Ongoing first-line studies under evaluation in MCL
| Patient status/trial name . | Phase . | N . | Treatment . | First outcome . | ClinicalTrials.gov . |
|---|---|---|---|---|---|
| Transplant eligible | |||||
| TRIANGLE | 3 | 870 | R-CHOP/R-DHAP → ASCT | EFS | NCT02858258 |
| R-CHOP + ibrutinib/R-DHAP → ASCT + ibrutinib maintenance | |||||
| R-CHOP + ibrutinib/R-DHAP → ibrutinib maintenance | |||||
| EA4151 | 3 | 689 | Rituximab chemotherapy → MRD | OS | NCT03267433 |
| MRD positive: ASCT + rituximab maintenance | |||||
| MRD negative: ASCT + rituximab maintenance vs rituximab maintenance | |||||
| Transplant ineligible | |||||
| E1411 | 2 | 332 | Bendamustine-rituximab → rituximab maintenance | PFS | NCT01415752 |
| Bendamustine-rituximab → rituximab-lenalidomide maintenance | |||||
| Bendamustine, rituximab, and bortezomib (Velcade) → rituximab maintenance | |||||
| Bendamustine, rituximab, and bortezomib (Velcade) → rituximab-lenalidomide maintenance | |||||
| SHINE | 3 | 523* | Bendamustine-rituximab → rituximab maintenance | PFS | NCT01776840 |
| Bendamustine-rituximab-ibrutinib → rituximab-ibrutinib maintenance | |||||
| ACE-LY-308 | 3 | 546† | Bendamustine-rituximab → rituximab maintenance | PFA | NCT02972840 |
| Bendamustine-rituximab-acalabrutinib → rituximab-acalabrutinib maintenance | |||||
| MCL-R2 Elderly | 3 | 633 | First: R-CHOP vs R-CHOP/R-HAD; second: rituximab maintenance vs rituximab-lenalidomide maintenance | PFS | NCT01865110 |
| ENRICH | 2/3 | 400 | Rituximab chemotherapy with maintenance rituximab vs ibrutinib-rituximab with maintenance rituximab | PFS | N/A |
| Chemotherapy free | |||||
| WINDOW I | 2 | 131 | Part 1: chemotherapy-free ibrutinib-rituximab treatment | ORR | NCT02427620 |
| WINDOW II | 2 | 50 | Group 3: chemotherapy-free venetoclax-ibrutinib-rituximab treatment | CR | NCT03710772 |
| ENRICH | 2/3 | 400 | Chemotherapy-free arm with ibrutinib-rituximab and a rituximab maintenance arm | PFS | N/A |
| ALR | 2 | 24 | Induction: acalabrutinib-lenalidomide-rituximab cycles 1-12; maintenance: cycles 13-POD | MRD-negative CR | NCT03863184 |
| VLR | 1 | 28 | Venetoclax-lenalidomide-rituximab cycles 1-12 | MTD | NCT03523975 |
| Patient status/trial name . | Phase . | N . | Treatment . | First outcome . | ClinicalTrials.gov . |
|---|---|---|---|---|---|
| Transplant eligible | |||||
| TRIANGLE | 3 | 870 | R-CHOP/R-DHAP → ASCT | EFS | NCT02858258 |
| R-CHOP + ibrutinib/R-DHAP → ASCT + ibrutinib maintenance | |||||
| R-CHOP + ibrutinib/R-DHAP → ibrutinib maintenance | |||||
| EA4151 | 3 | 689 | Rituximab chemotherapy → MRD | OS | NCT03267433 |
| MRD positive: ASCT + rituximab maintenance | |||||
| MRD negative: ASCT + rituximab maintenance vs rituximab maintenance | |||||
| Transplant ineligible | |||||
| E1411 | 2 | 332 | Bendamustine-rituximab → rituximab maintenance | PFS | NCT01415752 |
| Bendamustine-rituximab → rituximab-lenalidomide maintenance | |||||
| Bendamustine, rituximab, and bortezomib (Velcade) → rituximab maintenance | |||||
| Bendamustine, rituximab, and bortezomib (Velcade) → rituximab-lenalidomide maintenance | |||||
| SHINE | 3 | 523* | Bendamustine-rituximab → rituximab maintenance | PFS | NCT01776840 |
| Bendamustine-rituximab-ibrutinib → rituximab-ibrutinib maintenance | |||||
| ACE-LY-308 | 3 | 546† | Bendamustine-rituximab → rituximab maintenance | PFA | NCT02972840 |
| Bendamustine-rituximab-acalabrutinib → rituximab-acalabrutinib maintenance | |||||
| MCL-R2 Elderly | 3 | 633 | First: R-CHOP vs R-CHOP/R-HAD; second: rituximab maintenance vs rituximab-lenalidomide maintenance | PFS | NCT01865110 |
| ENRICH | 2/3 | 400 | Rituximab chemotherapy with maintenance rituximab vs ibrutinib-rituximab with maintenance rituximab | PFS | N/A |
| Chemotherapy free | |||||
| WINDOW I | 2 | 131 | Part 1: chemotherapy-free ibrutinib-rituximab treatment | ORR | NCT02427620 |
| WINDOW II | 2 | 50 | Group 3: chemotherapy-free venetoclax-ibrutinib-rituximab treatment | CR | NCT03710772 |
| ENRICH | 2/3 | 400 | Chemotherapy-free arm with ibrutinib-rituximab and a rituximab maintenance arm | PFS | N/A |
| ALR | 2 | 24 | Induction: acalabrutinib-lenalidomide-rituximab cycles 1-12; maintenance: cycles 13-POD | MRD-negative CR | NCT03863184 |
| VLR | 1 | 28 | Venetoclax-lenalidomide-rituximab cycles 1-12 | MTD | NCT03523975 |
ACE-LY-308 study, bendamustine-rituximab (BR) with rituximab maintenance vs BR plus acalabrutinib (A) with AR maintenance; N/A, not applicable; SHINE, bendamustine-rituximab (BR) with rituximab maintenance vs BR plus ibrutinib (I) with IR maintenance.
Bendamustine-rituximab with or without ibrutinib maintenance.
Bendamustine-rituximab with or without acalabrutinib maintenance.