Selected planned and ongoing frontline studies in MCL
| Study name (identifier) . | Phase . | Treatment(s) . | Key inclusion criteria . |
|---|---|---|---|
| ECOG-ACRIN EA4181 (NCT04115631) | 2 | BR/R-HDAC vs BR + acalabrutinib vs BR/R-HDAC + acalabrutinib | ≤70 y |
| ENRICH (EudraCT: 2015-000832-13) | 2/3 | Ibrutinib + rituximab vs R-CHOP or BR followed by RM | ≥60 y |
| MANGROVE (NCT04002297) | 3 | Zanubrutinib + rituximab vs BR | ≥70 y or ≥60 and transplant ineligible |
| A052101 (NCT05976763) | 3 | Continuous vs intermittent zanubrutinib + rituximab in patients with a CR | ≥70 y or ≥60 and transplant ineligible |
| OAsIs II (NCT04802590) | 2 | Ibrutinib + antiCD20 monoclonal antibody alone vs with venetoclax | ≤80 y |
| TrAVeRse (NCT05951959) | 2 | Acalabrutinib + venetoclax + rituximab | - |
| NCT04855695 | 2 | Acalabrutinib + venetoclax + obinutuzumab | TP53 mutated or ASCT ineligible (cohort B) TP53 wild-type and ASCT eligible (cohort C) |
| CARMAN (EuCT 2022-502405-15-00) | 2 | Ibrutinib + rituximab → ibrutinib + R-CHOP or ibrutinib monotherapy → brexucabtagene → ibrutinib maintenace vs ibrutinib + R-CHOP/R-DHAP → ASCT (≤65 y) or ibrutinib + R-CHOP or BR (>65 y)→ ibrutinib and RM | Age ≤75 y High intermediate or high MIPI-c and/or TP53 mutation or p53 expression >50% |
| NCT05861050 | 1/2 | Glofitamab (with obinutuzumab pretreatment), venetoclax, and lenalidomide | ≥1 high-risk feature: blastoid/pleomorphic, Ki-67 ≥ 50%, TP53 aberration or p53 overexpression, complex karyotype, high MIPI, bulky disease, other high-risk mutations |
| MCL Elderly III (Eudra CT 2020-002935-30) | 2 | Ibrutinib + venetoclax + rituximab vs BR + ibrutinib | ≥60 and transplant ineligible |
| ALTAMIRA (NCT05214183) | 2 | Acalabrutinib + rituximab | ≥60 and transplant ineligible |
| WINDOW-3 (NCT05495464) | 1 | Acalabrutinib + rituximab → brexucabtagene | High-risk including high MIPI-c, blastoid, Ki-67 ≥ 50%, TP53 aberrations or other high-risk mutations, or bulky disease |
| Study name (identifier) . | Phase . | Treatment(s) . | Key inclusion criteria . |
|---|---|---|---|
| ECOG-ACRIN EA4181 (NCT04115631) | 2 | BR/R-HDAC vs BR + acalabrutinib vs BR/R-HDAC + acalabrutinib | ≤70 y |
| ENRICH (EudraCT: 2015-000832-13) | 2/3 | Ibrutinib + rituximab vs R-CHOP or BR followed by RM | ≥60 y |
| MANGROVE (NCT04002297) | 3 | Zanubrutinib + rituximab vs BR | ≥70 y or ≥60 and transplant ineligible |
| A052101 (NCT05976763) | 3 | Continuous vs intermittent zanubrutinib + rituximab in patients with a CR | ≥70 y or ≥60 and transplant ineligible |
| OAsIs II (NCT04802590) | 2 | Ibrutinib + antiCD20 monoclonal antibody alone vs with venetoclax | ≤80 y |
| TrAVeRse (NCT05951959) | 2 | Acalabrutinib + venetoclax + rituximab | - |
| NCT04855695 | 2 | Acalabrutinib + venetoclax + obinutuzumab | TP53 mutated or ASCT ineligible (cohort B) TP53 wild-type and ASCT eligible (cohort C) |
| CARMAN (EuCT 2022-502405-15-00) | 2 | Ibrutinib + rituximab → ibrutinib + R-CHOP or ibrutinib monotherapy → brexucabtagene → ibrutinib maintenace vs ibrutinib + R-CHOP/R-DHAP → ASCT (≤65 y) or ibrutinib + R-CHOP or BR (>65 y)→ ibrutinib and RM | Age ≤75 y High intermediate or high MIPI-c and/or TP53 mutation or p53 expression >50% |
| NCT05861050 | 1/2 | Glofitamab (with obinutuzumab pretreatment), venetoclax, and lenalidomide | ≥1 high-risk feature: blastoid/pleomorphic, Ki-67 ≥ 50%, TP53 aberration or p53 overexpression, complex karyotype, high MIPI, bulky disease, other high-risk mutations |
| MCL Elderly III (Eudra CT 2020-002935-30) | 2 | Ibrutinib + venetoclax + rituximab vs BR + ibrutinib | ≥60 and transplant ineligible |
| ALTAMIRA (NCT05214183) | 2 | Acalabrutinib + rituximab | ≥60 and transplant ineligible |
| WINDOW-3 (NCT05495464) | 1 | Acalabrutinib + rituximab → brexucabtagene | High-risk including high MIPI-c, blastoid, Ki-67 ≥ 50%, TP53 aberrations or other high-risk mutations, or bulky disease |