Phase 1b dose-finding study of rituximab, lenalidomide, and ibrutinib (R2I) in patients with relapsed/refractory mantle cell lymphoma

References

• Zhou Y, Wang H, Fang W, et al. Incidence trends of mantle cell lymphoma in the United States between 1992 and 2004. Cancer. 2008;113(4):791–798. doi:10.1002/cncr.23608
   PubMed Web of Science ®Google Scholar
• Al-Hamadani M, Habermann TM, Cerhan JR, et al. Non-Hodgkin lymphoma subtype distribution, geodemographic patterns, and survival in the US: a longitudinal analysis of the national cancer data base from 1998 to 2011. Am J Hematol. 2015;90(9):790–795. doi:10.1002/ajh.24086
   PubMed Web of Science ®Google Scholar
• Goy A, Kahl B. Mantle cell lymphoma: the promise of new treatment options. Crit Rev Oncol Hematol. 2011;80(1):69–86. doi:10.1016/j.critrevonc.2010.09.003
   PubMed Web of Science ®Google Scholar
• Geisler CH, Kolstad A, Laurell A, et al. Long-term progression-free survival of mantle cell lymphoma after intensive front-line immunochemotherapy with in vivo-purged stem cell rescue: a nonrandomized phase 2 multicenter study by the nordic lymphoma group. Blood. 2008;112(7):2687–2693. doi:10.1182/blood-2008-03-147025
   PubMed Web of Science ®Google Scholar
• LaCasce AS, Vandergrift JL, Rodriguez MA, et al. Comparative outcome of initial therapy for younger patients with mantle cell lymphoma: an analysis from the NCCN NHL database. Blood. 2012;119(9):2093–2099. doi:10.1182/blood-2011-07-369629
   PubMed Web of Science ®Google Scholar
• Rummel MJ, Niederle N, Maschmeyer G, et al. Bendamustine plus rituximab versus CHOP plus rituximab as first-line treatment for patients with indolent and mantle-cell lymphomas: an open-label, multicentre, randomised, phase 3 non-inferiority trial [published correction appears in lancet. 2013 apr 6;381(9873):1184]. Lancet. 2013;381(9873):1203–1210. doi:10.1016/S0140-6736(12)61763-2
   PubMed Web of Science ®Google Scholar
• Flinn IW, van der Jagt R, Kahl B, et al. First-Line treatment of patients with indolent Non-Hodgkin lymphoma or Mantle-Cell lymphoma with bendamustine plus rituximab versus R-CHOP or R-CVP: results of the BRIGHT 5-Year Follow-Up study. J Clin Oncol. 2019;37(12):984–991. doi:10.1200/JCO.18.00605
   PubMed Web of Science ®Google Scholar
• Kumar A, Martin P, Wang M, et al. Real-World treatment patterns and outcomes of 3455 previously untreated mantle cell lymphoma patients in US routine clinical practice [supplement abstract 153. ]. Hematological Oncology. 2021;39(S2):223–225. doi:10.1002/hon.65_2280
   Google Scholar
• Narkhede M, Goyal G, Shea L, et al. Evaluating real-world treatment patterns and outcomes of mantle cell lymphoma. Blood Adv. 2022;6(14):4122–4131. doi:10.1182/bloodadvances.2022007247
   PubMed Web of Science ®Google Scholar
• Kumar A, Sha F, Toure A, et al. Patterns of survival in patients with recurrent mantle cell lymphoma in the modern era: progressive shortening in response duration and survival after each relapse. Blood Cancer J. 2019;9(6):50. Published 2019 May 20. doi:10.1038/s41408-019-0209-5
   PubMed Web of Science ®Google Scholar
• Eskelund CW, Dahl C, Hansen JW, et al. TP53 mutations identify younger mantle cell lymphoma patients who do not benefit from intensive chemoimmunotherapy. Blood. 2017;130(17):1903–1910. doi:10.1182/blood-2017-04-779736
   PubMed Web of Science ®Google Scholar
• Ruan J, Martin P, Christos P, et al. Five-year follow-up of lenalidomide plus rituximab as initial treatment of mantle cell lymphoma. Blood. 2018;132(19):2016–2025. doi:10.1182/blood-2018-07-859769
   PubMed Web of Science ®Google Scholar
• Zhang L, Qian Z, Cai Z, et al. Synergistic antitumor effects of lenalidomide and rituximab on mantle cell lymphoma in vitro and in vivo. Am J Hematol. 2009;84(9):553–559. doi:10.1002/ajh.21468
   PubMed Web of Science ®Google Scholar
• Goy A, Sinha R, Williams ME, et al. Single-agent lenalidomide in patients with mantle-cell lymphoma who relapsed or progressed after or were refractory to bortezomib: phase II MCL-001 (EMERGE) study. J Clin Oncol. 2013;31(29):3688–3695. doi:10.1200/JCO.2013.49.2835
   PubMed Web of Science ®Google Scholar
• Ruan J, Shah B, Martin P, et al. Clinical experience with lenalidomide alone or in combination with rituximab in indolent B-cell and mantle cell lymphomas. Ann Oncol. 2016;27(7):1226–1234. doi:10.1093/annonc/mdw158
   PubMed Web of Science ®Google Scholar
• Rule S, Dreyling MH, Goy AH, et al. Long-Term outcomes with ibrutinib versus the prior regimen: a pooled analysis in relapsed/refractory (R/R) mantle cell lymphoma (MCL) with up to 7.5 years of extended follow-up [supplement abstract 623]. Blood. 2019;134(Supplement_1):1538–1538. doi:10.1182/blood-2019-124691
   Google Scholar
• Wang M, Fayad L, Wagner-Bartak N, et al. Lenalidomide in combination with rituximab for patients with relapsed or refractory mantle-cell lymphoma: a phase 1/2 clinical trial. Lancet Oncol. 2012;13(7):716–723. doi:10.1016/S1470-2045(12)70200-0
   PubMed Web of Science ®Google Scholar
• Wiestner A. Targeting B-Cell receptor signaling for anticancer therapy: the bruton’s tyrosine kinase inhibitor ibrutinib induces impressive responses in B-cell malignancies. J Clin Oncol. 2013;31(1):128–130. doi:10.1200/JCO.2012.44.4281
   PubMed Web of Science ®Google Scholar
• Wang ML, Lee H, Chuang H, et al. Ibrutinib in combination with rituximab in relapsed or refractory mantle cell lymphoma: a single-Centre, open-label, phase 2 trial. Lancet Oncol. 2016;17(1):48–56. doi:10.1016/S1470-2045(15)00438-6
   PubMed Web of Science ®Google Scholar
• Goy A, Ramchandren R, Ghosh N, et al. Ibrutinib plus lenalidomide and rituximab has promising activity in relapsed/refractory non-germinal center B-cell-like DLBCL. Blood. 2019;134(13):1024–1036. doi:10.1182/blood.2018891598
   PubMed Web of Science ®Google Scholar
• Cheson BD, Pfistner B, Juweid ME, et al. Revised response criteria for malignant lymphoma. J Clin Oncol. 2007;25(5):579–586. doi:10.1200/JCO.2006.09.2403
   PubMed Web of Science ®Google Scholar
• Giné E, de la Cruz F, Jiménez Ubieto A, et al. Ibrutinib in combination with rituximab for indolent clinical forms of mantle cell lymphoma (IMCL-2015): a multicenter, Open-Label, Single-Arm, phase II trial. J Clin Oncol. 2022;40(11):1196–1205. doi:10.1200/JCO.21.02321
   PubMed Web of Science ®Google Scholar
• Kojima A, Tanaka Y, Kimura Y, et al. Multiple myeloma patients with Lenalidomide-Associated skin rash have a favorable prognosis [abstract 653]. Blood. 2016;128(22):4532–4532. doi:10.1182/blood.V128.22.4532.4532
   Web of Science ®Google Scholar
• Tinsley SM, Kurtin SE, Ridgeway JA. Practical management of Lenalidomide-Related rash. Clin Lymphoma Myeloma Leuk. 2015;15 Suppl: s 64–S69. doi:10.1016/j.clml.2015.02.008
   Web of Science ®Google Scholar
• Wang ML, Rule S, Martin P, et al. Targeting BTK with ibrutinib in relapsed or refractory mantle-cell lymphoma. N Engl J Med. 2013;369(6):507–516. doi:10.1056/NEJMoa1306220
   PubMed Web of Science ®Google Scholar
• Jerkeman M, Eskelund CW, Hutchings M, et al. Ibrutinib, lenalidomide, and rituximab in relapsed or refractory mantle cell lymphoma (PHILEMON): a multicentre, open-label, single-arm, phase 2 trial. Lancet Haematol. 2018;5(3):e109–e116. doi:10.1016/S2352-3026(18)30018-8
   PubMed Web of Science ®Google Scholar
• Ujjani CS, Jung SH, Pitcher B, et al. Phase 1 trial of rituximab, lenalidomide, and ibrutinib in previously untreated follicular lymphoma: alliance A051103. Blood. 2016;128(21):2510–2516. doi:10.1182/blood-2016-06-718106
   PubMed Web of Science ®Google Scholar
• Sestier M, Hillis C, Fraser G, et al. Bruton’s tyrosine kinase inhibitors and cardiotoxicity: more than just atrial fibrillation. Curr Oncol Rep. 2021;23(10):113. Published 2021 Aug3. doi:10.1007/s11912-021-01102-1
   PubMed Web of Science ®Google Scholar
• Salem JE, Manouchehri A, Bretagne M, et al. Cardiovascular toxicities associated with ibrutinib. J Am Coll Cardiol. 2019;74(13):1667–1678. doi:10.1016/j.jacc.2019.07.056
   PubMed Web of Science ®Google Scholar
• Fazal M, Kapoor R, Cheng P, et al. Arrhythmia patterns in patients on ibrutinib. Front Cardiovasc Med. 2021;8:792310. Published 2022 Jan3. doi:10.3389/fcvm.2021.792310
   PubMed Web of Science ®Google Scholar
• Jerkeman M, Hutching M, Raty R, et al. Ibrutinib-Lenalidomide-Rituximab in Patients with Relapsed/Refractory Mantle Cell Lymphoma: final Results from the Nordic Lymphoma Group MCL6 (PHILEMON) Phase II Trial. Poster presented at the American Society of Hematology 2020 Meeting; December 5-8, 2020. https://ash.confex.com/ash/2020/webprogram/Paper133298.html.
   Google Scholar
• Dreyling M, Doordujin JK, Gine E, et al. Efficacy and safety of ibrutinib combined with standard first-line treatment or as substitute for autologous stem cell transplantation in younger patients with mantle cell lymphoma: results from the randomized TRIANGLE trial by the European MCL Network. Plenary scientific ­session. 64th American Society of Hematology Annual Meeting and Exposition; Dec 11, 2022; New Orleans, US.
   Google Scholar
• Wang ML, Jain P, Zhao S, et al. Ibrutinib-rituximab followed by R-HCVAD as frontline treatment for young patients (≤65 years) with mantle cell lymphoma (WINDOW-1): a single-arm, phase 2 trial. Lancet Oncol. 2022;23(3):406–415. doi:10.1016/S1470-2045(21)00638-0
   PubMed Web of Science ®Google Scholar