Difference between revisions of "High-grade B-cell lymphoma"
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===References=== | ===References=== | ||
#'''LOTIS-2:''' Caimi PF, Ai W, Alderuccio JP, Ardeshna KM, Hamadani M, Hess B, Kahl BS, Radford J, Solh M, Stathis A, Zinzani PL, Havenith K, Feingold J, He S, Qin Y, Ungar D, Zhang X, Carlo-Stella C. Loncastuximab tesirine in relapsed or refractory diffuse large B-cell lymphoma (LOTIS-2): a multicentre, open-label, single-arm, phase 2 trial. Lancet Oncol. 2021 Jun;22(6):790-800. Epub 2021 May 11. [https://doi.org/10.1016/s1470-2045(21)00139-x link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/33989558/ PubMed] [https://clinicaltrials.gov/study/NCT03589469 NCT03589469] | #'''LOTIS-2:''' Caimi PF, Ai W, Alderuccio JP, Ardeshna KM, Hamadani M, Hess B, Kahl BS, Radford J, Solh M, Stathis A, Zinzani PL, Havenith K, Feingold J, He S, Qin Y, Ungar D, Zhang X, Carlo-Stella C. Loncastuximab tesirine in relapsed or refractory diffuse large B-cell lymphoma (LOTIS-2): a multicentre, open-label, single-arm, phase 2 trial. Lancet Oncol. 2021 Jun;22(6):790-800. Epub 2021 May 11. [https://doi.org/10.1016/s1470-2045(21)00139-x link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/33989558/ PubMed] [https://clinicaltrials.gov/study/NCT03589469 NCT03589469] | ||
| + | ==Tisagenlecleucel monotherapy {{#subobject:d68f14|Regimen=1}}== | ||
| + | <div class="toccolours" style="background-color:#eeeeee"> | ||
| + | ===Regimen {{#subobject:60fc19|Variant=1}}=== | ||
| + | {| class="wikitable" style="color:white; background-color:#404040" | ||
| + | |<small>'''FDA-recommended dose'''</small> | ||
| + | |- | ||
| + | |} | ||
| + | {| class="wikitable sortable" style="width: 80%; text-align:center;" | ||
| + | ! style="width: 25%" |Study | ||
| + | ! style="width: 25%" |Dates of enrollment | ||
| + | ! style="width: 25%" |[[Levels_of_Evidence#Evidence|Evidence]] | ||
| + | ! style="width: 25%" |[[Levels_of_Evidence#Efficacy|Efficacy]] | ||
| + | |- | ||
| + | |[https://doi.org/10.1056/NEJMoa1804980 Schuster et al. 2018 (JULIET)] | ||
| + | |2015-2017 | ||
| + | | style="background-color:#ffffbe" |Phase 2 (RT), fewer than 20 patients in this subgroup | ||
| + | | style="background-color:#9ebcda" |ORR: 59% (95% CI, 44-72) | ||
| + | |- | ||
| + | |} | ||
| + | ''Note: The range given is the FDA-recommended dose used in JULIET.'' | ||
| + | <div class="toccolours" style="background-color:#cbd5e8"> | ||
| + | ====Preceding treatment==== | ||
| + | *Lymphodepleting therapy with [[Autologous_HSCT#FC|FC]] or [[Autologous_HSCT#Bendamustine_monotherapy|Bendamustine]] | ||
| + | </div> | ||
| + | <div class="toccolours" style="background-color:#b3e2cd"> | ||
| + | ====Immunotherapy==== | ||
| + | *[[Tisagenlecleucel (Kymriah)]] 0.6 to 6 x 10<sup>8</sup> CTL019 transduced viable T-cells IV once on day 0 | ||
| + | '''One course''' | ||
| + | </div></div> | ||
| + | ===References=== | ||
| + | <!-- # '''Abstract:''' Schuster SJ, Bishop MR, Tam C, et al. Global Pivotal Phase 2 Trial of the CD19-Targeted Therapy CTL019 in Adult Patients with Relapsed or Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL)—an Interim Analysis. Hematological Oncology. 2017;35(S2):27. [https://doi.org/10.1002/hon.2437_6 link to abstract] --> | ||
| + | #'''JULIET:''' Schuster SJ, Bishop MR, Tam CS, Waller EK, Borchmann P, McGuirk JP, Jäger U, Jaglowski S, Andreadis C, Westin JR, Fleury I, Bachanova V, Foley SR, Ho PJ, Mielke S, Magenau JM, Holte H, Pantano S, Pacaud LB, Awasthi R, Chu J, Anak Ö, Salles G, Maziarz RT; JULIET Investigators. Tisagenlecleucel in Adult Relapsed or Refractory Diffuse Large B-Cell Lymphoma. N Engl J Med. 2019 Jan 3;380(1):45-56. Epub 2018 Dec 1. [https://doi.org/10.1056/NEJMoa1804980 link to original article] [https://pubmed.ncbi.nlm.nih.gov/30501490/ PubMed] [https://clinicaltrials.gov/study/NCT02445248 NCT02445248] | ||
| + | ##'''Update:''' Schuster SJ, Tam CS, Borchmann P, Worel N, McGuirk JP, Holte H, Waller EK, Jaglowski S, Bishop MR, Damon LE, Foley SR, Westin JR, Fleury I, Ho PJ, Mielke S, Teshima T, Janakiram M, Hsu JM, Izutsu K, Kersten MJ, Ghosh M, Wagner-Johnston N, Kato K, Corradini P, Martinez-Prieto M, Han X, Tiwari R, Salles G, Maziarz RT. Long-term clinical outcomes of tisagenlecleucel in patients with relapsed or refractory aggressive B-cell lymphomas (JULIET): a multicentre, open-label, single-arm, phase 2 study. Lancet Oncol. 2021 Oct;22(10):1403-1415. Epub 2021 Sep 10. [https://doi.org/10.1016/s1470-2045(21)00375-2 link to original article] [https://pubmed.ncbi.nlm.nih.gov/34516954/ PubMed] | ||
| + | |||
[[Category:High-grade B-cell lymphoma regimens]] | [[Category:High-grade B-cell lymphoma regimens]] | ||
[[Category:Disease-specific pages]] | [[Category:Disease-specific pages]] | ||
[[Category:Aggressive non-Hodgkin lymphomas]] | [[Category:Aggressive non-Hodgkin lymphomas]] | ||
[[Category:B-cell lymphomas]] | [[Category:B-cell lymphomas]] | ||
Revision as of 18:36, 2 August 2023
Section editor transclusions Note: High-grade B-cell lymphoma (HGBL) was not considered as a named entity until the 2016 revision of the WHO guidelines, and includes entities such as double-hit lymphoma and triple-hit lymphoma which were previously classified under diffuse large B-cell lymphoma. We will populate this page with relevant regimens over time.
7 regimens on this page
7 variants on this page
|
Relapsed or refractory, subsequent lines of therapy
Axicabtagene ciloleucel monotherapy
Regimen
| FDA-recommended dose |
| Study | Dates of enrollment | Evidence | Efficacy |
|---|---|---|---|
| Locke et al. 2017 (ZUMA-1) | 2015-2016 | Phase 1/2 (RT), fewer than 20 patients in this subgroup | ORR: 83%; CR: 59%
Median OS: not reached Median PFS: 6 months Median duration of response: 11 months |
Preceding treatment
- Lymphodepletion with FC
Immunotherapy
- Axicabtagene ciloleucel (Yescarta) target dose of 2 × 106 CAR T cells/kg IV once on day 0
Supportive therapy
- Acetaminophen (Tylenol) 650 mg PO once on day 0, approximately 60 minutes prior to axi-cel
- Diphenhydramine (Benadryl) 12.5 mg IV or PO once on day 0, approximately 60 minutes prior to axi-cel
One course; patients with initial response and disease progression at least 3 months later could be retreated
References
- ZUMA-1: Locke FL, Neelapu SS, Bartlett NL, Siddiqi T, Chavez JC, Hosing CM, Ghobadi A, Budde LE, Bot A, Rossi JM, Jiang Y, Xue AX, Elias M, Aycock J, Wiezorek J, Go WY. Phase 1 results of ZUMA-1: A multicenter study of KTE-C19 anti-CD19 CAR T cell therapy in refractory aggressive lymphoma. Mol Ther. 2017 Jan 4;25(1):285-295. Epub 2017 Jan 4. link to original article link to PMC article PubMed NCT02348216
- Update: Neelapu SS, Locke FL, Bartlett NL, Lekakis LJ, Miklos DB, Jacobson CA, Braunschweig I, Oluwole OO, Siddiqi T, Lin Y, Timmerman JM, Stiff PJ, Friedberg JW, Flinn IW, Goy A, Hill BT, Smith MR, Deol A, Farooq U, McSweeney P, Munoz J, Avivi I, Castro JE, Westin JR, Chavez JC, Ghobadi A, Komanduri KV, Levy R, Jacobsen ED, Witzig TE, Reagan P, Bot A, Rossi J, Navale L, Jiang Y, Aycock J, Elias M, Chang D, Wiezorek J, Go WY. Axicabtagene ciloleucel CAR T-cell therapy in refractory large B-cell lymphoma. N Engl J Med. 2017 Dec 28;377(26):2531-2544. Epub 2017 Dec 10. link to original article contains dosing details in manuscript link to PMC article PubMed
- Update: Locke FL, Ghobadi A, Jacobson CA, Miklos DB, Lekakis LJ, Oluwole OO, Lin Y, Braunschweig I, Hill BT, Timmerman JM, Deol A, Reagan PM, Stiff P, Flinn IW, Farooq U, Goy A, McSweeney PA, Munoz J, Siddiqi T, Chavez JC, Herrera AF, Bartlett NL, Wiezorek JS, Navale L, Xue A, Jiang Y, Bot A, Rossi JM, Kim JJ, Go WY, Neelapu SS. Long-term safety and activity of axicabtagene ciloleucel in refractory large B-cell lymphoma (ZUMA-1): a single-arm, multicentre, phase 1-2 trial. Lancet Oncol. 2019 Jan;20(1):31-42. Epub 2018 Dec 2. link to original article link to PMC article contains dosing details in manuscript PubMed
- Update: Neelapu SS, Jacobson CA, Ghobadi A, Miklos DB, Lekakis LJ, Oluwole OO, Lin Y, Braunschweig I, Hill BT, Timmerman JM, Deol A, Reagan PM, Stiff P, Flinn IW, Farooq U, Goy AH, McSweeney PA, Munoz J, Siddiqi T, Chavez JC, Herrera AF, Bartlett NL, Bot AA, Shen RR, Dong J, Singh K, Miao H, Kim JJ, Zheng Y, Locke FL. Five-year follow-up of ZUMA-1 supports the curative potential of axicabtagene ciloleucel in refractory large B-cell lymphoma. Blood. 2023 May 11;141(19):2307-2315. link to original article PubMed
Lisocabtagene maraleucel monotherapy
Regimen
| Study | Dates of enrollment | Evidence |
|---|---|---|
| Abramson et al. 2020 (TRANSCEND NHL-001) | 2016-01-11 to 2019-07-05 | Phase 1 (RT) |
Immunotherapy
- Lisocabtagene maraleucel (Breyanzi) target dose of 100 x 106 CAR T cells IV once on day 0
One course
References
- TRANSCEND NHL-001: Abramson JS, Palomba ML, Gordon LI, Lunning MA, Wang M, Arnason J, Mehta A, Purev E, Maloney DG, Andreadis C, Sehgal A, Solomon SR, Ghosh N, Albertson TM, Garcia J, Kostic A, Mallaney M, Ogasawara K, Newhall K, Kim Y, Li D, Siddiqi T. Lisocabtagene maraleucel for patients with relapsed or refractory large B-cell lymphomas (TRANSCEND NHL 001): a multicentre seamless design study. Lancet. 2020 Sep 19;396(10254):839-852. Epub 2020 Sep 1. link to original article contains dosing details in abstract PubMed NCT02631044
Loncastuximab tesirine monotherapy
Regimen
| FDA-recommended dose |
| Study | Dates of enrollment | Evidence |
|---|---|---|
| Caimi et al. 2021 (LOTIS-2) | 2018-2019 | Phase 2 (RT) |
Antibody-drug conjugate therapy
- Loncastuximab tesirine (Zynlonta) as follows:
- Cycles 1 & 2: 0.15 mg/kg IV over 30 minutes once on day 1
- Cycle 3 onwards: 0.075 mg/kg IV over 30 minutes once on day 1
Supportive therapy
- Dexamethasone (Decadron) 4 mg IV or PO twice per day on days -1 to 2 (3 days total)
21-day cycles for up to 18 cycles (1 year)
References
- LOTIS-2: Caimi PF, Ai W, Alderuccio JP, Ardeshna KM, Hamadani M, Hess B, Kahl BS, Radford J, Solh M, Stathis A, Zinzani PL, Havenith K, Feingold J, He S, Qin Y, Ungar D, Zhang X, Carlo-Stella C. Loncastuximab tesirine in relapsed or refractory diffuse large B-cell lymphoma (LOTIS-2): a multicentre, open-label, single-arm, phase 2 trial. Lancet Oncol. 2021 Jun;22(6):790-800. Epub 2021 May 11. link to original article contains dosing details in abstract PubMed NCT03589469
Tisagenlecleucel monotherapy
Regimen
| FDA-recommended dose |
| Study | Dates of enrollment | Evidence | Efficacy |
|---|---|---|---|
| Schuster et al. 2018 (JULIET) | 2015-2017 | Phase 2 (RT), fewer than 20 patients in this subgroup | ORR: 59% (95% CI, 44-72) |
Note: The range given is the FDA-recommended dose used in JULIET.
Preceding treatment
- Lymphodepleting therapy with FC or Bendamustine
Immunotherapy
- Tisagenlecleucel (Kymriah) 0.6 to 6 x 108 CTL019 transduced viable T-cells IV once on day 0
One course
References
- JULIET: Schuster SJ, Bishop MR, Tam CS, Waller EK, Borchmann P, McGuirk JP, Jäger U, Jaglowski S, Andreadis C, Westin JR, Fleury I, Bachanova V, Foley SR, Ho PJ, Mielke S, Magenau JM, Holte H, Pantano S, Pacaud LB, Awasthi R, Chu J, Anak Ö, Salles G, Maziarz RT; JULIET Investigators. Tisagenlecleucel in Adult Relapsed or Refractory Diffuse Large B-Cell Lymphoma. N Engl J Med. 2019 Jan 3;380(1):45-56. Epub 2018 Dec 1. link to original article PubMed NCT02445248
- Update: Schuster SJ, Tam CS, Borchmann P, Worel N, McGuirk JP, Holte H, Waller EK, Jaglowski S, Bishop MR, Damon LE, Foley SR, Westin JR, Fleury I, Ho PJ, Mielke S, Teshima T, Janakiram M, Hsu JM, Izutsu K, Kersten MJ, Ghosh M, Wagner-Johnston N, Kato K, Corradini P, Martinez-Prieto M, Han X, Tiwari R, Salles G, Maziarz RT. Long-term clinical outcomes of tisagenlecleucel in patients with relapsed or refractory aggressive B-cell lymphomas (JULIET): a multicentre, open-label, single-arm, phase 2 study. Lancet Oncol. 2021 Oct;22(10):1403-1415. Epub 2021 Sep 10. link to original article PubMed