Ongoing trials for MZL including NMZL patients
| Compound . | Clinical setting . | Class . | Target . | Ongoing trial . | ||||
|---|---|---|---|---|---|---|---|---|
| Phase . | No. of patients . | Comparator . | Primary end point . | Trial status . | ||||
| Obinutuzumab | Rituximab-refractory MZL (among iNHL) | mAb | CD20 | III (combo with bendamustine) | 414 | Bendamustine | PFS | Complete |
| Relapsed MZL (among iNHL) | I/II (combo with lenalidomide) | 72 | MTD, DLT | Recruiting (est. compl. 5/2016) | ||||
| Ibrutinib | r/r MZL (among iNHL) | iTK | BTK, ITK | III (combo with BR or rituximab only) | 400 | R-CHOP | PFS | Active (est. compl. 8/2012) |
| r/r MZL | II | 60 | ORR | Active, not recruiting (est. 12/2017) | ||||
| Relapsed MZL (among B-cell NHL) | I (combo with lenalidomide) | 34 | DLT, MTD, safety | 12/2015 (primary outcome measure) | ||||
| Lenalidomide | r/r MZL (among iNHL) | Small-molecule IMiDs | Immuno-modulatory | I (combo with rituximab and bendamustine) | 26 | MTD | Active, nonrecruiting (est. compl. 11/2016) | |
| r/r MZL (among B-cell NHL) | I/II (combo with romidepsin and rituximab) | 56 | MTD, ORR | Not yet recruiting (est. compl. 10/2020) | ||||
| r/r MZL (together with follicular lymphoma) | III (combo with rituximab) | 350 | Rituximab + placebo | PFS | 12/2016 | |||
| Ublituximab | r/r MZL (among B-cell NHL) | mAb | CD20 | I/II | 60 | MTD, safety | Complete | |
| Idelalisib | Rituximab and alkylating agents-refractory MZL (among iNHL) | Small molecule | PI3K | II | 125 (15 MZL) | ORR | Active, nonrecruiting (est. compl. 12/2015) | |
| r/r MZL (among iNHL) | III (combo with rituximab) | 375 | Rituximab + placebo | PFS | Recruiting (est. compl. 6/2022) | |||
| Idelalisib + GS-9973 | r/r hematologic malignancies | Small molecules | PI3K | II | 66 | ORR | Active, nonrecruiting (est. compl. 9/2015) | |
| Syk | ||||||||
| Duvelisib | Rituximab and CT or RIT-refractory MZL (among iNHL) | Small molecule | PI3K | II | 120 | ORR | Recruiting (est. compl. 1/2018) | |
| Compound . | Clinical setting . | Class . | Target . | Ongoing trial . | ||||
|---|---|---|---|---|---|---|---|---|
| Phase . | No. of patients . | Comparator . | Primary end point . | Trial status . | ||||
| Obinutuzumab | Rituximab-refractory MZL (among iNHL) | mAb | CD20 | III (combo with bendamustine) | 414 | Bendamustine | PFS | Complete |
| Relapsed MZL (among iNHL) | I/II (combo with lenalidomide) | 72 | MTD, DLT | Recruiting (est. compl. 5/2016) | ||||
| Ibrutinib | r/r MZL (among iNHL) | iTK | BTK, ITK | III (combo with BR or rituximab only) | 400 | R-CHOP | PFS | Active (est. compl. 8/2012) |
| r/r MZL | II | 60 | ORR | Active, not recruiting (est. 12/2017) | ||||
| Relapsed MZL (among B-cell NHL) | I (combo with lenalidomide) | 34 | DLT, MTD, safety | 12/2015 (primary outcome measure) | ||||
| Lenalidomide | r/r MZL (among iNHL) | Small-molecule IMiDs | Immuno-modulatory | I (combo with rituximab and bendamustine) | 26 | MTD | Active, nonrecruiting (est. compl. 11/2016) | |
| r/r MZL (among B-cell NHL) | I/II (combo with romidepsin and rituximab) | 56 | MTD, ORR | Not yet recruiting (est. compl. 10/2020) | ||||
| r/r MZL (together with follicular lymphoma) | III (combo with rituximab) | 350 | Rituximab + placebo | PFS | 12/2016 | |||
| Ublituximab | r/r MZL (among B-cell NHL) | mAb | CD20 | I/II | 60 | MTD, safety | Complete | |
| Idelalisib | Rituximab and alkylating agents-refractory MZL (among iNHL) | Small molecule | PI3K | II | 125 (15 MZL) | ORR | Active, nonrecruiting (est. compl. 12/2015) | |
| r/r MZL (among iNHL) | III (combo with rituximab) | 375 | Rituximab + placebo | PFS | Recruiting (est. compl. 6/2022) | |||
| Idelalisib + GS-9973 | r/r hematologic malignancies | Small molecules | PI3K | II | 66 | ORR | Active, nonrecruiting (est. compl. 9/2015) | |
| Syk | ||||||||
| Duvelisib | Rituximab and CT or RIT-refractory MZL (among iNHL) | Small molecule | PI3K | II | 120 | ORR | Recruiting (est. compl. 1/2018) | |
BR, bendamustine/rituximab; combo, combination; CT, chemotherapy; DLT, dose-limiting toxicity; est. compl., estimated completion; iNHL, indolent non-Hodgkin lymphoma; iTK, tyrosine-kinase inhibitor; ITK, inhibitor of tyrosine kinase; mAb, monoclonal antibody; MTD, maximum tolerated dose; NHL, non-Hodgkin lymphoma; r/r = relapsed/refractory; RIT, radioimmunotherapy.