Cellular therapy conditioning regimens

Back to Top
Unlike most other regimen pages, this one is not disease-specific. Rather, this is a gathering point for all CAR T-cel and other immune effector cell (IEC) conditioning regimens. Following the conventions of allogeneic transplant, unless otherwise specified, the day before cell infusion is day -1, the day of cell infusion is day 0, and the day after cell infusion is day +1.
These links will take you to highly related pages:
*Allogeneic HSCT
Last updated on 2024-07-23:4 regimens on this page
6 variants on this page
=Low-dose conditioning regimens for cellular therapy=
==Bendamustine monotherapy==
===Regimen===
Study 	Dates of enrollment 	Evidence
Schuster et al. 2018 (JULIET)	2015-07-29 to 2017-11-02	Phase 2
Note: Lymphodepleting chemotherapy may be omitted if a patient’s white blood cell count is less than or equal to 1 x 109/L within 1 week prior to tisagenlecleucel infusion. This regimen is suggested if a patient experienced a previous grade 4 hemorrhagic cystitis with cyclophosphamide or demonstrates resistance to a previous cyclophosphamide-containing regimen.
====Chemotherapy====
*Bendamustine 90 mg/m2 IV once per day on days 1 & 2
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 EuroPMC 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 EuroPMC
==Cytarabine & Etoposide (CYVE)==
CYVE: CYtarabine & VEpeside (Etoposide)
===Regimen===
Study 	Dates of enrollment	Evidence
Maude et al. 2018 (ELIANA)	2015-2017 	Phase 2
Note: This regimen is intended for patients with a history of grade 4 hemorrhagic cystitis from cyclophosphamide, or chemorefractory disease in the context of cyclophosphamide. CAR-T cells are to be given 2 to 14 days after completion of lymphodepleting therapy.
====Chemotherapy====
*Cytarabine (Ara-C) 500 mg/m2 IV once per day on days 1 & 2
*Etoposide (Vepesid) 150 mg/m2 IV once per day on days 1 to 3
One course
===References===
# ELIANA: Maude SL, Laetsch TW, Buechner J, Rives S, Boyer M, Bittencourt H, Bader P, Verneris MR, Stefanski HE, Myers GD, Qayed M, De Moerloose B, Hiramatsu H, Schlis K, Davis KL, Martin PL, Nemecek ER, Yanik GA, Peters C, Baruchel A, Boissel N, Mechinaud F, Balduzzi A, Krueger J, June CH, Levine BL, Wood P, Taran T, Leung M, Mueller KT, Zhang Y, Sen K, Lebwohl D, Pulsipher MA, Grupp SA. Tisagenlecleucel in children and young adults with B-cell lymphoblastic leukemia. N Engl J Med. 2018 Feb 1;378(5):439-448. link to original article link to supplementary protocol dosing details in supplement have been reviewed by our editors link to PMC article EuroPMC NCT02435849
==Cyclophosphamide & Fludarabine (FC)==
FC: Fludarabine & Cyclophosphamide
===Regimen variant #1, 75/750===
Study 	Dates of enrollment 	Evidence
Schuster et al. 2018 (JULIET)	2015-07-29 to 2017-11-02	Phase 2
Note: Lymphodepleting chemotherapy may be omitted if a patient’s white blood cell count is less than or equal to 1 x 109/L within 1 week prior to tisagenlecleucel infusion.
====Chemotherapy====
*Fludarabine (Fludara) 25 mg/m2 IV once per day on days 1 to 3
*Cyclophosphamide (Cytoxan) 250 mg/m2 IV once per day on days 1 to 3
One course
===Regimen variant #2, 90/900===
Study 	Dates of enrollment 	Evidence
Abramson et al. 2020 (TRANSCEND NHL-001)	2016-01-11 to 2019-07-05	Phase 1 (RT)
====Chemotherapy====
*Fludarabine (Fludara) 30 mg/m2 IV once per day on days 1 to 3
*Cyclophosphamide (Cytoxan) 300 mg/m2 IV once per day on days 1 to 3
One course
===Regimen variant #3, 90/1500===
Study 	Dates of enrollment	Evidence
Locke et al. 2017 (ZUMA-1)	2015-11 to 2016-09 	Phase 1/2
====Chemotherapy====
*Fludarabine (Fludara) 30 mg/m2 IV once per day on days -5 to -3
*Cyclophosphamide (Cytoxan) 500 mg/m2 IV once per day on days -5 to -3
One course
===Regimen variant #4, 120/1000===
Study 	Dates of enrollment	Evidence
Maude et al. 2018 (ELIANA)	2015-2017 	Phase 2
Note: CAR-T cells were to be given 2 to 14 days after completion of lymphodepleting therapy.
====Chemotherapy====
*Fludarabine (Fludara) 30 mg/m2 IV once per day on days 1 to 4
*Cyclophosphamide (Cytoxan) 500 mg/m2 IV once per day on days 1 & 2
One course
===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 dosing details in manuscript have been reviewed by our editors EuroPMC 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 dosing details in manuscript have been reviewed by our editors link to PMC article EuroPMC
##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 dosing details in manuscript have been reviewed by our editors EuroPMC
# ELIANA: Maude SL, Laetsch TW, Buechner J, Rives S, Boyer M, Bittencourt H, Bader P, Verneris MR, Stefanski HE, Myers GD, Qayed M, De Moerloose B, Hiramatsu H, Schlis K, Davis KL, Martin PL, Nemecek ER, Yanik GA, Peters C, Baruchel A, Boissel N, Mechinaud F, Balduzzi A, Krueger J, June CH, Levine BL, Wood P, Taran T, Leung M, Mueller KT, Zhang Y, Sen K, Lebwohl D, Pulsipher MA, Grupp SA. Tisagenlecleucel in children and young adults with B-cell lymphoblastic leukemia. N Engl J Med. 2018 Feb 1;378(5):439-448. link to original article link to supplementary protocol dosing details in supplement have been reviewed by our editors link to PMC article EuroPMC NCT02435849
# 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 EuroPMC 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 EuroPMC
#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 dosing details in manuscript have been reviewed by our editors EuroPMC NCT02631044
##Update: Abramson JS, Palomba ML, Gordon LI, Lunning M, Wang M, Arnason J, Purev E, Maloney DG, Andreadis C, Sehgal A, Solomon SR, Ghosh N, Dehner C, Kim Y, Ogasawara K, Kostic A, Siddiqi T. Two-year follow-up of lisocabtagene maraleucel in relapsed or refractory large B-cell lymphoma in TRANSCEND NHL 001. Blood. 2024 Feb 1;143(5):404-416. link to original article EuroPMC
=Intensified conditioning regimens for cellular therapy=
==Cyclophosphamide, Etoposide, Fludarabine==
===Regimen===
Study 	Dates of enrollment	Evidence
Hu et al. 2024 (CD7-001)	2021-11 to 2023-09 	Phase 1
====Chemotherapy====
*Fludarabine (Fludara) 30 mg/m2 IV once per day on days -5 to -1
*Etoposide (Vepesid) 100 mg/m2 IV once per day on days -5 to -1
*Cyclophosphamide (Cytoxan) 300 mg/m2 IV once per day on days -5 to -1
One course
===References===
#CD7-001: Hu Y, Zhang M, Yang T, Mo Z, Wei G, Jing R, Zhao H, Chen R, Zu C, Gu T, Xiao P, Hong R, Feng J, Fu S, Kong D, Xu H, Cui J, Huang S, Liang B, Yuan X, Cui Q, Guo H, Yu Y, Feng Y, Jin C, Ren J, Chang AH, Wang D, Huang H. Sequential CD7 CAR T-Cell Therapy and Allogeneic HSCT without GVHD Prophylaxis. N Engl J Med. 2024 Apr 25;390(16):1467-1480. link to original article EuroPMC NCT04599556
Category:Cellular therapy regimens
Category:Site-agnostic regimens