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5. P1156: MAGNIFY PHASE 3B STUDY OF LENALIDOMIDE + RITUXIMAB (R2) FOLLOWED BY MAINTENANCE IN RELAPSED/REFRACTORY INDOLENT NON-HODGKIN LYMPHOMA: COMPLETE INDUCTION PHASE ANALYSIS

Author

Lansigan, F., primary, Andorsky, D. J., additional, Coleman, M., additional, Yacoub, A., additional, Melear, J. M., additional, Fanning, S. R., additional, Kolibaba, K. S., additional, Reynolds, C., additional, Nowakowski, G. S., additional, Gharibo, M., additional, Ahn, J. R., additional, Li, J., additional, Rummel, M. J., additional, and Sharman, J. P., additional

Published
2022
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6. P671: TREATMENT SEQUENCES AND OUTCOMES OF PATIENTS WITH CLL TREATED WITH TARGETED AGENTS IN REAL-WORLD SETTINGS

Author

Mato, A. R., primary, Manzoor, B. S., additional, Coombs, C. C., additional, Lamanna, N., additional, Tuncer, H. H., additional, Brown, J. R., additional, Roeker, L. E., additional, Shadman, M., additional, Allan, J. N., additional, Ujjani, C., additional, Eichhorst, B., additional, Leslie, L., additional, Fleury, I., additional, Alhasani, H., additional, Rhodes, J., additional, Hill, B. T., additional, Barr, P. M., additional, Skarbnik, A., additional, Davids, M. S., additional, Bannerji, R., additional, Fuldeore, M., additional, Lansigan, F., additional, Schuh, A., additional, Pearson, L., additional, Fox, C. P., additional, Pivneva, I., additional, Popadic, L., additional, Guerin, A., additional, and Eyre, T. A., additional

Published
2022
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7. P675: TREATMENT OF HYPERTENSION IN PATIENTS RECEIVING BTK INHIBITORS: A MULTICENTER RETROSPECTIVE STUDY

Author

Shadman, M., primary, Voutsinas, J., additional, Fakhri, B., additional, Khajavian, S., additional, Spurgeon, S., additional, Stephens, D., additional, Skarnbik, A., additional, Mato, A., additional, Broome, C., additional, Gopal, A., additional, Smith, S., additional, Lynch, R., additional, Rainey, M., additional, Kim, S., additional, Barrett-Campbell, O., additional, Hemond, E., additional, Tsang, M., additional, Ermann, D., additional, Malakhov, N., additional, Rao, D., additional, Shakib Azar, M., additional, Morrigan, B., additional, Chauhan, A., additional, Plate, T., additional, Gooley, T., additional, Ryan, K., additional, Lansigan, F., additional, Hill, B., additional, Pongas, G., additional, Parikh, S., additional, Roeker, L., additional, Allan, J., additional, Cheng, R., additional, and Ujjani, C., additional

Published
2022
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8. Venetoclax retreatment of patients with chronic lymphocytic leukemia after a previous venetoclax-based regimen

Author

Thompson, MC, Harrup, RA, Coombs, CC, Roeker, LE, Pu, JJ, Choi, MY, Barr, PM, Allan, JN, Simkovic, M, Leslie, L, Rhodes, J, Chong, EA, Kamdar, M, Skarbnik, A, Lansigan, F, McCall, B, Saja, K, Dyer, MJS, Walter, HS, Lefebure, M, Thadani-Mulero, M, Boyer, M, Biondo, J, Sail, K, Manzoor, BS, Furman, R, Bantilan, KS, Goy, A, Feldman, T, Labella, D, Schuster, SJ, Park, J, Palomba, L, Zelenetz, A, Eyre, TA, Kater, AP, Seymour, JF, Mato, AR, Thompson, MC, Harrup, RA, Coombs, CC, Roeker, LE, Pu, JJ, Choi, MY, Barr, PM, Allan, JN, Simkovic, M, Leslie, L, Rhodes, J, Chong, EA, Kamdar, M, Skarbnik, A, Lansigan, F, McCall, B, Saja, K, Dyer, MJS, Walter, HS, Lefebure, M, Thadani-Mulero, M, Boyer, M, Biondo, J, Sail, K, Manzoor, BS, Furman, R, Bantilan, KS, Goy, A, Feldman, T, Labella, D, Schuster, SJ, Park, J, Palomba, L, Zelenetz, A, Eyre, TA, Kater, AP, Seymour, JF, and Mato, AR

Published
2022

11. PATIENTS WITH RELAPSED/REFRACTORY MARGINAL ZONE LYMPHOMA IN THE MAGNIFY PHASE 3B INTERIM ANALYSIS OF INDUCTION R2 FOLLOWED BY MAINTENANCE

Author

Coleman, M, primary, Andorsky, DJ, additional, Yacoub, A, additional, Melear, JM, additional, Fanning, SR, additional, Kolibaba, KS, additional, Lansigan, F, additional, Reynolds, C, additional, Nowakowski, G, additional, Gharibo, M, additional, Ahn, E, additional, Li, J, additional, Rummel, MJ, additional, and Sharman, JP, additional

Published
2021
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13. SUBGROUP ANALYSES OF ELDERLY PATIENTS AGED 70 YEARS IN MAGNIFY: A PHASE 3B INTERIM ANALYSIS OF INDUCTION R2 FOLLOWED BY MAINTENANCE IN RELAPSED/REFRACTORY INDOLENT NON-HODGKIN LYMPHOMA

Author

Lansigan, F, primary, Andorsky, DJ, additional, Coleman, M, additional, Yacoub, A, additional, Md, JMM, additional, Fanning, SR, additional, Kolibaba, KS, additional, Reynolds, C, additional, Nowakowski, G, additional, Gharibo, M, additional, Ahn, E, additional, Li, J, additional, Rummel, MJ, additional, and Sharman, JP, additional

Published
2021
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14. Final Result of DIAL (NCI10089), Randomized Phase 2 trial of Varlilumab combined with Nivolumab in patients with relapsed/refractory aggressive B‐cell non‐Hodgkin lymphoma.

Author

Soekojo, C. Y., Yin, J., Kline, J., Lazaryan, A., Bartlett, N., Geethakumari, P. Ramakrishnan, Awan, F., Karmali, R., Hernandez‐Ilizaliturri, F. J., Shune, L., Lansigan, F., Reeder, C., Diefenbach, C., Sharon, E., Mikula, E., Strand, C., Postovalova, E., Kotlov, N., Zornikova, K., and Bagaev, A.

Subjects
NON-Hodgkin's lymphoma, NIVOLUMAB
Abstract

Subgroup analysis of patients with confirmed prior CAR-T cell therapy showed similar ORR compared to overall cohort (5/33; 15%), not statistically different between arms; 3 responses were complete (Figure 1B). Final Result of DIAL (NCI10089), Randomized Phase 2 trial of Varlilumab combined with Nivolumab in patients with relapsed/refractory aggressive B-cell non-Hodgkin lymphoma B Introduction: b The prognosis for patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma (r/r B-NHL) is poor. [Extracted from the article]

Published
2023
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15. MATURE RESULTS FROM A PHASE II TRIAL OF BRENTUXIMAB VEDOTIN PLUS ADRIAMYCIN AND DACARBAZINE WITHOUT RADIATION IN NON‐BULKY LIMITED STAGE CLASSICAL HODGKIN LYMPHOMA

Author

Abramson, J. S., primary, Bengston, E. M., additional, Redd, R., additional, Barnes, J. A., additional, Takvorian, T., additional, Sokol, L., additional, Lansigan, F., additional, Armand, P., additional, Shah, B., additional, Jacobsen, E., additional, Martignetti, R., additional, Turba, E., additional, Metzler, S. R., additional, Patterson, V., additional, LaCasce, A. S., additional, and Bello, C. M., additional

Published
2021
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16. INDUCTION R2 FOLLOWED BY MAINTENANCE IN PATIENTS WITH RELAPSED/REFRACTORY MANTLE CELL LYMPHOMA: INTERIM ANALYSIS FROM THE PHASE 3B MAGNIFY STUDY

Author

Sharman, J. P., primary, Melear, J. M., additional, Yacoub, A., additional, Fanning, S. R., additional, Andorsky, D. J., additional, Nowakowski, G. S., additional, Rummel, M. J., additional, Lansigan, F., additional, Li, J., additional, Ahn, J. R., additional, Gharibo, M., additional, and Coleman, M., additional

Published
2021
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17. INDUCTION R 2 FOLLOWED BY MAINTENANCE IN PATIENTS WITH RELAPSED/REFRACTORY TRANSFORMED FOLLICULAR LYMPHOMA: INTERIM ANALYSIS FROM THE PHASE 3B MAGNIFY STUDY

Author

. Lansigan, F, primary, . Parameswaran, V, additional, . Yacoub, A, additional, . Reynolds, C. M, additional, . Shao, S. H, additional, . Moore, S. G, additional, . Coleman, M, additional, . Andorsky, D. J, additional, . Nowakowski, G. S, additional, . Rummel, M. J, additional, . Li, J, additional, . Ahn, J. R, additional, . Gharibo, M, additional, and . Sharman, J. P, additional

Published
2021
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18. SURVIVAL FOLLOWING FIRST RELAPSE IN YOUNGER PATIENTS WITH MANTLE CELL LYMPHOMA

Author

Karmali, R., primary, Donovan, A., additional, Wagner‐Johntson, N., additional, Messmer, M., additional, Mehta, A., additional, Anderson, J. K., additional, Reddy, N., additional, Kovach, A. E., additional, Landsburg, D. J., additional, Glenn, M., additional, Inwards, D. J., additional, Ristow, K., additional, Lansigan, F., additional, Kaplan, J. B., additional, Caimi, P. B., additional, Rajguru, S., additional, Evens, A., additional, Klein, A., additional, Umyarova, E., additional, Amengual, J. E., additional, Lue, J. K., additional, Diefenbach, C., additional, Epperla, N., additional, Barta, S. K., additional, Hernandez‐Ilizaliturri, F. J, additional, Handorf, E., additional, Villa, D., additional, Gerrie, A. S., additional, Li, S., additional, Mederios, J., additional, Wang, M., additional, Cohen, J., additional, Calzada, O., additional, Churnetski, M., additional, Hill, B., additional, Sawalha, Y., additional, Gerson, J. N., additional, Kothari, S., additional, Vose, J. M., additional, Bast, M., additional, Fenske, T. S., additional, Narayana Rao Gari, S., additional, Maddocks, K. J., additional, Bond, D., additional, Bachanova, V., additional, Kolla, B., additional, Chavez, J., additional, and Shah, B., additional

Published
2021
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19. Efficacy of bendamustine and rituximab in unfit patients with previously untreated chronic lymphocytic leukemia. Indirect comparison with ibrutinib in a real-world setting. A GIMEMA-ERIC and US study

Author

Cuneo, A, Mato, AR, Rigolin, GM, Piciocchi, A, Gentile, M, Laurenti, L, Allan, JN, Pagel, JM, Brander, DM, Hill, BT, Winter, A, Lamanna, N, Tam, CS, Jacobs, R, Lansigan, F, Barr, PM, Shadman, M, Skarbnik, AP, Pu, JJ, Sehgal, AR, Schuster, SJ, Shah, NN, Ujjani, CS, Roeker, L, Orlandi, EM, Billio, A, Trentin, L, Spacek, M, Marchetti, M, Tedeschi, A, Ilariucci, F, Gaidano, G, Doubek, M, Farina, L, Molica, S, Di Raimondo, F, Coscia, M, Mauro, FR, de la Serna, J, Medina Perez, A, Ferrarini, I, Cimino, G, Cavallari, M, Cucci, R, Vignetti, M, Foa, R, Ghia, P, Cuneo, A, Mato, AR, Rigolin, GM, Piciocchi, A, Gentile, M, Laurenti, L, Allan, JN, Pagel, JM, Brander, DM, Hill, BT, Winter, A, Lamanna, N, Tam, CS, Jacobs, R, Lansigan, F, Barr, PM, Shadman, M, Skarbnik, AP, Pu, JJ, Sehgal, AR, Schuster, SJ, Shah, NN, Ujjani, CS, Roeker, L, Orlandi, EM, Billio, A, Trentin, L, Spacek, M, Marchetti, M, Tedeschi, A, Ilariucci, F, Gaidano, G, Doubek, M, Farina, L, Molica, S, Di Raimondo, F, Coscia, M, Mauro, FR, de la Serna, J, Medina Perez, A, Ferrarini, I, Cimino, G, Cavallari, M, Cucci, R, Vignetti, M, Foa, R, and Ghia, P

Abstract

Limited information is available on the efficacy of front-line bendamustine and rituximab (BR) in chronic lymphocytic leukemia (CLL) with reduced renal function or coexisting conditions. We therefore analyzed a cohort of real-world patients and performed a matched adjusted indirect comparison with a cohort of patients treated with ibrutinib. One hundred and fifty-seven patients with creatinine clearance (CrCl) <70 mL/min and/or CIRS score >6 were treated with BR. The median age was 72 years; 69% of patients had ≥2 comorbidities and the median CrCl was 59.8 mL/min. 17.6% of patients carried TP53 disruption. The median progression-free survival (PFS) was 45 months; TP53 disruption was associated with a shorter PFS (P = 0.05). The overall survival (OS) at 12, 24, and 36 months was 96.2%, 90.1%, and 79.5%, respectively. TP53 disruption was associated with an increased risk of death (P = 0.01). Data on 162 patients ≥65 years treated with ibrutinib were analyzed and compared with 165 patients ≥65 years treated with BR. Factors predicting for a longer PFS at multivariable analysis in the total patient population treated with BR and ibrutinib were age (HR 1.06, 95% CI 1.02-1.10, P < 0.01) and treatment with ibrutinib (HR 0.55, 95% CI 0.33-0.93, P = 0.03). In a post hoc analysis of patients in advanced stage, a significant PFS advantage was observed in patient who had received ibrutinib (P = 0.03), who showed a trend for OS advantage (P = 0.08). We arrived at the following conclusions: (a) BR is a relatively effective first-line regimen in a real-world population of unfit patients without TP53 disruption, (b) ibrutinib provided longer disease control than BR in patients with advanced disease stage.

Published
2020

20. The Impact of Age on Survival in CLL Patients Receiving Ibrutinib as Initial Therapy

Author

Ujjani, C, Mato, A, Hill, BT, Allan, JN, Lansigan, F, Jacobs, R, Skarbnik, A, Tuncer, H, Pagel, J, Brander, D, Cheson, B, Barr, P, Roeker, LE, Pu, J, Shah, NN, Goy, A, Schuster, SJ, Lamanna, N, Sehgal, A, Tam, CS, Shadman, M, Ujjani, C, Mato, A, Hill, BT, Allan, JN, Lansigan, F, Jacobs, R, Skarbnik, A, Tuncer, H, Pagel, J, Brander, D, Cheson, B, Barr, P, Roeker, LE, Pu, J, Shah, NN, Goy, A, Schuster, SJ, Lamanna, N, Sehgal, A, Tam, CS, and Shadman, M

Abstract

INTRODUCTION: Recent randomized trials have demonstrated the efficacy of ibrutinib-based therapy in the treatment of patients with CLL. In Alliance A041202, a higher than expected number of unexplained deaths were reported with front-line ibrutinib in a patient population aged at least 65 years compared to ECOG 1912, which included patients up to 70 years of age. METHODS: Therefore, we conducted a retrospective analysis to investigate whether ibrutinib was associated with a greater mortality in older patients outside of a clinical trial setting. This multicenter analysis was performed by investigators at 20 academic and community practices. RESULTS: Amongst the 391 patients included, there was no correlation between age and response rate, PFS, or OS. However, there was a trend to higher rate of deaths in patients >65-years-old (8.7% vs 3.8%, p=0.097), with an increased number of early deaths (13 vs 4, p=0.3). CONCLUSION: These data suggest greater intolerance, and possibly mortality, with ibrutinib in an older population. Patients should be educated regarding the potential complications related to ibrutinib and symptoms of concern to report.

Published
2020

21. Efficacy of bendamustine and rituximab in unfit patients with previously untreated chronic lymphocytic leukemia. Indirect comparison with ibrutinib in a real-world setting. A GIMEMA-ERIC and US study

Author

Cuneo, A., Mato, A. R., Rigolin, G. M., Piciocchi, A., Gentile, Marino, Laurenti, Luca, Allan, J. N., Pagel, J. M., Brander, D. M., Hill, B. T., Winter, A., Lamanna, N., Tam, C. S., Jacobs, R., Lansigan, F., Barr, P. M., Shadman, M., Skarbnik, A. P., Pu, J. J., Sehgal, A. R., Schuster, S. J., Shah, N. N., Ujjani, C. S., Roeker, L., Orlandi, E. M., Billio, Atto, Trentin, L., Spacek, M., Marchetti, M., Tedeschi, Alessandra, Ilariucci, F., Gaidano, G., Doubek, M., Farina, L., Molica, Serena, Di Raimondo, F., Coscia, M., Mauro, F. R., de la Serna, J., Medina Perez, A., Ferrarini, I., Cimino, Giovanni, Cavallari, M., Cucci, R., Vignetti, M., Foa, Robin, Ghia, P., Gentile M., Laurenti L. (ORCID:0000-0002-8327-1396), Billio A., Tedeschi A., Molica S., Cimino G., Foa R., Cuneo, A., Mato, A. R., Rigolin, G. M., Piciocchi, A., Gentile, Marino, Laurenti, Luca, Allan, J. N., Pagel, J. M., Brander, D. M., Hill, B. T., Winter, A., Lamanna, N., Tam, C. S., Jacobs, R., Lansigan, F., Barr, P. M., Shadman, M., Skarbnik, A. P., Pu, J. J., Sehgal, A. R., Schuster, S. J., Shah, N. N., Ujjani, C. S., Roeker, L., Orlandi, E. M., Billio, Atto, Trentin, L., Spacek, M., Marchetti, M., Tedeschi, Alessandra, Ilariucci, F., Gaidano, G., Doubek, M., Farina, L., Molica, Serena, Di Raimondo, F., Coscia, M., Mauro, F. R., de la Serna, J., Medina Perez, A., Ferrarini, I., Cimino, Giovanni, Cavallari, M., Cucci, R., Vignetti, M., Foa, Robin, Ghia, P., Gentile M., Laurenti L. (ORCID:0000-0002-8327-1396), Billio A., Tedeschi A., Molica S., Cimino G., and Foa R.

Abstract

Limited information is available on the efficacy of front-line bendamustine and rituximab (BR) in chronic lymphocytic leukemia (CLL) with reduced renal function or coexisting conditions. We therefore analyzed a cohort of real-world patients and performed a matched adjusted indirect comparison with a cohort of patients treated with ibrutinib. One hundred and fifty-seven patients with creatinine clearance (CrCl) <70 mL/min and/or CIRS score >6 were treated with BR. The median age was 72 years; 69% of patients had ≥2 comorbidities and the median CrCl was 59.8 mL/min. 17.6% of patients carried TP53 disruption. The median progression-free survival (PFS) was 45 months; TP53 disruption was associated with a shorter PFS (P = 0.05). The overall survival (OS) at 12, 24, and 36 months was 96.2%, 90.1%, and 79.5%, respectively. TP53 disruption was associated with an increased risk of death (P = 0.01). Data on 162 patients ≥65 years treated with ibrutinib were analyzed and compared with 165 patients ≥65 years treated with BR. Factors predicting for a longer PFS at multivariable analysis in the total patient population treated with BR and ibrutinib were age (HR 1.06, 95% CI 1.02-1.10, P < 0.01) and treatment with ibrutinib (HR 0.55, 95% CI 0.33-0.93, P = 0.03). In a post hoc analysis of patients in advanced stage, a significant PFS advantage was observed in patient who had received ibrutinib (P = 0.03), who showed a trend for OS advantage (P = 0.08). We arrived at the following conclusions: (a) BR is a relatively effective first-line regimen in a real-world population of unfit patients without TP53 disruption, (b) ibrutinib provided longer disease control than BR in patients with advanced disease stage.

Published
2020

24. Bortezomib plus EPOCH is effective as frontline treatment in patients with plasmablastic lymphoma.

Author

Reagan J.L., Olszewski A.J., Fedele P., Bibas M., Grigoriadis G., Gilbertson M., Castillo J.J., Guerrero-Garcia T., Baldini F., Tchernonog E., Cartron G., Ninkovic S., Cwynarski K., Dierickx D., Tousseyn T., Lansigan F., Linnik Y., Mogollon R., Navarro J.-T., Reagan J.L., Olszewski A.J., Fedele P., Bibas M., Grigoriadis G., Gilbertson M., Castillo J.J., Guerrero-Garcia T., Baldini F., Tchernonog E., Cartron G., Ninkovic S., Cwynarski K., Dierickx D., Tousseyn T., Lansigan F., Linnik Y., Mogollon R., and Navarro J.-T.

Published
2019

25. PS1253 MAGNIFY: PHASE IIIB INTERIM ANALYSIS OF INDUCTION R2 FOLLOWED BY MAINTENANCE IN PATIENTS WITH RELAPSED/REFRACTORY INDOLENT NON-HODGKIN LYMPHOMA

Author

Rummel, M.J., primary, Andorsky, D.J., additional, Coleman, M., additional, Yacoub, A., additional, Melear, J.M., additional, Fanning, S.R., additional, Kolibaba, K.S., additional, Lansigan, F., additional, Reynolds, C., additional, Foon, K., additional, Li, J., additional, Llorente, M., additional, and Sharman, J., additional

Published
2019
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26. MAGNIFY PHASE IIIB INTERIM ANALYSIS: FIRST REPORT OF INDUCTION R2 FOLLOWED BY MAINTENANCE IN PATIENTS WITH RELAPSED/REFRACTORY MANTLE CELL LYMPHOMA

Author

Sharman, J., primary, Coleman, M., additional, Yacoub, A., additional, Melear, J., additional, Fanning, S., additional, Kolibaba, K., additional, Lansigan, F., additional, Reynolds, C., additional, Foon, K., additional, Li, J., additional, Llorente, M., additional, Rummel, M., additional, and Andorsky, D., additional

Published
2019
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27. A PHASE 2 STUDY TO ASSESS THE SAFETY AND EFFICACY OF UMBRALISIB IN PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) WHO ARE INTOLERANT TO PRIOR BTK OR PI3K DELTA INHIBITOR THERAPY

Author

Mato, A.R., primary, Schuster, S.J., additional, Lamanna, N., additional, Pagel, J.M., additional, Flinn, I.W., additional, Barrientos, J., additional, Reeves, J.A., additional, Cheson, B.D., additional, Barr, P.M., additional, Kambhampati, S., additional, Lansigan, F., additional, Pu, J.J., additional, Skarbnik, A., additional, Fonseca, G., additional, Dorsey, C., additional, LaRatta, N.M., additional, Weissbrot, H., additional, Svoboda, J., additional, Luning Prak, E.T., additional, Tsao, P., additional, Sitlinger, A., additional, Paskalis, D., additional, Sportelli, P., additional, Miskin, H.P., additional, Weiss, M.S., additional, and Brander, D.M., additional

Published
2019
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28. INTERIM ANALYSIS OF PHASE IIIB MAGNIFY STUDY OF INDUCTION R2 FOLLOWED BY MAINTENANCE IN PATIENTS WITH RELAPSED/REFRACTORY INDOLENT NON-HODGKIN LYMPHOMA

Author

Sharman, J., primary, Coleman, M., additional, Yacoub, A., additional, Melear, J., additional, Fanning, S., additional, Kolibaba, K., additional, Lansigan, F., additional, Reynolds, C., additional, Foon, K., additional, Li, J., additional, Llorente, M., additional, Rummel, M., additional, and Andorsky, D., additional

Published
2019
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29. Outcomes of front-line ibrutinib treated CLL patients excluded from landmark clinical trial

Author

Mato, AR, Roeker, LE, Allan, JN, Pagel, JM, Brander, DM, Hill, BT, Cheson, BD, Furman, RR, Lamanna, N, Tam, CS, Handunnetti, S, Jacobs, R, Lansigan, F, Bhavsar, E, Barr, PM, Shadman, M, Skarbnik, AP, Goy, A, Beach, DF, Svoboda, J, Pu, JJ, Sehgal, AR, Zent, CS, Tuncer, HH, Schuster, SJ, Pickens, PV, Shah, NN, Rhodes, J, Ujjani, CS, Nabhan, C, Mato, AR, Roeker, LE, Allan, JN, Pagel, JM, Brander, DM, Hill, BT, Cheson, BD, Furman, RR, Lamanna, N, Tam, CS, Handunnetti, S, Jacobs, R, Lansigan, F, Bhavsar, E, Barr, PM, Shadman, M, Skarbnik, AP, Goy, A, Beach, DF, Svoboda, J, Pu, JJ, Sehgal, AR, Zent, CS, Tuncer, HH, Schuster, SJ, Pickens, PV, Shah, NN, Rhodes, J, Ujjani, CS, and Nabhan, C

Abstract

Ibrutinib demonstrated superior response rates and survival for treatment-naïve chronic lymphocytic leukemia (CLL) patients in a pivotal study that excluded patients younger than 65 (<65) and/or with chromosome 17p13 deletion (del[17p13]). We examined outcomes and toxicities of CLL patients who would have been excluded from the pivotal study, specifically <65 and/or those with del[17p13]. This multicenter, retrospective cohort study examined CLL patients treated with front-line ibrutinib at 20 community and academic centers, categorizing them based on key inclusion criteria for the RESONATE-2 trial: <65 vs ≥65 and present vs absent del[17p13]. Of 391 included patients, 57% would have been excluded from the pivotal study. Forty-one percent of our cohort was <65, and 30% had del(17p13). Patients <65 were more likely to start 420 mg of ibrutinib daily; those who started at reduced doses had inferior PFS. The most common adverse events were arthralgias, fatigue, rash, bruising, and diarrhea. Twenty-four percent discontinued ibrutinib at 13.8 months median follow-up; toxicity was the most common reason for discontinuation, though progression and/or transformation accounted for a larger proportion of discontinuations in <65 and those with del(17p13). Response rates were similar for <65 and those with del(17p13). However, patients with del(17p13) had inferior PFS and OS. Ibrutinib in the front-line setting has extended beyond the population in which it was initially studied and approved. This study highlights and compares important differences in ibrutinib dosing, treatment interruptions, toxicities, reasons for discontinuation, and survival outcomes in two important patient populations not studied in RESONATE-2.

Published
2018

30. Ibrutinib combined with bendamustine and rituximab compared with placebo, bendamustine, and rituximab for previously treated chronic lymphocytic leukaemia or small lymphocytic lymphoma (HELIOS) : a randomised, double-blind, phase 3 study

Author

Chanan-Khan, Asher, Cramer, Paula, Demirkan, Fatih, Fraser, Graeme, Silva, Rodrigo Santucci, Grosicki, Sebastian, Pristupa, Aleksander, Janssens, Ann, Mayer, Jiri, Bartlett, Nancy L, Dilhuydy, Marie-Sarah, Pylypenko, Halyna, Loscertales, Javier, Avigdor, Abraham, Rule, Simon, Villa, Diego, Samoilova, Olga, Panagiotidis, Panagiots, Goy, Andre, Mato, Anthony, Pavlovsky, Miguel A, Karlsson, Claes, Mahler, Michelle, Salman, Mariya, Sun, Steven, Phelps, Charles, Balasubramanian, Sriram, Howes, Angela, Hallek, Michael, Assouline, S, Bence-Bruckler, I, Buckstein, R, Fraser, G, Larratt, L, Minuk, L, Villa, D, Angevine, A, Bartlett, N, Bixby, D, Caimi, P, Chanan-Khan, A, Craig, M, Forero-Torres, A, Ganguly, S, Goy, A, Heffner, L, Hermann, R, Lansigan, F, Leis, J, Letzer, J, Link, B, Liu, D, McCaul, K, McGuire, E, Skinner, W, Starodub, A, Stuart, R, Thirman, M, Tirumali, N, Yang, J, Janssens, A, Offner, F, Van den Neste, E, Van Hoof, A, Mayer, J, Novak, J, Trneny, M, Cartron, G, Dartigeas, C, Dilhuydy, M, Ghez, D, Haioun, C, Leblond, V, Salles, G, Balser, C, Cramer, P, Dreger, P, Durig, J, Eckart, M, Heinrich, B, Illmer, T, Jentsch-Ullrich, K, Pfreundschuh, M, Schetelig, J, Schlag, R, Soling, U, Stilgenbauer, S, Anagnostopoulos, A, Dimopoulos, A, Panagiotidis, P, Vrakidou, E, Bairey, O, Yehuda, D Ben, Braester, A, Fineman, R, Herishanu, Y, Nagler, A, Ruchlemer, R, Tadmor, T, Grosicki, S, Homenda, W, Jurczak, W, Pluta, A, Woszczyk, D, Espirito Santo, A, Luis, R, Raposo, J, Viveiros, C, Alexeeva, J, Dunaev, Y, Golubeva, M, Khuageva, N, Loginov, A, Lysenko, I, Osmanov, E, Pavlov, V, Pristupa, A, Proydakov, A, Rossiev, V, Samarina, I, Samoilova, O, Serduk, O, Shneider, T, Udovitsa, D, Voloshin, S, Gayoso, J, Gonzalez, M, Gonzalez Barca, E, Hernandez Rivas, J, Jargue, I, Loscertales, J, Karlsson, C, Sender, M, Aktan, M, Arslan, O, Demirkan, F, Ferhanoglu, B, Kaynar, L, Sayinalp, N, Vaural, F, Yagci, M, Dyagil, I, Kaplan, P, Masliak, Z, Oliynyk, H, Popovska, T, Pylypenko, H, Rekhtman, G, Dearden, C, Morley, N, Moss, P, Rule, S, Pavlovsky, M, Riveros, D, Santucci-Silva, R, Romeo, M, Scheliga, A, Salazar, L, Gomez, D, Ramirez, E, and Jung, C

Subjects
Male, Medizin, Gastroenterology, chemistry.chemical_compound, 0302 clinical medicine, Piperidines, immune system diseases, hemic and lymphatic diseases, Antineoplastic Combined Chemotherapy Protocols, Atrial Fibrillation, Bendamustine Hydrochloride, Aged, 80 and over, Anemia, Nausea, Middle Aged, 3. Good health, Fludarabine, Intention to Treat Analysis, Oncology, 030220 oncology & carcinogenesis, Ibrutinib, Retreatment, Disease Progression, Rituximab, Female, medicine.drug, Bendamustine, Adult, medicine.medical_specialty, Neutropenia, Hemorrhage, Disease-Free Survival, 03 medical and health sciences, Double-Blind Method, Internal medicine, medicine, Humans, Aged, Performance status, business.industry, Adenine, medicine.disease, Interim analysis, Leukemia, Lymphocytic, Chronic, B-Cell, Thrombocytopenia, Surgery, Regimen, Pyrimidines, chemistry, Pyrazoles, Mantle cell lymphoma, business, 030215 immunology
Abstract

Most patients with chronic lymphocytic leukaemia or small lymphocytic lymphoma relapse after initial therapy. Bendamustine plus rituximab is often used in the relapsed or refractory setting. We assessed the efficacy and safety of adding ibrutinib, an oral covalent inhibitor of Bruton's tyrosine kinase (BTK), to bendamustine plus rituximab in patients with previously treated chronic lymphocytic leukaemia or small lymphocytic lymphoma.The HELIOS trial was an international, double-blind, placebo-controlled, phase 3 study in adult patients (≥18 years of age) who had active chronic lymphocytic leukaemia or small lymphocytic lymphoma with measurable lymph node disease (1·5 cm) by CT scan, and had relapsed or refractory disease following one or more previous lines of systemic therapy consisting of at least two cycles of a chemotherapy-containing regimen, an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, and adequate bone marrow, liver, and kidney function. Patients with del(17p) were excluded because of known poor response to bendamustine plus rituximab. Patients who had received previous treatment with ibrutinib or other BTK inhibitors, refractory disease or relapse within 24 months with a previous bendamustine-containing regimen, or haemopoietic stem-cell transplant were also excluded. Patients were randomly assigned (1:1) by a web-based system to receive bendamustine plus rituximab given in cycles of 4 weeks' duration (bendamustine: 70 mg/m(2) intravenously on days 2-3 in cycle 1, and days 1-2 in cycles 2-6; rituximab: 375 mg/m(2) on day 1 of cycle 1, and 500 mg/m(2) on day 1 of cycles 2-6 for a maximum of six cycles) with either ibrutinib (420 mg daily orally) or placebo until disease progression or unacceptable toxicity. Patients were stratified according to whether they were refractory to purine analogues and by number of previous lines of therapy. The primary endpoint was independent review committee (IRC)-assessed progression-free survival. Crossover to ibrutinib was permitted for patients in the placebo group with IRC-confirmed disease progression. Analysis was by intention-to-treat and is continuing for further long-term follow-up. The trial is registered with ClinicalTrials.gov, number NCT01611090.Between Sept 19, 2012, and Jan 21, 2014, 578 eligible patients were randomly assigned to ibrutinib or placebo in combination with bendamustine plus rituximab (289 in each group). The primary endpoint was met at the preplanned interim analysis (March 10, 2015). At a median follow-up of 17 months (IQR 13·7-20·7), progression-free survival was significantly improved in the ibrutinib group compared with the placebo group (not reached in the ibrutinib group (95% CI not evaluable) vs 13·3 months (11·3-13·9) in the placebo group (hazard ratio [HR] 0·203, 95% CI 0·150-0·276; p0·0001). IRC-assessed progression-free survival at 18 months was 79% (95% CI 73-83) in the ibrutinib group and 24% (18-31) in the placebo group (HR 0·203, 95% CI 0·150-0·276; p0·0001). The most frequent all-grade adverse events were neutropenia and nausea. 222 (77%) of 287 patients in the ibrutinib group and 212 (74%) of 287 patients in the placebo group reported grade 3-4 events; the most common grade 3-4 adverse events in both groups were neutropenia (154 [54%] in the ibrutinib group vs 145 [51%] in the placebo group) and thrombocytopenia (43 [15%] in each group). A safety profile similar to that previously reported with ibrutinib and bendamustine plus rituximab individually was noted.In patients eligible for bendamustine plus rituximab, the addition of ibrutinib to this regimen results in significant improvements in outcome with no new safety signals identified from the combination and a manageable safety profile.Janssen ResearchDevelopment.

Published
2016

31. UBLITUXIMAB AND IBRUTINIB FOR PREVIOUSLY TREATED GENETICALLY HIGH-RISK CHRONIC LYMPHOCYTIC LEUKEMIA: RESULTS OF THE GENUINE PHASE 3 STUDY

Author

Sharman, J.P., primary, Brander, D.M., additional, Mato, A., additional, Kambhampati, S., additional, Burke, J.M., additional, Lansigan, F., additional, Schreeder, M.T., additional, Lunin, S.D., additional, Ghosh, N., additional, Zweibach, A., additional, Shtivelband, M.I., additional, Travis, P.M., additional, Chandler, J., additional, Kolibaba, K.S., additional, Sporteli, P., additional, Miskin, H.P., additional, Weiss, M.S., additional, and Flinn, I.W., additional

Published
2017
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32. PHASE IIIB STUDY OF LENALIDOMIDE PLUS RITUXIMAB FOLLOWED BY MAINTENANCE IN RELAPSED OR REFRACTORY NHL: ANALYSIS OF MARGINAL ZONE LYMPHOMA

Author

Coleman, M., primary, Andorsky, D.J., additional, Yacoub, A., additional, Melear, J.M., additional, Kolibaba, K.S., additional, Brooks, H.D., additional, Bitran, J.D., additional, Fanning, S.R., additional, Lansigan, F., additional, Ricker, J.L., additional, Foon, K.A., additional, Llorente, M., additional, Li, J., additional, and Sharman, J.P., additional

Published
2017
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39. Humans transforming the global water system

Author

Vörösmarty, C., primary, Lettenmaier, D., additional, Leveque, C., additional, Meybeck, M., additional, Pahl-Wostl, C., additional, Alcamo, J., additional, Cosgrove, W., additional, Grassl, H., additional, Hoff, H., additional, Kabat, P., additional, Lansigan, F., additional, Lawford, R., additional, and Naiman, R., additional

Published
2004
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42. Linking Corn Production, Climate Information and Farm-Level Decision-Making: A Case Study in Isabela, Philippines.

Author

Sivakumar, Mannava V. K., Hansen, James, de los Santos, W. L., Lansigan, F. P., and Hansen, J.

Abstract

Corn is the second most important crop in the Philippines in terms of total area planted and overall value next only to rice. Yellow corn is the most important corn type in the Philippines, and is primarily used as feed especially for poultry and swine. In 2003, more than 844 885 ha of agricultural land in the Philippines were planted to yellow corn. [ABSTRACT FROM AUTHOR]

Published
2007
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43. Delivering Climate Forecast Products to Farmers: Ex Post Assessment of Impacts of Climate Information on Corn Production Systems in Isabela, Philippines.

Author

Sivakumar, Mannava V. K., Hansen, James, Lansigan, F. P., de los Santos, W. L., and Hansen, J.

Abstract

Corn production is the principal source of family income for about 24 million Filipinos. Isabela Province, located in one of the most depressed regions in northern Philippines, is considered the top corn-producing province in the country contributing 17% or 536 353 tons of the total yellow corn production in the country. Corn is grown rainfed in Isabela. Monocropping of corn is predominantly practiced in Isabela and there are two cropping seasons per year — wet season cropping from May to August and dry season cropping from November to February. In 2003, a total of 146 965 hectares were planted to yellow corn in the province. In the same year, average yield of yellow corn was 3.65 tons per hectare (t ha−1) which was comparatively higher than the national yellow corn yield average of 3.03 t ha−1. Most of the corn type being produced in the province is yellow corn which comprised 95% of the total corn produced in the province (Lansigan et al. 2001). Yellow corn is primarily used as animal feed ingredient especially for poultry and swine. [ABSTRACT FROM AUTHOR]

Published
2007
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44. Current and emerging treatment strategies for cutaneous T-cell lymphoma.

Author

Lansigan F and Foss FM

Abstract

Cutaneous T-cell lymphomas (CTCLs) are a rare group of mature T-cell lymphomas presenting primarily in the skin. The most common subtypes of CTCL are mycosis fungoides and its leukaemic variant Sézary's syndrome. Patients with early-stage disease frequently have an indolent clinical course; however, those with advanced stages have a shortened survival. For the treating physician, the question of how to choose a particular therapy in the management of CTCL is important. These diseases span the disciplines of dermatology, medical oncology and radiation oncology. Other than an allogeneic stem cell transplant, there are no curative therapies for this disease. Hence, many treatment modalities need to be offered to the patient over the course of their life. An accepted treatment approach has been to delay traditional chemotherapy, which can cause excessive toxicity without durable benefit. More conservative treatment strategies in the initial management of CTCL have led to the development of newer biological and targeted therapies. These therapies include biological immune enhancers such as interferon alpha and extracorporeal photopheresis that exert their effect by stimulating an immune response to the tumour cells. Retinoids such as bexarotene have been shown to be effective and well tolerated with predictable adverse effects. The fusion toxin denileukin diftitox targets the interleukin-2 receptor expressed on malignant T cells. Histone deacetylase inhibitors such as vorinostat and romidepsin (depsipeptide) may reverse the epigenetic states associated with cancer. Forodesine is a novel inhibitor of purine nucleoside phosphorylase and leads to apoptosis of malignant T cells. Pralatrexate is a novel targeted antifolate that targets the reduced folate carrier in cancer cells. Lastly, systemic chemotherapy including transplantation is used when rapid disease control is needed or if all other biological therapies have failed. As response rates to most of the biological agents used to treat CTCL are 25-30%, it is also reasonable to consider clinical trials with novel agents if one or two front-line therapies have failed, especially before considering chemotherapy. CTCL is largely an incurable disease with significant morbidity and more active agents are needed. [ABSTRACT FROM AUTHOR]

Published
2010
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48. Optimal weeding treatments in upland rice: A crop competition experiment

Author

Legaspi, B. A. C., Medina, C. P., Alagos, J. C., Magcale-Macandog, D. B., and Lansigan, F. P.

Abstract

A field experiment was performed to determine the effects of different times and frequencies of handweeding on grain yields in upland rice. Five weeding treatments were done. These treatments consisted of single weedings at 20 and 35 days after emergence (d.a.e.) and double weedings at 10 and 15 d.a.e., 20 and 35 d.a.e. and 30 and 45 d.a.e. Two controls were made: a weed-free control where weeds were continuously removed and a weedy control where no handweeding was done. Aboveground destructive harvests on the controls were used to determine dry matter partitioning. These were performed at 10, 30, 50, 70 and 90 d.a.e. and at harvest. Rice and weed heights were measured for the controls and all treatments. Grain yields were compared and analyzed statistically. Absence of weed control produced only 50 kg/ha of grain. Single weeding increased yield to about 2000 kg/ ha and double weeding to about 2500 kg/ha. However, no significant differences were found between treatments of the same weeding frequency. Complete weed control produced 3000 kg/ha of grain. During grain formation, stem weight of weed-free rice declined by 24% as compared to 74% in weedy rice.

Published
1989
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