclax and lenalidomide) | 60 | ORR | NCT02992522; recruiting (est. completion January 2020) | ||||
| Ibrutinib | r/r MZL | iTK | BTK, ITK | II | 60 | — | ORR | NCT01980628; complete |
| Relapsed MZL (among B-cell NHL) | I (combo with lenalidomide) | 34 | MTD | NCT01955499; active, not recruiting (est. analysis December 2019) | ||||
| First line; untreated MZL (together with follicular lymphoma) | I (combo with rituximab and lenalidomide) | 60 | PFS | NCT02532257; active, recruiting (est. completion April 2019 | ||||
| Lenalidomide | r/r MZL (together with follicular lymphoma) | II (combo with rituximab) | 357 | NCT01938001; active, not recruiting (est. completion December 2017 | ||||
| r/r MZL (together with follicular lymphoma) | III (combo with rituximab) | 500 | PFS | NCT01996865; active (est. completion March 2023) | ||||
| r/r MZL (among B-cell NHL) | I/II (combo with nivolumab) | 102 | MTD, ORR | NCT03015896; not yet recruiting (est. completion April 2020) | ||||
| r/r MZL (among NHL) | I (combo with blinatumomab) | 36 | MTD | NCT02568553; active (est. completion June 2018) | ||||
| Copanlisib | r/r MZL (among indolent NHL) | Small molecule | PI3K-δ and PI3K-α | III (combo with rituximab) | 514 | Rituximab + placebo | PFS [time frame: 59 mo] | NCT02367040; currently recruiting (est. completion March 2020) |
| First-line indolent NHL | III (combo with standard chemo) | 621 | Copanlisib/placebo + R-B or R-CHOP | PFS [time frame: 53 mo] | NCT02626455; currently recruiting (est. completion September 2021) | |||
| TGR-1202 | r/r MZL (among B-cell NHL) | Small molecule | PI3K-δ | II/III (combo with ublituximab +/−βendmaustine) | 500 | ORR | NCT02793583; active (est. completion July 2019) | |
| Venetoclax | r/r MZL (among B-cell NHL) | Small molecule | Bcl2 | I (combo with obinutuzumab, and lenalidomide | 60 | — | ORR | NCT02992522; currently recruiting (est. completion December 2019) |
| Pembrolizumab | r/r MZL (among B-cell NHL | I/Ib (combo with ibrutinib) | 58 | MTD | NCT02950220; currently recruiting (est. completion December 2019) | |||
| r/r MZL (among r/r iNHL or CLL) | mAB | Anti-PD-1 | II (combo with idelalisib or Ibrutinib) | 68 | — | ORR | NCT02332980; currently recruiting (est. completion January 2020) | |
DLT, dose-limiting toxicity; est., estimated; iNHL, indolent non-Hodgkin lymphoma; MTD, maximal tolerated dose.