Clinical trial NCT04508647 - References

Follicular Lymphoma — Ublituximab Followed by Response-driven Addition of Umbralisib for Treatment-naive Follicular or Marginal Zone Lymphoma

Citation(s)

•   Ardeshna KM, Qian W, Smith P, Braganca N, Lowry L, Patrick P, Warden J, Stevens L, Pocock CF, Miall F, Cunningham D, Davies J, Jack A, Stephens R, Walewski J, Ferhanoglu B, Bradstock K, Linch DC
  Rituximab versus a watch-and-wait approach in patients with advanced-stage, asymptomatic, non-bulky follicular lymphoma: an open-label randomised phase 3 trial. Lancet Oncol. 2014 Apr;15(4):424-35. doi: 10.1016/S1470-2045(14)70027-0. Epub 2014 Mar 4.
•   Armitage JO, Longo DL
  Is watch and wait still acceptable for patients with low-grade follicular lymphoma? Blood. 2016 Jun 9;127(23):2804-8. doi: 10.1182/blood-2015-11-632745. Epub 2016 Mar 18.
•   Campo E, Swerdlow SH, Harris NL, Pileri S, Stein H, Jaffe ES
  The 2008 WHO classification of lymphoid neoplasms and beyond: evolving concepts and practical applications. Blood. 2011 May 12;117(19):5019-32. doi: 10.1182/blood-2011-01-293050. Epub 2011 Feb 7.
•   Cheson BD, Fisher RI, Barrington SF, Cavalli F, Schwartz LH, Zucca E, Lister TA; Alliance, Australasian Leukaemia and Lymphoma Group; Eastern Cooperative Oncology Group; European Mantle Cell Lymphoma Consortium; Italian Lymphoma Foundation; European Organisation for Research; Treatment of Cancer/Dutch Hemato-Oncology Group; Grupo Espanol de Medula Osea; German High-Grade Lymphoma Study Group; German Hodgkin's Study Group; Japanese Lymphorra Study Group; Lymphoma Study Association; NCIC Clinical Trials Group; Nordic Lymphoma Study Group; Southwest Oncology Group; United Kingdom National Cancer Research Institute
  Recommendations for initial evaluation, staging, and response assessment of Hodgkin and non-Hodgkin lymphoma: the Lugano classification. J Clin Oncol. 2014 Sep 20;32(27):3059-68. doi: 10.1200/JCO.2013.54.8800.
•   Conconi A, Martinelli G, Thieblemont C, Ferreri AJ, Devizzi L, Peccatori F, Ponzoni M, Pedrinis E, Dell'Oro S, Pruneri G, Filipazzi V, Dietrich PY, Gianni AM, Coiffier B, Cavalli F, Zucca E
  Clinical activity of rituximab in extranodal marginal zone B-cell lymphoma of MALT type. Blood. 2003 Oct 15;102(8):2741-5. doi: 10.1182/blood-2002-11-3496. Epub 2003 Jul 3.
•   Federico M, Bellei M, Marcheselli L, Luminari S, Lopez-Guillermo A, Vitolo U, Pro B, Pileri S, Pulsoni A, Soubeyran P, Cortelazzo S, Martinelli G, Martelli M, Rigacci L, Arcaini L, Di Raimondo F, Merli F, Sabattini E, McLaughlin P, Solal-Celigny P
  Follicular lymphoma international prognostic index 2: a new prognostic index for follicular lymphoma developed by the international follicular lymphoma prognostic factor project. J Clin Oncol. 2009 Sep 20;27(27):4555-62. doi: 10.1200/JCO.2008.21.3991. Epub 2009 Aug 3.
•   Fisher RI, LeBlanc M, Press OW, Maloney DG, Unger JM, Miller TP
  New treatment options have changed the survival of patients with follicular lymphoma. J Clin Oncol. 2005 Nov 20;23(33):8447-52. doi: 10.1200/JCO.2005.03.1674. Epub 2005 Oct 17.
•   Friedberg JW, Taylor MD, Cerhan JR, Flowers CR, Dillon H, Farber CM, Rogers ES, Hainsworth JD, Wong EK, Vose JM, Zelenetz AD, Link BK
  Follicular lymphoma in the United States: first report of the national LymphoCare study. J Clin Oncol. 2009 Mar 10;27(8):1202-8. doi: 10.1200/JCO.2008.18.1495. Epub 2009 Feb 9.
•   Gopal AK, Kahl BS, de Vos S, Wagner-Johnston ND, Schuster SJ, Jurczak WJ, Flinn IW, Flowers CR, Martin P, Viardot A, Blum KA, Goy AH, Davies AJ, Zinzani PL, Dreyling M, Johnson D, Miller LL, Holes L, Li D, Dansey RD, Godfrey WR, Salles GA
  PI3Kdelta inhibition by idelalisib in patients with relapsed indolent lymphoma. N Engl J Med. 2014 Mar 13;370(11):1008-18. doi: 10.1056/NEJMoa1314583. Epub 2014 Jan 22.
•   Gribben JG
  How I treat indolent lymphoma. Blood. 2007 Jun 1;109(11):4617-26. doi: 10.1182/blood-2006-10-041863. Epub 2007 Feb 20.
•   Horn H, Schmelter C, Leich E, Salaverria I, Katzenberger T, Ott MM, Kalla J, Romero M, Siebert R, Rosenwald A, Ott G
  Follicular lymphoma grade 3B is a distinct neoplasm according to cytogenetic and immunohistochemical profiles. Haematologica. 2011 Sep;96(9):1327-34. doi: 10.3324/haematol.2011.042531. Epub 2011 Jun 9.
•   Horning SJ, Rosenberg SA
  The natural history of initially untreated low-grade non-Hodgkin's lymphomas. N Engl J Med. 1984 Dec 6;311(23):1471-5. doi: 10.1056/NEJM198412063112303.
•   Johnson PW, Rohatiner AZ, Whelan JS, Price CG, Love S, Lim J, Matthews J, Norton AJ, Amess JA, Lister TA
  Patterns of survival in patients with recurrent follicular lymphoma: a 20-year study from a single center. J Clin Oncol. 1995 Jan;13(1):140-7. doi: 10.1200/JCO.1995.13.1.140.
•   Kahl BS, Hong F, Williams ME, Gascoyne RD, Wagner LI, Krauss JC, Habermann TM, Swinnen LJ, Schuster SJ, Peterson CG, Sborov MD, Martin SE, Weiss M, Ehmann WC, Horning SJ
  Rituximab extended schedule or re-treatment trial for low-tumor burden follicular lymphoma: eastern cooperative oncology group protocol e4402. J Clin Oncol. 2014 Oct 1;32(28):3096-102. doi: 10.1200/JCO.2014.56.5853. Epub 2014 Aug 25.
•   Kahl BS
  Follicular lymphoma: are we ready for a risk-adapted approach? Hematology Am Soc Hematol Educ Program. 2017 Dec 8;2017(1):358-364. doi: 10.1182/asheducation-2017.1.358.
•   Kalpadakis C, Pangalis GA, Angelopoulou MK, Vassilakopoulos TP
  Treatment of splenic marginal zone lymphoma. Best Pract Res Clin Haematol. 2017 Mar-Jun;30(1-2):139-148. doi: 10.1016/j.beha.2016.07.004. Epub 2016 Nov 4.
•   Kamdar MK, Smith SM
  Extranodal Marginal Zone Lymphoma: No Longer Just a Sidekick. J Clin Oncol. 2017 Jun 10;35(17):1872-1878. doi: 10.1200/JCO.2017.72.2835. Epub 2017 Apr 27.
•   Lannutti BJ, Meadows SA, Herman SE, Kashishian A, Steiner B, Johnson AJ, Byrd JC, Tyner JW, Loriaux MM, Deininger M, Druker BJ, Puri KD, Ulrich RG, Giese NA
  CAL-101, a p110delta selective phosphatidylinositol-3-kinase inhibitor for the treatment of B-cell malignancies, inhibits PI3K signaling and cellular viability. Blood. 2011 Jan 13;117(2):591-4. doi: 10.1182/blood-2010-03-275305. Epub 2010 Oct 19.
•   Link BK, Maurer MJ, Nowakowski GS, Ansell SM, Macon WR, Syrbu SI, Slager SL, Thompson CA, Inwards DJ, Johnston PB, Colgan JP, Witzig TE, Habermann TM, Cerhan JR
  Rates and outcomes of follicular lymphoma transformation in the immunochemotherapy era: a report from the University of Iowa/MayoClinic Specialized Program of Research Excellence Molecular Epidemiology Resource. J Clin Oncol. 2013 Sep 10;31(26):3272-8. doi: 10.1200/JCO.2012.48.3990. Epub 2013 Jul 29.
•   Lunning MA, Vose JM, Schreeder MT, et al: Ublituximab, a novel glycoengineered anti-CD20 mAb, in combination with TGR-1202, a next generation once daily PI3Kdelta inhibitor, demonstrates activity in heavily pretreated and high-risk chronic lymphocytic leukemia and B-cell lymphoma, American Society of Hematology
  San Francisco, CA, 2014
•   Maddocks K, Barr PM, Cheson BD, Little RF, Baizer L, Kahl BS, Leonard JP, Fowler N, Gordon LI, Link BK, Friedberg JW, Ansell SM
  Recommendations for Clinical Trial Development in Follicular Lymphoma. J Natl Cancer Inst. 2016 Dec 31;109(3):djw255. doi: 10.1093/jnci/djw255. Print 2017 Mar.
•   Mato AR, Shah NN, Jurczak W, Cheah CY, Pagel JM, Woyach JA, Fakhri B, Eyre TA, Lamanna N, Patel MR, Alencar A, Lech-Maranda E, Wierda WG, Coombs CC, Gerson JN, Ghia P, Le Gouill S, Lewis DJ, Sundaram S, Cohen JB, Flinn IW, Tam CS, Barve MA, Kuss B, Taylor J, Abdel-Wahab O, Schuster SJ, Palomba ML, Lewis KL, Roeker LE, Davids MS, Tan XN, Fenske TS, Wallin J, Tsai DE, Ku NC, Zhu E, Chen J, Yin M, Nair B, Ebata K, Marella N, Brown JR, Wang M
  Pirtobrutinib in relapsed or refractory B-cell malignancies (BRUIN): a phase 1/2 study. Lancet. 2021 Mar 6;397(10277):892-901. doi: 10.1016/S0140-6736(21)00224-5.
•   Morschhauser F, Fowler NH, Feugier P, Bouabdallah R, Tilly H, Palomba ML, Fruchart C, Libby EN, Casasnovas RO, Flinn IW, Haioun C, Maisonneuve H, Ysebaert L, Bartlett NL, Bouabdallah K, Brice P, Ribrag V, Daguindau N, Le Gouill S, Pica GM, Martin Garcia-Sancho A, Lopez-Guillermo A, Larouche JF, Ando K, Gomes da Silva M, Andre M, Zachee P, Sehn LH, Tobinai K, Cartron G, Liu D, Wang J, Xerri L, Salles GA; RELEVANCE Trial Investigators
  Rituximab plus Lenalidomide in Advanced Untreated Follicular Lymphoma. N Engl J Med. 2018 Sep 6;379(10):934-947. doi: 10.1056/NEJMoa1805104.
•   Pastore A, Jurinovic V, Kridel R, Hoster E, Staiger AM, Szczepanowski M, Pott C, Kopp N, Murakami M, Horn H, Leich E, Moccia AA, Mottok A, Sunkavalli A, Van Hummelen P, Ducar M, Ennishi D, Shulha HP, Hother C, Connors JM, Sehn LH, Dreyling M, Neuberg D, Moller P, Feller AC, Hansmann ML, Stein H, Rosenwald A, Ott G, Klapper W, Unterhalt M, Hiddemann W, Gascoyne RD, Weinstock DM, Weigert O
  Integration of gene mutations in risk prognostication for patients receiving first-line immunochemotherapy for follicular lymphoma: a retrospective analysis of a prospective clinical trial and validation in a population-based registry. Lancet Oncol. 2015 Sep;16(9):1111-1122. doi: 10.1016/S1470-2045(15)00169-2. Epub 2015 Aug 6.
•   Relander T, Johnson NA, Farinha P, Connors JM, Sehn LH, Gascoyne RD
  Prognostic factors in follicular lymphoma. J Clin Oncol. 2010 Jun 10;28(17):2902-13. doi: 10.1200/JCO.2009.26.1693. Epub 2010 Apr 12. Erratum In: J Clin Oncol. 2010 Oct 20;28(30):4664.
•   Rummel MJ, Niederle N, Maschmeyer G, Banat GA, von Grunhagen U, Losem C, Kofahl-Krause D, Heil G, Welslau M, Balser C, Kaiser U, Weidmann E, Durk H, Ballo H, Stauch M, Roller F, Barth J, Hoelzer D, Hinke A, Brugger W; Study group indolent Lymphomas (StiL)
  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. Lancet. 2013 Apr 6;381(9873):1203-10. doi: 10.1016/S0140-6736(12)61763-2. Epub 2013 Feb 20. Erratum In: Lancet. 2013 Apr 6;381(9873):1184.
•   Salles G, Seymour JF, Offner F, Lopez-Guillermo A, Belada D, Xerri L, Feugier P, Bouabdallah R, Catalano JV, Brice P, Caballero D, Haioun C, Pedersen LM, Delmer A, Simpson D, Leppa S, Soubeyran P, Hagenbeek A, Casasnovas O, Intragumtornchai T, Ferme C, da Silva MG, Sebban C, Lister A, Estell JA, Milone G, Sonet A, Mendila M, Coiffier B, Tilly H
  Rituximab maintenance for 2 years in patients with high tumour burden follicular lymphoma responding to rituximab plus chemotherapy (PRIMA): a phase 3, randomised controlled trial. Lancet. 2011 Jan 1;377(9759):42-51. doi: 10.1016/S0140-6736(10)62175-7. Epub 2010 Dec 20. Erratum In: Lancet. 2011 Apr 2;377(9772):1154.
•   Sawas A, Farber CM, Schreeder MT, Khalil MY, Mahadevan D, Deng C, Amengual JE, Nikolinakos PG, Kolesar JM, Kuhn JG, Sportelli P, Miskin HP, O'Connor OA
  A phase 1/2 trial of ublituximab, a novel anti-CD20 monoclonal antibody, in patients with B-cell non-Hodgkin lymphoma or chronic lymphocytic leukaemia previously exposed to rituximab. Br J Haematol. 2017 Apr;177(2):243-253. doi: 10.1111/bjh.14534. Epub 2017 Feb 21.
•   Solal-Celigny P, Lepage E, Brousse N, Tendler CL, Brice P, Haioun C, Gabarre J, Pignon B, Tertian G, Bouabdallah R, Rossi JF, Doyen C, Coiffier B
  Doxorubicin-containing regimen with or without interferon alfa-2b for advanced follicular lymphomas: final analysis of survival and toxicity in the Groupe d'Etude des Lymphomes Folliculaires 86 Trial. J Clin Oncol. 1998 Jul;16(7):2332-8. doi: 10.1200/JCO.1998.16.7.2332.
•   Solal-Celigny P
  [Treatment of malignant low-grade lymphoma. Follicular Lymphoma Study Group]. Rev Med Interne. 1998;19 Suppl 1:18S-20S. doi: 10.1016/s0248-8663(98)80005-2. No abstract available. French.
•   Swenson WT, Wooldridge JE, Lynch CF, Forman-Hoffman VL, Chrischilles E, Link BK
  Improved survival of follicular lymphoma patients in the United States. J Clin Oncol. 2005 Aug 1;23(22):5019-26. doi: 10.1200/JCO.2005.04.503. Epub 2005 Jun 27.
•   Thieblemont C
  Improved biological insight and influence on management in indolent lymphoma. Talk 3: update on nodal and splenic marginal zone lymphoma. Hematology Am Soc Hematol Educ Program. 2017 Dec 8;2017(1):371-378. doi: 10.1182/asheducation-2017.1.371.
•   Williams ME, Hong F, Gascoyne RD, Wagner LI, Krauss JC, Habermann TM, Swinnen LJ, Schuster SJ, Peterson CG, Sborov MD, Martin SE, Weiss M, Ehmann WC, Horning SJ, Kahl BS
  Rituximab extended schedule or retreatment trial for low tumour burden non-follicular indolent B-cell non-Hodgkin lymphomas: Eastern Cooperative Oncology Group Protocol E4402. Br J Haematol. 2016 Jun;173(6):867-75. doi: 10.1111/bjh.14007. Epub 2016 Mar 11.

Ublituximab as Initial Therapy for Treatment-naive Follicular or Marginal Zone Lymphoma With Response-driven Addition of Umbralisib for Suboptimal Response

Details for clinical trial NCT04508647