A Phase II trial of Belinostat (PXD101) in patients with relapsed or refractory peripheral or cutaneous T-cell lymphoma

Francine Foss; Ranjana Advani; Madeleine Duvic; Kenneth B. Hymes; Tanin Intragumtornchai; Arnuparp Lekhakula; Ofer Shpilberg; Adam Lerner; Robert J. Belt; Eric D. Jacobsen; Guy Laurent; Dina Ben-Yehuda; Marie Beylot-Barry; Uwe Hillen; Poul Knoblauch; Gajanan Bhat; Shanta Chawla; Lee F. Allen; Brad Pohlman

doi:10.1111/bjh.13222

A Phase II trial of Belinostat (PXD101) in patients with relapsed or refractory peripheral or cutaneous T-cell lymphoma

Francine Foss^*, Ranjana Advani, Madeleine Duvic, Kenneth B. Hymes, Tanin Intragumtornchai, Arnuparp Lekhakula, Ofer Shpilberg, Adam Lerner, Robert J. Belt, Eric D. Jacobsen, Guy Laurent, Dina Ben-Yehuda, Marie Beylot-Barry, Uwe Hillen, Poul Knoblauch, Gajanan Bhat, Shanta Chawla, Lee F. Allen, Brad Pohlman

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

167 Scopus citations

Abstract

Belinostat is a pan-histone deacetylase inhibitor with antitumour and anti-angiogenic properties. An open label, multicentre study was conducted in patients with peripheral T-cell lymphoma (PTCL) or cutaneous T-cell lymphoma (CTCL) who failed ≥1 prior systemic therapy and were treated with belinostat (1000mg/m² intravenously ×5d of a 21-d cycle). The primary endpoint was objective response rate (ORR). Patients with PTCL (n=24) had received a median of three prior systemic therapies (range 1-9) and 40% had stage IV disease. Patients with CTCL (n=29) had received a median of one prior skin-directed therapy (range 0-4) and four prior systemic therapies (range 1-9); 55% had stage IV disease. The ORRs were 25% (PTCL) and 14% (CTCL). Treatment-related adverse events occurred in 77% of patients; nausea (43%), vomiting (21%), infusion site pain (13%) and dizziness (11%) had the highest incidence. Treatment-related serious adverse events were Grade 5 ventricular fibrillation; Grade 4 thrombocytopenia; Grade 3 peripheral oedema, apraxia, paralytic ileus and pneumonitis; and Grade 2 jugular vein thrombosis. Belinostat monotherapy was well tolerated and efficacious in patients with recurrent/refractory PTCL and CTCL. This trial was registered at www.clinicaltrials.gov as NCT00274651.

Original language	English
Pages (from-to)	811-819
Number of pages	9
Journal	British Journal of Haematology
Volume	168
Issue number	6
DOIs	https://doi.org/10.1111/bjh.13222
State	Published - 1 Mar 2015
Externally published	Yes

Bibliographical note

Publisher Copyright:
© 2014 John Wiley & Sons Ltd.

Keywords

Belinostat
Histone deacetylase inhibitors
Mycosis fungoides
Peripheral T cell Lymphoma
T cell lymphoma

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1111/bjh.13222

Cite this

Foss, F., Advani, R., Duvic, M., Hymes, K. B., Intragumtornchai, T., Lekhakula, A., Shpilberg, O., Lerner, A., Belt, R. J., Jacobsen, E. D., Laurent, G., Ben-Yehuda, D., Beylot-Barry, M., Hillen, U., Knoblauch, P., Bhat, G., Chawla, S., Allen, L. F., & Pohlman, B. (2015). A Phase II trial of Belinostat (PXD101) in patients with relapsed or refractory peripheral or cutaneous T-cell lymphoma. British Journal of Haematology, 168(6), 811-819. https://doi.org/10.1111/bjh.13222

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title = "A Phase II trial of Belinostat (PXD101) in patients with relapsed or refractory peripheral or cutaneous T-cell lymphoma",

abstract = "Belinostat is a pan-histone deacetylase inhibitor with antitumour and anti-angiogenic properties. An open label, multicentre study was conducted in patients with peripheral T-cell lymphoma (PTCL) or cutaneous T-cell lymphoma (CTCL) who failed ≥1 prior systemic therapy and were treated with belinostat (1000mg/m2 intravenously ×5d of a 21-d cycle). The primary endpoint was objective response rate (ORR). Patients with PTCL (n=24) had received a median of three prior systemic therapies (range 1-9) and 40% had stage IV disease. Patients with CTCL (n=29) had received a median of one prior skin-directed therapy (range 0-4) and four prior systemic therapies (range 1-9); 55% had stage IV disease. The ORRs were 25% (PTCL) and 14% (CTCL). Treatment-related adverse events occurred in 77% of patients; nausea (43%), vomiting (21%), infusion site pain (13%) and dizziness (11%) had the highest incidence. Treatment-related serious adverse events were Grade 5 ventricular fibrillation; Grade 4 thrombocytopenia; Grade 3 peripheral oedema, apraxia, paralytic ileus and pneumonitis; and Grade 2 jugular vein thrombosis. Belinostat monotherapy was well tolerated and efficacious in patients with recurrent/refractory PTCL and CTCL. This trial was registered at www.clinicaltrials.gov as NCT00274651.",

keywords = "Belinostat, Histone deacetylase inhibitors, Mycosis fungoides, Peripheral T cell Lymphoma, T cell lymphoma",

author = "Francine Foss and Ranjana Advani and Madeleine Duvic and Hymes, {Kenneth B.} and Tanin Intragumtornchai and Arnuparp Lekhakula and Ofer Shpilberg and Adam Lerner and Belt, {Robert J.} and Jacobsen, {Eric D.} and Guy Laurent and Dina Ben-Yehuda and Marie Beylot-Barry and Uwe Hillen and Poul Knoblauch and Gajanan Bhat and Shanta Chawla and Allen, {Lee F.} and Brad Pohlman",

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month = mar,

day = "1",

doi = "10.1111/bjh.13222",

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Foss, F, Advani, R, Duvic, M, Hymes, KB, Intragumtornchai, T, Lekhakula, A, Shpilberg, O, Lerner, A, Belt, RJ, Jacobsen, ED, Laurent, G, Ben-Yehuda, D, Beylot-Barry, M, Hillen, U, Knoblauch, P, Bhat, G, Chawla, S, Allen, LF & Pohlman, B 2015, 'A Phase II trial of Belinostat (PXD101) in patients with relapsed or refractory peripheral or cutaneous T-cell lymphoma', British Journal of Haematology, vol. 168, no. 6, pp. 811-819. https://doi.org/10.1111/bjh.13222

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T1 - A Phase II trial of Belinostat (PXD101) in patients with relapsed or refractory peripheral or cutaneous T-cell lymphoma

AU - Foss, Francine

AU - Advani, Ranjana

AU - Duvic, Madeleine

AU - Hymes, Kenneth B.

AU - Intragumtornchai, Tanin

AU - Lekhakula, Arnuparp

AU - Shpilberg, Ofer

AU - Lerner, Adam

AU - Belt, Robert J.

AU - Jacobsen, Eric D.

AU - Laurent, Guy

AU - Ben-Yehuda, Dina

AU - Beylot-Barry, Marie

AU - Hillen, Uwe

AU - Knoblauch, Poul

AU - Bhat, Gajanan

AU - Chawla, Shanta

AU - Allen, Lee F.

AU - Pohlman, Brad

PY - 2015/3/1

Y1 - 2015/3/1

N2 - Belinostat is a pan-histone deacetylase inhibitor with antitumour and anti-angiogenic properties. An open label, multicentre study was conducted in patients with peripheral T-cell lymphoma (PTCL) or cutaneous T-cell lymphoma (CTCL) who failed ≥1 prior systemic therapy and were treated with belinostat (1000mg/m2 intravenously ×5d of a 21-d cycle). The primary endpoint was objective response rate (ORR). Patients with PTCL (n=24) had received a median of three prior systemic therapies (range 1-9) and 40% had stage IV disease. Patients with CTCL (n=29) had received a median of one prior skin-directed therapy (range 0-4) and four prior systemic therapies (range 1-9); 55% had stage IV disease. The ORRs were 25% (PTCL) and 14% (CTCL). Treatment-related adverse events occurred in 77% of patients; nausea (43%), vomiting (21%), infusion site pain (13%) and dizziness (11%) had the highest incidence. Treatment-related serious adverse events were Grade 5 ventricular fibrillation; Grade 4 thrombocytopenia; Grade 3 peripheral oedema, apraxia, paralytic ileus and pneumonitis; and Grade 2 jugular vein thrombosis. Belinostat monotherapy was well tolerated and efficacious in patients with recurrent/refractory PTCL and CTCL. This trial was registered at www.clinicaltrials.gov as NCT00274651.

AB - Belinostat is a pan-histone deacetylase inhibitor with antitumour and anti-angiogenic properties. An open label, multicentre study was conducted in patients with peripheral T-cell lymphoma (PTCL) or cutaneous T-cell lymphoma (CTCL) who failed ≥1 prior systemic therapy and were treated with belinostat (1000mg/m2 intravenously ×5d of a 21-d cycle). The primary endpoint was objective response rate (ORR). Patients with PTCL (n=24) had received a median of three prior systemic therapies (range 1-9) and 40% had stage IV disease. Patients with CTCL (n=29) had received a median of one prior skin-directed therapy (range 0-4) and four prior systemic therapies (range 1-9); 55% had stage IV disease. The ORRs were 25% (PTCL) and 14% (CTCL). Treatment-related adverse events occurred in 77% of patients; nausea (43%), vomiting (21%), infusion site pain (13%) and dizziness (11%) had the highest incidence. Treatment-related serious adverse events were Grade 5 ventricular fibrillation; Grade 4 thrombocytopenia; Grade 3 peripheral oedema, apraxia, paralytic ileus and pneumonitis; and Grade 2 jugular vein thrombosis. Belinostat monotherapy was well tolerated and efficacious in patients with recurrent/refractory PTCL and CTCL. This trial was registered at www.clinicaltrials.gov as NCT00274651.

KW - Belinostat

KW - Histone deacetylase inhibitors

KW - Mycosis fungoides

KW - Peripheral T cell Lymphoma

KW - T cell lymphoma

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ER -

A Phase II trial of Belinostat (PXD101) in patients with relapsed or refractory peripheral or cutaneous T-cell lymphoma

Abstract

Bibliographical note

Keywords

UN SDGs

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