Difference between revisions of "Peripheral T-cell lymphoma"

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====Chemotherapy====
 
====Chemotherapy====
−
*Alisertib 30 mg PO BID on days 1 to 7
+
*[[Alisertib (MLN8237)]] 30 mg PO BID on days 1 to 7
  
 
'''21-day cycle for up to 3 cycles'''
 
'''21-day cycle for up to 3 cycles'''

Revision as of 16:18, 11 March 2019

30 regimens on this page
37 variants on this page

Note: some subtypes of PTCL have been moved to dedicated pages:


Guidelines

ESMO

Older

NCCN

Untreated, randomized data

BV-CHP

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BV-CHP: Brentuximab Vedotin, Cyclophosphamide, Hydroxydaunorubicin (Doxorubicin), Prednisone
A+CHP: Adcetris (Brentuximab vedotin), Cyclophosphamide, Hydroxydaunorubicin (Doxorubicin), Prednisone

Regimen

FDA-recommended dose
Study Evidence Comparator Efficacy
Horwitz et al. 2018 (ECHELON-2) Phase III (E) CHOP Seems to have superior OS

Chemotherapy

21-day cycle for 6 to 8 cycles

References

  1. ECHELON-2: Horwitz S, O'Connor OA, Pro B, Illidge T, Fanale M, Advani R, Bartlett NL, Christensen JH, Morschhauser F, Domingo-Domenech E, Rossi G, Kim WS, Feldman T, Lennard A, Belada D, Illés Á, Tobinai K, Tsukasaki K, Yeh SP, Shustov A, Hüttmann A, Savage KJ, Yuen S, Iyer S, Zinzani PL, Hua Z, Little M, Rao S, Woolery J, Manley T, Trümper L; ECHELON-2 Study Group. Brentuximab vedotin with chemotherapy for CD30-positive peripheral T-cell lymphoma (ECHELON-2): a global, double-blind, randomised, phase 3 trial. Lancet. 2018 Dec 3. [Epub ahead of print] link to original article contains protocol PubMed

CHOP

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CHOP: Cyclophosphamide, Hydroxydaunorubicin (Doxorubicin), Oncovin (Vincristine), Prednisone

Variant #1, 6 cycles

Study Evidence Comparator Efficacy
Reimer et al. 2004 Non-randomized
Li et al. 2017 Phase III (C) GDPT Inferior OS

Note: the abstract of Reimer et al. 2004 does not have dosing details, and the original article could not be located.

Chemotherapy

21-day cycle for 6 cycles

Variant #2, 8 cycles

Study Evidence Comparator Efficacy
Simon et al. 2010 (GOELAMS LTP95) Phase III (C) VIP-rABVD Seems not superior

Chemotherapy

21-day cycle for 8 cycles

Subsequent treatment

  • Patients with initial bulky disease (diameter at least 5 cm): IFRT x 40 Gy

References

  1. Reimer P, Schertlin T, Rüdiger T, Geissinger E, Roth S, Kunzmann V, Weissinger F, Nerl C, Schmitz N, Müller-Hermelink HK, Wilhelm M. Myeloablative radiochemotherapy followed by autologous peripheral blood stem cell transplantation as first-line therapy in peripheral T-cell lymphomas: first results of a prospective multicenter study. Hematol J. 2004;5(4):304-11. does not contain protocol PubMed
    1. Update: Reimer P, Rüdiger T, Geissinger E, Weissinger F, Nerl C, Schmitz N, Engert A, Einsele H, Müller-Hermelink HK, Wilhelm M. Autologous stem-cell transplantation as first-line therapy in peripheral T-cell lymphomas: results of a prospective multicenter study. J Clin Oncol. 2009 Jan 1;27(1):106-13. Epub 2008 Nov 24. link to original article PubMed
  2. GOELAMS-LTP95: Simon A, Peoch M, Casassus P, Deconinck E, Colombat P, Desablens B, Tournilhac O, Eghbali H, Foussard C, Jaubert J, Vilque JP, Rossi JF, Lucas V, Delwail V, Thyss A, Maloisel F, Milpied N, le Gouill S, Lamy T, Gressin R. Upfront VIP-reinforced-ABVD (VIP-rABVD) is not superior to CHOP/21 in newly diagnosed peripheral T cell lymphoma: results of the randomized phase III trial GOELAMS-LTP95. Br J Haematol. 2010 Oct;151(2):159-66. Epub 2010 Aug 25. link to original article contains verified protocol PubMed
  3. Meta-analysis: Abouyabis AN, Shenoy PJ, Sinha R, Flowers CR, Lechowicz MJ. A systematic review and meta-analysis of front-line anthracycline-based chemotherapy regimens for peripheral T-cell lymphoma. ISRN Hematol. 2011;2011:623924. Epub 2011 Jun 16. link to original article link to PMC article PubMed
  4. Li L, Duan W, Zhang L, Li X, Fu X, Wang X, Wu J, Sun Z, Zhang X, Chang Y, Nan F, Yan J, Li Z, Young KH, Zhang M. The efficacy and safety of gemcitabine, cisplatin, prednisone, thalidomide versus CHOP in patients with newly diagnosed peripheral T-cell lymphoma with analysis of biomarkers. Br J Haematol. 2017 Sep;178(5):772-780. Epub 2017 Jun 9. link to original article contains verified protocol PubMed

CMED

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CMED: Cyclophosphamide, Methotrexate, Etoposide, Dexamethasone

Regimen

Study Evidence Comparator Efficacy
Avilés et al. 2008 Phase III (E) CHOP Superior OS

Chemotherapy

Supportive medications

14-day cycle for 6 cycles

References

  1. Avilés A, Castañeda C, Neri N, Cleto S, Talavera A, González M, Huerta-Guzmán J, Nambo MJ. Results of a phase III clinical trial: CHOP versus CMED in peripheral T-cell lymphoma unspecified. Med Oncol. 2008;25(3):360-4. Epub 2008 Feb 5. link to original article contains verified protocol PubMed

GDPT

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GDPT: Gemcitabine, DDP (Cisplatin), Prednisone, Thalidomide

Regimen

Study Evidence Comparator Efficacy
Li et al. 2017 Phase III (E) CHOP Superior OS

Chemotherapy

Supportive medications

21-day cycle for 6 cycles

References

  1. Li L, Duan W, Zhang L, Li X, Fu X, Wang X, Wu J, Sun Z, Zhang X, Chang Y, Nan F, Yan J, Li Z, Young KH, Zhang M. The efficacy and safety of gemcitabine, cisplatin, prednisone, thalidomide versus CHOP in patients with newly diagnosed peripheral T-cell lymphoma with analysis of biomarkers. Br J Haematol. 2017 Sep;178(5):772-780. Epub 2017 Jun 9. link to original article contains verified protocol PubMed

Untreated, non-randomized or retrospective data

CHOEP-14

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CHOEP-14: Cyclophosphamide, Hydroxydaunorubicin (Doxorubicin), Oncovin (Vincristine), Etoposide, Prednisone every 14 days

Regimen

Study Evidence
d'Amore et al. 2012 (NLG-T-01) Phase II

Chemotherapy

14-day cycle for 6 cycles

Subsequent treatment

  • If patients in PR or CR after three cycles, stem cells are mobilized off of cycles 5 and 6, followed by BEAC or BEAM, then auto HSCT

References

  1. NLG-T-01: d'Amore F, Relander T, Lauritzsen GF, Jantunen E, Hagberg H, Anderson H, Holte H, Österborg A, Merup M, Brown P, Kuittinen O, Erlanson M, Østenstad B, Fagerli UM, Gadeberg OV, Sundström C, Delabie J, Ralfkiaer E, Vornanen M, Toldbod HE. Up-front autologous stem-cell transplantation in peripheral T-cell lymphoma: NLG-T-01. J Clin Oncol. 2012 Sep 1;30(25):3093-9. Epub 2012 Jul 30. link to original article contains verified protocol PubMed

CHOP & Everolimus

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CHOP & Everolimus: Cyclophosphamide, Hydroxydaunorubicin (Doxorubicin), Oncovin (Vincristine), Prednisone, Everolimus

Regimen

Study Evidence Efficacy
Kim et al. 2016 Phase II ORR: 90%

Chemotherapy

21-day cycle for up to 6 cycles

References

  1. Kim SJ, Shin DY, Kim JS, Yoon DH, Lee WS, Lee H, Do YR, Kang HJ, Eom HS, Ko YH, Lee SH, Yoo HY, Hong M, Suh C, Kim WS. A phase II study of everolimus (RAD001), an mTOR inhibitor plus CHOP for newly diagnosed peripheral T-cell lymphomas. Ann Oncol. 2016 Apr;27(4):712-8. link to original article contains verified protocol PubMed

CHOP-AL

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CHOP-AL: Cyclophosphamide, Hydroxydaunorubicin (Doxorubicin), Oncovin (Vincristine), Prednisone, ALemtuzumab
CHOP-C: Cyclophosphamide, Hydroxydaunorubicin (Doxorubicin), Oncovin (Vincristine), Prednisone, Campath (Alemtuzumab)

Variant #1, 2 cycles

Study Evidence
Corradini et al. 2014 Phase II

These are the details for "Clin A" which was the regimen used for patients younger than 60. Note: this is a component of a sequential treatment protocol; to our knowledge there are no references to support using it as a stand-alone treatment.

Chemotherapy

21-day cycle for 2 cycles

Subsequent treatment

Variant #2, 8 cycles

Study Evidence
Gallamini et al. 2007 Phase II

Note: the paper reports using the CHOP dosing as specified by Fisher et al. 1993; however, note that the cycle length here is 28 days.

Chemotherapy

Supportive medications

28-day cycle for 8 cycles

References

  1. Gallamini A, Zaja F, Patti C, Billio A, Specchia MR, Tucci A, Levis A, Manna A, Secondo V, Rigacci L, Pinto A, Iannitto E, Zoli V, Torchio P, Pileri S, Tarella C. Alemtuzumab (Campath-1H) and CHOP chemotherapy as first-line treatment of peripheral T-cell lymphoma: results of a GITIL (Gruppo Italiano Terapie Innovative nei Linfomi) prospective multicenter trial. Blood. 2007 Oct 1;110(7):2316-23. Epub 2007 Jun 20. link to original article contains partial protocol PubMed
  2. Corradini P, Vitolo U, Rambaldi A, Miceli R, Patriarca F, Gallamini A, Olivieri A, Benedetti F, Todeschini G, Rossi G, Salvi F, Bruno B, Baldini L, Ferreri A, Patti C, Tarella C, Pileri S, Dodero A. Intensified chemo-immunotherapy with or without stem cell transplantation in newly diagnosed patients with peripheral T-cell lymphoma. Leukemia. 2014 Sep;28(9):1885-91. Epub 2014 Feb 20. link to original article contains verified protocol PubMed

DA-EPOCH

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DA-EPOCH: Dose Adjusted Etoposide, Prednisone, Oncovin (Vincristine), Cyclophosphamide, Hydroxydaunorubicin (Doxorubicin)

Regimen

Study Evidence Efficacy
Maeda et al. 2017 (West-JHOG PTCL0707) Phase II ORR: 78% (95% CI 62-89)

Note: the authors state that they followed the Wilson et al. 2002 protocol, but there are some differences, in particular 1) it isn't clear whether prednisone is given once or twice per day; and 2) dose adjustments below level 1 are different based on age.

Chemotherapy

Supportive medications

21-day cycle for 6 to 8 cycles

Dose-adjustments

  • Start cycle 1 as described above.
  • Obtain CBCs twice per week for nadir measurements.
  • If nadir ANC greater than 500/uL, increase etoposide, doxorubicin, and cyclophosphamide by 20% compared to previous cycle.
  • If nadir ANC less than 500/uL on 1 or 2 measurements, use same doses as last cycle.
  • If nadir ANC less than 500/uL on at least 3 measurements, decrease etoposide, doxorubicin, and cyclophosphamide by 20% compared to previous cycle.
  • And/or if nadir platelet count less than 25 x 109/L on at least 1 measurement, decrease etoposide, doxorubicin, and cyclophosphamide by 20% compared to previous cycle.
  • Patients younger than 70: Dose adjustments below the cycle 1 starting dose only apply to cyclophosphamide. That is, the lowest etoposide and doxorubicin would be dosed is at the original cycle 1 dose.
  • Patients 70 and older: Dose adjustments below the cycle 1 starting dose apply to all drugs
  • (Presumed, based on Wilson et al. 2002): Can start new cycle every 21 days if ANC greater than 1000/uL and platelets greater than 100 x 109/L. If counts are below those levels, check daily CBC and continue growth factor support until counts are adequate and next cycle can start.

References

  1. Maeda Y, Nishimori H, Yoshida I, Hiramatsu Y, Uno M, Masaki Y, Sunami K, Masunari T, Nawa Y, Yamane H, Gomyo H, Takahashi T, Yano T, Matsuo K, Ohshima K, Nakamura S, Yoshino T, Tanimoto M. Dose-adjusted EPOCH chemotherapy for untreated peripheral T-cell lymphomas: a multicenter phase II trial of West-JHOG PTCL0707. Haematologica. 2017 Dec;102(12):2097-2103. Epub 2017 Sep 29. link to original article contains verified protocol PubMed

DD-CHOP

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DD-CHOP: Denileukin, Diftitox, Cyclophosphamide, Hydroxydaunorubicin (Doxorubicin), Oncovin (Vincristine), Prednisone

Regimen

Study Evidence Efficacy
Foss et al. 2013 (CONCEPT) Phase II ORR: 65%

Chemotherapy

Supportive medications

21-day cycle for 6 to 8 cycles

References

  1. Foss FM, Sjak-Shie N, Goy A, Jacobsen E, Advani R, Smith MR, Komrokji R, Pendergrass K, Bolejack V. A multicenter phase II trial to determine the safety and efficacy of combination therapy with denileukin diftitox and cyclophosphamide, doxorubicin, vincristine and prednisone in untreated peripheral T-cell lymphoma: the CONCEPT study. Leuk Lymphoma. 2013 Jul;54(7):1373-9. Epub 2013 Jan 29. link to original article contains verified protocol PubMed

HyperCHidam

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HyperCHidam: Hyperfractionated Cyclophosphamide, Hiigh-dose ara-c (Cytarabine) & methotrexate

Regimen

Study Evidence
Corradini et al. 2014 Phase II

These are the details for "Clin A" which was the regimen used for patients younger than 60. Note: this is a component of a sequential treatment protocol; to our knowledge there are no references to support using it as a stand-alone treatment.

Preceding treatment

Chemotherapy

Supportive medications

Duration not specified for 2 cycles

Subsequent treatment

References

  1. Corradini P, Vitolo U, Rambaldi A, Miceli R, Patriarca F, Gallamini A, Olivieri A, Benedetti F, Todeschini G, Rossi G, Salvi F, Bruno B, Baldini L, Ferreri A, Patti C, Tarella C, Pileri S, Dodero A. Intensified chemo-immunotherapy with or without stem cell transplantation in newly diagnosed patients with peripheral T-cell lymphoma. Leukemia. 2014 Sep;28(9):1885-91. Epub 2014 Feb 20. link to original article contains verified protocol PubMed

Consolidation and/or maintenance after upfront therapy

BEAM, then auto HSCT

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BEAM: BiCNU (Carmustine), Etoposide, Ara-C (Cytarabine), Melphalan

Regimen

Study Evidence
d'Amore et al. 2012 (NLG-T-01) Non-randomized

Chemotherapy

Supportive therapy

  • Autologous stem cells re-infused on day 0
  • (described in some publications)
  • Filgrastim (Neupogen) by the following weight-based criteria:
    • Less than 70 kg: 300 mcg SC once per day, starting on day +7 after stem cell transplant
    • More than 70 kg (reference did not clarify which dosage to use for patients who are exactly 70 kg): 480 mcg SC once per day, starting on day +7 after stem cell transplant
  • Trimethoprim-Sulfamethoxazole (Bactrim DS) 160/800 mg PO twice per day on Monday and Thursdays, until 6 months after BEAM
  • Ciprofloxacin (Cipro) 500 mg PO twice per day while ANC less than 500/μL
  • Antifungal prophylaxis with one of the following:
  • Acyclovir (Zovirax) 400 mg PO three times per day while ANC less than 500/μL

One course

References

  1. NLG-T-01: d'Amore F, Relander T, Lauritzsen GF, Jantunen E, Hagberg H, Anderson H, Holte H, Österborg A, Merup M, Brown P, Kuittinen O, Erlanson M, Østenstad B, Fagerli UM, Gadeberg OV, Sundström C, Delabie J, Ralfkiaer E, Vornanen M, Toldbod HE. Up-front autologous stem-cell transplantation in peripheral T-cell lymphoma: NLG-T-01. J Clin Oncol. 2012 Sep 1;30(25):3093-9. Epub 2012 Jul 30. link to original article contains verified protocol PubMed

Cyclophosphamide & TBI, then auto HSCT

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Cy/TBI: Cyclophosphamide & Total Body Irradiation

Regimen

Study Evidence
Reimer et al. 2004 Phase II

Chemotherapy

Radiotherapy

Supportive therapy

One course

References

  1. Reimer P, Schertlin T, Rüdiger T, Geissinger E, Roth S, Kunzmann V, Weissinger F, Nerl C, Schmitz N, Müller-Hermelink HK, Wilhelm M. Myeloablative radiochemotherapy followed by autologous peripheral blood stem cell transplantation as first-line therapy in peripheral T-cell lymphomas: first results of a prospective multicenter study. Hematol J. 2004;5(4):304-11. PubMed
    1. Update: Reimer P, Rüdiger T, Geissinger E, Weissinger F, Nerl C, Schmitz N, Engert A, Einsele H, Müller-Hermelink HK, Wilhelm M. Autologous stem-cell transplantation as first-line therapy in peripheral T-cell lymphomas: results of a prospective multicenter study. J Clin Oncol. 2009 Jan 1;27(1):106-13. Epub 2008 Nov 24. link to original article PubMed

Radiation therapy

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Regimen

Study Evidence
Simon et al. 2010 (GOELAMS LTP95) Non-randomized portion of RCT

Preceding treatment

  • CHOP x 8 versus vVIP-rABVD

Radiotherapy

References

  1. GOELAMS-LTP95: Simon A, Peoch M, Casassus P, Deconinck E, Colombat P, Desablens B, Tournilhac O, Eghbali H, Foussard C, Jaubert J, Vilque JP, Rossi JF, Lucas V, Delwail V, Thyss A, Maloisel F, Milpied N, le Gouill S, Lamy T, Gressin R. Upfront VIP-reinforced-ABVD (VIP-rABVD) is not superior to CHOP/21 in newly diagnosed peripheral T cell lymphoma: results of the randomized phase III trial GOELAMS-LTP95. Br J Haematol. 2010 Oct;151(2):159-66. Epub 2010 Aug 25. link to original article contains verified protocol PubMed

TFC, then allo HSCT

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TFC: Thiotepa, Fludarabine, Cyclophosphamide

Regimen

Study Evidence
Corradini et al. 2002 Non-randomized
Corradini et al. 2014 Phase II

Details to be completed.

Preceding treatment

Chemotherapy

References

  1. Corradini P, Tarella C, Olivieri A, Gianni AM, Voena C, Zallio F, Ladetto M, Falda M, Lucesole M, Dodero A, Ciceri F, Benedetti F, Rambaldi A, Sajeva MR, Tresoldi M, Pileri A, Bordignon C, Bregni M. Reduced-intensity conditioning followed by allografting of hematopoietic cells can produce clinical and molecular remissions in patients with poor-risk hematologic malignancies. Blood. 2002 Jan 1;99(1):75-82. link to original article PubMed
  2. Corradini P, Vitolo U, Rambaldi A, Miceli R, Patriarca F, Gallamini A, Olivieri A, Benedetti F, Todeschini G, Rossi G, Salvi F, Bruno B, Baldini L, Ferreri A, Patti C, Tarella C, Pileri S, Dodero A. Intensified chemo-immunotherapy with or without stem cell transplantation in newly diagnosed patients with peripheral T-cell lymphoma. Leukemia. 2014 Sep;28(9):1885-91. Epub 2014 Feb 20. link to original article contains verified protocol PubMed

Relapsed or refractory, randomized data

DHAP

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DHAP: Dexamethasone, High-dose Ara-C (Cytarabine), Platinol (Cisplatin)

Regimen

Study Evidence Comparator Efficacy
Crump et al. 2014 (NCIC-CTG LY.12) Phase III, <20 in this arm (C) GDP Seems non-inferior

Chemotherapy

21-day cycle for up to 3 cycles

References

  1. Crump M, Kuruvilla J, Couban S, MacDonald DA, Kukreti V, Kouroukis CT, Rubinger M, Buckstein R, Imrie KR, Federico M, Di Renzo N, Howson-Jan K, Baetz T, Kaizer L, Voralia M, Olney HJ, Turner AR, Sussman J, Hay AE, Djurfeldt MS, Meyer RM, Chen BE, Shepherd LE. Randomized comparison of gemcitabine, dexamethasone, and cisplatin versus dexamethasone, cytarabine, and cisplatin chemotherapy before autologous stem-cell transplantation for relapsed and refractory aggressive lymphomas: NCIC-CTG LY.12. J Clin Oncol. 2014 Nov 1;32(31):3490-6. Epub 2014 Sep 29. link to original article contains verified protocol PubMed

GDP

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GDP: Gemcitabine, Dexamethasone, Platinol (Cisplatin)

Regimen

Study Evidence Comparator Efficacy
Crump et al. 2014 (NCIC-CTG LY.12) Phase III, <20 in this arm (E) DHAP Seems non-inferior

Chemotherapy

21-day cycle for up to 3 cycles

References

  1. Crump M, Kuruvilla J, Couban S, MacDonald DA, Kukreti V, Kouroukis CT, Rubinger M, Buckstein R, Imrie KR, Federico M, Di Renzo N, Howson-Jan K, Baetz T, Kaizer L, Voralia M, Olney HJ, Turner AR, Sussman J, Hay AE, Djurfeldt MS, Meyer RM, Chen BE, Shepherd LE. Randomized comparison of gemcitabine, dexamethasone, and cisplatin versus dexamethasone, cytarabine, and cisplatin chemotherapy before autologous stem-cell transplantation for relapsed and refractory aggressive lymphomas: NCIC-CTG LY.12. J Clin Oncol. 2014 Nov 1;32(31):3490-6. Epub 2014 Sep 29. link to original article contains verified protocol PubMed

Alisertib

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Regimen

Study Evidence Comparator Efficacy
O'Connor et al. 2019 (LUMIERE) Phase III (E) Pralatrexate

Romidepsin

Gemcitabine

Seems non-inferior

Chemotherapy

21-day cycle for up to 3 cycles

References

  1. LUMIERE: Connor OA, Özcan M, Jacobsen ED, Roncero JM, Trotman J, Demeter J, Masszi T, Pereira J, Ramchandren R, Beaven A, Caballero D, Horwitz SM, Lennard A, Turgut M, Hamerschlak N, d'Amore FA, Foss F, Kim WS, Leonard JP, Zinzani PL, Chiattone CS, Hsi ED, Trümper L, Liu H, Sheldon-Waniga E, Ullmann CD, Venkatakrishnan K, Leonard EJ, Shustov AR; Lumiere Study Investigators. Randomized Phase III Study of Alisertib or Investigator's Choice (Selected Single Agent) in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma. J Clin Oncol. 2019 Mar 10;37(8):613-623. Epub 2019 Feb 1. link to original article contains verified protocol PubMed

Relapsed or refractory, non-randomized or retrospective data

Belinostat monotherapy

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Regimen

Study Evidence Efficacy
Foss et al. 2014 Phase II ORR: 25%
O'Connor et al. 2015 (BELIEF) Phase II ORR: 26%

Chemotherapy

21-day cycles

References

  1. 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. A phase II trial of belinostat (PXD101) in patients with relapsed or refractory peripheral or cutaneous T-cell lymphoma. Br J Haematol. 2015 Mar;168(6):811-9. Epub 2014 Nov 17. link to original article contains protocol PubMed
  2. BELIEF: O'Connor OA, Horwitz S, Masszi T, Van Hoof A, Brown P, Doorduijn J, Hess G, Jurczak W, Knoblauch P, Chawla S, Bhat G, Choi MR, Walewski J, Savage K, Foss F, Allen LF, Shustov A. Belinostat in patients with relapsed or refractory peripheral T-cell lymphoma: results of the pivotal phase II BELIEF (CLN-19) study. J Clin Oncol. 2015 Aug 10;33(23):2492-9. Epub 2015 Jun 22. link to original article contains verified protocol link to PMC article PubMed

Bendamustine monotherapy

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Regimen

Study Evidence Efficacy
Demaj et al. 2013 (BENTLY) Phase II ORR: 50%

Chemotherapy

21-day cycle for 6 cycles

References

  1. BENTLY: Damaj G, Gressin R, Bouabdallah K, Cartron G, Choufi B, Gyan E, Banos A, Jaccard A, Park S, Tournilhac O, Schiano-de Collela JM, Voillat L, Joly B, Le Gouill S, Saad A, Cony-Makhoul P, Vilque JP, Sanhes L, Schmidt-Tanguy A, Bubenheim M, Houot R, Diouf M, Marolleau JP, Béné MC, Martin A, Lamy T. Results from a prospective, open-label, phase II trial of bendamustine in refractory or relapsed T-cell lymphomas: the BENTLY trial. J Clin Oncol. 2013 Jan 1;31(1):104-10. Epub 2012 Oct 29. link to original article contains verified protocol PubMed

Bortezomib & Panobinostat

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Regimen

Study Evidence Efficacy
Tan et al. 2015 (SGH651) Phase II ORR: 43% (95% CI, 23-63)

Chemotherapy

21-day cycle for up to 8 cycles

References

  1. Tan D, Phipps C, Hwang WY, Tan SY, Yeap CH, Chan YH, Tay K, Lim ST, Lee YS, Kumar SG, Ng SC, Fadilah S, Kim WS, Goh YT; SGH651 Investigators. Panobinostat in combination with bortezomib in patients with relapsed or refractory peripheral T-cell lymphoma: an open-label, multicentre phase 2 trial. Lancet Haematol. 2015 Aug;2(8):e326-33. Epub 2015 Jul 7. link to original article contains verified protocol PubMed

Brentuximab vedotin monotherapy

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Regimen

Study Evidence Efficacy
Horwitz et al. 2014 (SGN35-012) Phase II ORR: 41%

Chemotherapy

21-day cycle until progression or unacceptable toxicity

References

  1. SGN35-012: Horwitz SM, Advani RH, Bartlett NL, Jacobsen ED, Sharman JP, O'Connor OA, Siddiqi T, Kennedy DA, Oki Y. Objective responses in relapsed T-cell lymphomas with single-agent brentuximab vedotin. Blood. 2014 May 15;123(20):3095-100. Epub 2014 Mar 20. link to original article contains verified protocol link to PMC article PubMed

Chidamide monotherapy

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Regimen

Study Evidence Efficacy
Shi et al. 2015 Phase II ORR: 28%

Chemotherapy

Continued indefinitely

References

  1. Shi Y, Dong M, Hong X, Zhang W, Feng J, Zhu J, Yu L, Ke X, Huang H, Shen Z, Fan Y, Li W, Zhao X, Qi J, Huang H, Zhou D, Ning Z, Lu X. Results from a multicenter, open-label, pivotal phase II study of chidamide in relapsed or refractory peripheral T-cell lymphoma. Ann Oncol. 2015 Aug;26(8):1766-71. Epub 2015 Jun 23. link to original article contains protocol PubMed

Forodesine monotherapy

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Regimen

Study Evidence Efficacy
Maruyama et al. 2018 Phase I/II ORR: 22%

Chemotherapy

Continued indefinitely

References

  1. Maruyama D, Tsukasaki K, Uchida T, Maeda Y, Shibayama H, Nagai H, Kurosawa M, Suehiro Y, Hatake K, Ando K, Yoshida I, Hidaka M, Murayama T, Okitsu Y, Tsukamoto N, Taniwaki M, Suzumiya J, Tamura K, Yamauchi T, Ueda R, Tobinai K. Multicenter phase 1/2 study of forodesine in patients with relapsed peripheral T cell lymphoma. Ann Hematol. 2018 Jul 5. [Epub ahead of print] Erratum in: Ann Hematol. 2018 Jul 27. link to original article contains protocol PubMed

Lenalidomide monotherapy

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Variant #1, limited duration

Study Evidence Efficacy
Morschhauser et al. 2013 (EXPECT) Phase II ORR: 41%

Chemotherapy

28-day cycle for up to 2 years

Variant #2, indefinite

Study Evidence Efficacy
Dueck et al. 2010 Phase II ORR: 30%

Chemotherapy

28-day cycles

References

  1. Dueck G, Chua N, Prasad A, Finch D, Stewart D, White D, van der Jagt R, Johnston J, Belch A, Reiman T. Interim report of a phase 2 clinical trial of lenalidomide for T-cell non-Hodgkin lymphoma. Cancer. 2010 Oct 1;116(19):4541-8. link to original article contains verified protocol PubMed
    1. Update: Toumishey E, Prasad A, Dueck G, Chua N, Finch D, Johnston J, van der Jagt R, Stewart D, White D, Belch A, Reiman T. Final report of a phase 2 clinical trial of lenalidomide monotherapy for patients with T-cell lymphoma. Cancer. 2015 Mar 1;121(5):716-23. Epub 2014 Oct 29. link to original article PubMed
  2. EXPECT: Morschhauser F, Fitoussi O, Haioun C, Thieblemont C, Quach H, Delarue R, Glaisner S, Gabarre J, Bosly A, Lister J, Li J, Coiffier B. A phase 2, multicentre, single-arm, open-label study to evaluate the safety and efficacy of single-agent lenalidomide (Revlimid®) in subjects with relapsed or refractory peripheral T-cell non-Hodgkin lymphoma: The EXPECT trial. Eur J Cancer. 2013 Sep;49(13):2869-76. Epub 2013 May 31. link to original article contains protocol PubMed

Mogamulizumab monotherapy

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Regimen

Study Evidence
Ogura et al. 2014 (KW-0761-004) Phase II

Chemotherapy

8-week course

References

  1. KW-0761-004: Ogura M, Ishida T, Hatake K, Taniwaki M, Ando K, Tobinai K, Fujimoto K, Yamamoto K, Miyamoto T, Uike N, Tanimoto M, Tsukasaki K, Ishizawa K, Suzumiya J, Inagaki H, Tamura K, Akinaga S, Tomonaga M, Ueda R. Multicenter phase II study of mogamulizumab (KW-0761), a defucosylated anti-cc chemokine receptor 4 antibody, in patients with relapsed peripheral T-cell lymphoma and cutaneous T-cell lymphoma. J Clin Oncol. 2014 Apr 10;32(11):1157-63. Epub 2014 Mar 10. link to original article contains protocol PubMed

Pralatrexate monotherapy

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Example orders

Regimen

Study Evidence Efficacy
O'Connor et al. 2011 (PROPEL) Phase II ORR: 29%

Chemotherapy

Supportive medications

7-week cycles

References

  1. PROPEL: O'Connor OA, Pro B, Pinter-Brown L, Bartlett N, Popplewell L, Coiffier B, Lechowicz MJ, Savage KJ, Shustov AR, Gisselbrecht C, Jacobsen E, Zinzani PL, Furman R, Goy A, Haioun C, Crump M, Zain JM, Hsi E, Boyd A, Horwitz S. Pralatrexate in patients with relapsed or refractory peripheral T-cell lymphoma: results from the pivotal PROPEL study. J Clin Oncol. 2011 Mar 20;29(9):1182-9. link to original article contains verified protocol link to PMC article PubMed

Romidepsin monotherapy

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Regimen

Study Evidence Efficacy Pt Population
Piekarz et al. 2011 Phase II ORR: 38% (95% CI 24-53) Median of 3 prior treatments (range 1-11)
Coiffier et al. 2012 Phase II ORR: Investigator assessment: 29%
Central review: 25% 		Median of 2 prior treatments (range 1-8)

Chemotherapy

28-day cycle for up to 6 cycles, with optional extension of treatment for patients with stable disease or response

References

  1. Piekarz RL, Frye R, Prince HM, Kirschbaum MH, Zain J, Allen SL, Jaffe ES, Ling A, Turner M, Peer CJ, Figg WD, Steinberg SM, Smith S, Joske D, Lewis I, Hutchins L, Craig M, Fojo AT, Wright JJ, Bates SE. Phase 2 trial of romidepsin in patients with peripheral T-cell lymphoma. Blood. 2011 Jun 2;117(22):5827-34. Epub 2011 Feb 25. link to original article contains verified protocol link to PMC article PubMed
  2. Coiffier B, Pro B, Prince HM, Foss F, Sokol L, Greenwood M, Caballero D, Borchmann P, Morschhauser F, Wilhelm M, Pinter-Brown L, Padmanabhan S, Shustov A, Nichols J, Carroll S, Balser J, Balser B, Horwitz S. Results from a pivotal, open-label, phase II study of romidepsin in relapsed or refractory peripheral T-cell lymphoma after prior systemic therapy. J Clin Oncol. 2012 Feb 20;30(6):631-6. Epub 2012 Jan 23. link to original article contains verified protocol PubMed
    1. Update: Coiffier B, Pro B, Prince HM, Foss F, Sokol L, Greenwood M, Caballero D, Morschhauser F, Wilhelm M, Pinter-Brown L, Padmanabhan Iyer S, Shustov A, Nielsen T, Nichols J, Wolfson J, Balser B, Horwitz S. Romidepsin for the treatment of relapsed/refractory peripheral T-cell lymphoma: pivotal study update demonstrates durable responses. J Hematol Oncol. 2014 Jan 23;7(1):11. link to original article link to PMC article PubMed
    2. Update: Foss F, Horwitz S, Pro B, Prince HM, Sokol L, Balser B, Wolfson J, Coiffier B. Romidepsin for the treatment of relapsed/refractory peripheral T cell lymphoma: prolonged stable disease provides clinical benefits for patients in the pivotal trial. J Hematol Oncol. 2016 Mar 10;9:22. link to original article link to PMC article PubMed

Consolidation after salvage therapy

FluBuCy, then allo HSCT

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FluBuCy: Fludarabine, Busulfan, Cyclophosphamide

Regimen

Study Evidence
Glass et al. 2014 (DSHNHL R3) Phase II

Chemotherapy

Immunotherapy

GVHD prophylaxis

One course

References

  1. DSHNHL R3: Glass B, Hasenkamp J, Wulf G, Dreger P, Pfreundschuh M, Gramatzki M, Silling G, Wilhelm C, Zeis M, Görlitz A, Pfeiffer S, Hilgers R, Truemper L, Schmitz N; on behalf of the German High-Grade Lymphoma Study Group. Rituximab after lymphoma-directed conditioning and allogeneic stem-cell transplantation for relapsed and refractory aggressive non-Hodgkin lymphoma (DSHNHL R3): an open-label, randomised, phase 2 trial. Lancet Oncol. 2014 Jun;15(7):757-66. Epub 2014 May 11. link to original article link to original protocol (in German) contains verified protocol PubMed

Investigational agents

These are drugs under study or approved outside of the United States, with at least some promising results for this disease.

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