Table 1. Current clinical trials in mantle cell lymphoma (MCL).
Notable current clinical trials in MCL organized by clinical indication. Certain trials appear twice given their design to answer multiple clinical questions. ASCT, autologous stem cell transplant; BCL-2, B-cell lymphoma 2; BR, bendamustine–rituximab; BTK, Bruton’s tyrosine kinase; CAR-T; chimeric antigen receptor T-cell; HDAC, histone deacetylase; R-Hyper-CVAD, rituximab plus fractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone plus methotrexate and cytarabine; MRD, minimal residual disease; PI3K, phosphoinositide 3-kinase; R 2, lenalidomide plus rituximab; R-CHOP, rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone; R-DHAP, rituximab, dexamethasone, cytarabine, and cisplatin; R-HAD, rituximab, high-dose cytarabine, and dexamethasone.
| Category of
therapy |
Study design or regimen | Target or drug class | Clinical trials
identifier |
Status | Phase |
|---|---|---|---|---|---|
| Fit induction | R-CHOP/R-DHAP + ASCT vs.
R-CHOP/R-DHAP + ibrutinib vs. R-CHOP/R-DHAP + ibrutinib + ASCT |
BTK |
NCT02858258
(TRIANGLE) |
Recruiting | Phase III |
| R-HyperCVAD + Ibrutinib | BTK | NCT02427620 | Recruiting | Phase II | |
| Unfit induction | BR + ibrutinib | BTK |
NCT01776840
(SHINE) |
Active | Phase III |
| R-CHOP/R-HAD vs. R-CHOP | Cytarabine | NCT01865110 | Recruiting | Phase III | |
| BR + acalabrutinib | BTK | NCT02972840 | Recruiting | Phase III | |
| Bendamustine + obinutuzumab | Anti-CD20 | NCT03311126 | Recruiting | Phase II | |
| Maintenance | Rituximab vs. ASCT + rituximab in
MRD-negative patients |
Anti-CD20 | NCT03267433 | Recruiting | Phase III |
| ASCT +/- ibrutinib maintenance vs
ibrutinib maintenance (no ASCT); rituximab may be added to each arm |
BTK |
NCT02858258
(TRIANGLE) |
Recruiting | Phase III | |
| Ibrutinib without ASCT | BTK | NCT02242097 | Recruiting | Phase II | |
| R 2 vs. rituximab maintenance | Anti-CD20 + Imid | NCT01865110 | Recruiting | Phase III | |
| Relapsed MCL | Obinutuzumab + GDC-0199 +
Ibrutinib |
Anti-CD20, BCL-2, BTK | NCT02558816 | Recruiting | Phase II |
| Obinutuzumab + Ibrutinib | Anti-CD20 + BTK | NCT02736617 | Recruiting | Phase II | |
| KTE-C19 | CAR-T |
NCT02601313
(ZUMA-2) |
Recruiting | Phase II | |
| JCAR017 | CAR-T |
NCT02631044
(TRANSCEND) |
Recruiting | Phase I | |
| Ixazomib + Ibrutinib | Proteasome + BTK | NCT03323151 | Recruiting | Phase II | |
| Bortezomib + Ibrutinib | Proteasome + BTK | NCT02356458 | Recruiting | Phase II | |
| INCB050465 | PI3K | NCT03235544 | Recruiting | Phase II | |
| Entospletinib | Syc | NCT01799889 | Active | Phase II | |
| Vorinostat | HDAC | NCT00875056 | Recruiting | Phase II | |
| Enzalutamide | Androgen | NCT02489123 | Recruiting | Phase II |