High activity of the new myeloablative regimen of gemcitabine/clofarabine/busulfan for allogeneic transplant for aggressive lymphomas.
Journal
Bone marrow transplantation
ISSN: 1476-5365
Titre abrégé: Bone Marrow Transplant
Pays: England
ID NLM: 8702459
Informations de publication
Date de publication:
28 Sep 2024
28 Sep 2024
Historique:
received:
07
05
2024
accepted:
06
08
2024
revised:
21
07
2024
medline:
29
9
2024
pubmed:
29
9
2024
entrez:
28
9
2024
Statut:
aheadofprint
Résumé
Refractory aggressive lymphomas can be treated with allo-SCT, pursuing a graft-vs-lymphoma effect. While reduced intensity conditioning is safe, tumors often progress rapidly, indicating the need for more active conditioning regimens. The preclinical synergy we saw between gemcitabine (Gem), clofarabine (Clo) and busulfan (Bu) against lymphoma cell lines led us to study Gem/Clo/Bu clinically. Eligibility: age 12-65, refractory aggressive B-NHL, T-NHL or Hodgkin, with a matched donor. Infusional Gem was dose-escalated on days (d) -6 and -4 (475-975 mg/m
Identifiants
pubmed: 39341929
doi: 10.1038/s41409-024-02394-0
pii: 10.1038/s41409-024-02394-0
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
© 2024. The Author(s).
Références
Sureda A, Canals C, Arranz R, Caballero D, Ribera JM, Brune M, et al. Allogeneic stem cell transplantation after reduced intensity conditioning in patients with relapsed or refractory Hodgkin’s lymphoma. Results of the HDR-ALLO study – a prospective clinical trial by the Grupo Espanol de Linfomas/Trasplante de Medula Osea (GEL/TAMO) and the Lymphoma Working Party of the European Group for Blood and Marrow Transplantation. Haematologica. 2012;97:310–7.
pubmed: 21993674
pmcid: 3269494
doi: 10.3324/haematol.2011.045757
Bishop MR, Dean RM, Steinberg SM, Odom J, Pavletic SZ, Chow C, et al. Clinical evidence of a graft-versus-lymphoma effect against relapsed diffuse large B-cell lymphoma after allogeneic hematopoietic stem-cell transplantation. Ann Oncol. 2008;19:1935–40.
pubmed: 18684698
pmcid: 2733078
doi: 10.1093/annonc/mdn404
Locke FL, Miklos DB, Jacobson CA, Perales MA, Kersten MJ, Oluwole OO, et al. Axicabtagene ciloleucel as second-line therapy for large B-cell lymphoma. N Engl J Med. 2022;386:640–54.
pubmed: 34891224
doi: 10.1056/NEJMoa2116133
Abramson JS, Solomon SR, Arnason J, Johnston PB, Glass B, Bachanova V, et al. Lisocabtagene maraleucel as second-line therapy for large B-cell lymphoma: primary analysis of the phase 3 TRANSFORM study. Blood. 2023;141:1675–84.
pubmed: 36542826
doi: 10.1182/blood.2022018730
Chong EA, Rulela M, Schuster SJ. Five-year outcomes for refractory B-cell lymphomas with CAR T-cell therapy. N Engl J Med. 2021;384:673–4.
pubmed: 33596362
doi: 10.1056/NEJMc2030164
Di Blasi R, Le Gouill S, Bachy E, Cartron G, Beauvais D, Bras FL, et al. Outcomes of patients with s B-cell lymphoma after failure of anti-CD19 CAR T-cell therapy: a DESCAR-T analysis. Blood. 2022;40:2584–93.
doi: 10.1182/blood.2022016945
van Besien K, Thall P, Korbling M, Pugh WC, Khouri I, Mehra R, et al. Allogeneic transplantation for recurrent or refractory non-Hodgkin’s lymphoma with poor prognostic features after conditioning with thiotepa, busulfan, and cyclophosphamide: experience in 44 consecutive patients. Biol Blood Marrow Transplant. 1997;3:150–6.
pubmed: 9310192
Przepiorka D, Van Besien K, Khouri I, Hagemeister F, Samuels B, Folloder J, et al. Carmustine, etoposide, cytarabine and melphalan as a preparative regimen for allogeneic transplantation for high-risk malignant lymphoma. Ann Oncol. 1999;10:527–32.
pubmed: 10416001
doi: 10.1093/oxfordjournals.annonc.a010369
Aksentijevich I, Jones RJ, Ambinder RF, Garrett-Mayer E, Flinn IW. Clinical outcome following autologous and allogeneic blood and marrow transplantation for relapsed diffuse large-cell non-Hodgkin’s lymphoma. Biol Blood Marrow Transplant. 2006;12:965–72.
pubmed: 16920563
doi: 10.1016/j.bbmt.2006.05.018
Khouri IF, Saliba RM, Giralt SA, Lee MS, Okoroji GJ, Hagemeister FB, et al. Nonablative allogeneic hematopoietic transplantation as adoptive immunotherapy for indolent lymphoma: low incidence of toxicity, acute graft-versus-host disease, and treatment-related mortality. Blood. 2001;98:3595–9.
pubmed: 11739162
doi: 10.1182/blood.V98.13.3595
Shea T, Johnson J, Westervelt P, Farag S, McCarty J, Bashey A, et al. Reduced-intensity allogeneic transplantation provides high event-free and overall survival in patients with advanced indolent B cell malignancies: CALGB 109901. Biol Blood Marrow Transplant. 2011;17:1395–403.
pubmed: 21296675
pmcid: 3134602
doi: 10.1016/j.bbmt.2011.01.016
Robinson SP, Goldstone AH, Mackinnon S, Carella A, Russell N, Ruiz de Elvira C, et al. Chemoresistant or aggressive lymphoma predicts for a poor outcome following reduced-intensity allogeneic progenitor cell transplantation: an analysis from the Lymphoma Working Party of the European Group for Blood and Bone Marrow Transplantation. Blood. 2002;100:4310–6.
pubmed: 12393626
doi: 10.1182/blood-2001-11-0107
Morris E, Thomson K, Craddock C, Mahendra P, Milligan D, Cook G, et al. Outcomes after alemtuzumab-containing reduced-intensity allogeneic transplantation regimen for relapsed and refractory non-Hodgkin lymphoma. Blood. 2004;104:3865–71.
pubmed: 15304395
doi: 10.1182/blood-2004-03-1105
Genadieva-Stavrik S, Boumendil A, Dreger P, Peggs K, Briones J, Corradini P, et al. Myeloablative versus reduced intensity allogeneic stem cell transplantation for relapsed/refractory Hodgkin’s lymphoma in recent years: a retrospective analysis of the Lymphoma Working Party of the European Group for Blood and Marrow Transplantation. Ann Oncol. 2016;27:2251–7.
pubmed: 28007754
doi: 10.1093/annonc/mdw421
Rodriguez R, Nademanee A, Ruel N, Smith E, Krishnan A, Popplewell L, et al. Comparison of reduced-intensity and conventional myeloablative regimens for allogeneic transplantation in non-Hodgkin’s lymphoma. Biol Blood Marrow Transplant. 2006;12:1326–34.
pubmed: 17162215
doi: 10.1016/j.bbmt.2006.08.035
Hari P, Carreras J, Zhang M-J, Gale RP, Bolwell BJ, Bredeson CN, et al. Allogeneic transplants in follicular lymphoma: higher risk of disease progression after reduced-intensity compared to myeloablative conditioning. Biol Blood Marrow Transplant. 2008;14:236–45.
pubmed: 18215784
pmcid: 2531158
doi: 10.1016/j.bbmt.2007.11.004
Valdez BC, Nieto Y, Murray D, Li Y, Wang G, Champlin RE, et al. Epigenetic modifiers enhance the synergistic cytotoxicity of combined nucleoside analog-DNA alkylating agents in lymphoma cell lines. Exp Hematol. 2012;40:800–10.
pubmed: 22687754
pmcid: 3447105
doi: 10.1016/j.exphem.2012.06.001
Ji J, Valdez BC, Li Y, Liu Y, Teo EC, Nieto Y, et al. Cladribine, gemcitabine, busulfan, and SAHA combination as a potential pretransplant conditioning regimen for lymphomas: a preclinical study. Exp Hematol. 2016;44:458–65.
pubmed: 26976752
pmcid: 4864055
doi: 10.1016/j.exphem.2016.03.001
De Lima M, Couriel D, Thall PF, Wang X, Madden T, Jones R, et al. Once-daily intravenous busulfan and fludarabine: clinical and pharmacokinetic results of a myeloablative, reduced-toxicity conditioning regimen for allogeneic stem cell transplantation in AML and MDS. Blood. 2004;104:857–64.
pubmed: 15073038
doi: 10.1182/blood-2004-02-0414
Andersson BS, De Lima M, Thall PF, Wang X, Couriel D, Korbling M, et al. Once daily i.v. busulfan and fludarabine (i.v. Bu-Flu) compares favorably with i.v. busulfan and cyclophosphamide (i.v. BuCy2) as pretransplant conditioning therapy in AML/MDS. Biol Blood Marrow Transplant. 2008;14:672–84.
pubmed: 18489993
pmcid: 4230823
doi: 10.1016/j.bbmt.2008.03.009
Andersson BS, Thall PF, Ma J, Valdez BC, Bassett R Jr., Chen J, et al. A randomized phase III study of pretransplant conditioning for AML/MDS with fludarabine and once daily IV busulfan ± clofarabine in allogeneic stem cell transplantation. Bone Marrow Transplant. 2022;57:1295–303.
pubmed: 35610308
pmcid: 9352570
doi: 10.1038/s41409-022-01705-7
Kebriaei P, Basset R, Ledesma C, Ciurea S, Parmar S, Shpall EJ, et al. Clofarabine combined with busulfan provides excellent disease control in adult patients with acute lymphoblastic leukemia undergoing allogeneic hematopoietic stem cell transplantation. Biol Blood Marrow Transplant. 2012;18:1819–26.
pubmed: 22750645
pmcid: 4319530
doi: 10.1016/j.bbmt.2012.06.010
Kebriaei P, Bassett R, Lyons G, Valdez B, Ledesma C, Rondon G, et al. Clofarabine plus busulfan is an effective conditioning regimen for allogeneic hematopoietic stem cell transplantation in patients with acute lymphoblastic leukemia: long-term study results. Biol Blood Marrow Transplant. 2017;23:285–92.
pubmed: 27816651
doi: 10.1016/j.bbmt.2016.11.001
Nieto Y, Thall P, Valdez B, Andersson B, Popat U, Anderlini P, et al. High-dose infusional gemcitabine combined with busulfan and melphalan with autologous stem-cell transplantation in patients with refractory lymphoid malignancies. Biol Blood Marrow Transplant. 2012;18:1677–86.
pubmed: 22643322
pmcid: 4010147
doi: 10.1016/j.bbmt.2012.05.011
Valdez BC, Murray D, Nieto Y, Li Y, Wang G, Champlin RE, et al. Synergistic cytotoxicity of the DNA alkylating agent busulfan, nucleoside analogs and suberoylanilide hydroxamic acid in lymphoma cell lines. Leuk Lymphoma. 2012;53:973–81.
pubmed: 22023523
doi: 10.3109/10428194.2011.634043
Valdez BC, Zander AR, Song G, Murray D, Nieto Y, Li Y, et al. Synergistic cytotoxicity of gemcitabine, clofarabine and edelfosine in lymphoma cell lines. Blood Cancer J. 2014;4:e171.
pubmed: 24413065
pmcid: 3913938
doi: 10.1038/bcj.2013.69
Kebriaei P, Madden T, Kazerooni R, Wang X, Thall PF, Ledesma C, et al. Intravenous busulfan plus melphalan is a highly effective, well-tolerated preparative regimen for autologous stem cell transplantation in patients with advanced lymphoid malignancies. Biol Blood Marrow Transplant. 2011;17:412–20.
pubmed: 20674757
doi: 10.1016/j.bbmt.2010.07.016
Thall PF, Sung H-G. Some extensions and applications of a Bayesian strategy for monitoring multiple outcomes in clinical trials. Stat Med. 1998;17:1563–80.
pubmed: 9699230
doi: 10.1002/(SICI)1097-0258(19980730)17:14<1563::AID-SIM873>3.0.CO;2-L
Zhao J, Guo X, Zheng M, Su L. Meta-analysis on the efficacy of allogeneic hematopoietic stem cell transplantation to treat malignant lymphoma. Open Life Sci. 2024;19:20220771. https://doi.org/10.1515/biol-2022-0771 .
doi: 10.1515/biol-2022-0771
pubmed: 38840889
pmcid: 11151731
Diepstra A, van Imhoff GW, Karim-Kos HE, van den Berg A, te Meerman GJ, Niens M, et al. HLA class II expression by Hodgkin Reed-Sternberg cells is an independent prognostic factor in classical Hodgkin’s lymphoma. J Clin Oncol. 2007;25:3101–8.
pubmed: 17536082
doi: 10.1200/JCO.2006.10.0917
Reichel J, Chadburn A, Rubinstein PG, Giulino-Roth L, Tam W, Liu Y, et al. Flow sorting and exome sequencing reveal the oncogenome of primary Hodgkin and Reed-Sternberg cells. Blood. 2015;125:1061–72.
pubmed: 25488972
doi: 10.1182/blood-2014-11-610436
Roemer MG, Advani RH, Redd RA, Pinkus GS, Natkunam Y, Ligon AH, et al. Classical Hodgkin lymphoma with reduced β
pubmed: 27737878
pmcid: 5210180
doi: 10.1158/2326-6066.CIR-16-0201
Burroughs LM, O'donnell PV, Sandmaier BM, Storer BE, Luznik L, Symons HJ, et al. Comparison of outcomes of HLA-matched related, unrelated, or HLA-haploidentical related hematopoietic cell transplantation following nonmyeloablative conditioning for relapsed or refractory Hodgkin lymphoma. Biol Blood Marrow Transplant. 2008;14:1279–87.
pubmed: 18940683
pmcid: 2647369
doi: 10.1016/j.bbmt.2008.08.014
Martínez C, Gayoso J, Canals C, Finel H, Peggs K, Dominietto A, et al. Post-transplantation cyclophosphamide-based haploidentical transplantation as alternative to matched sibling or unrelated donor transplantation for Hodgkin lymphoma: a registry study of the Lymphoma Working Party of the European Society for Blood and Marrow Transplantation. J Clin Oncol. 2017;35:3425–32.
pubmed: 28846465
doi: 10.1200/JCO.2017.72.6869
Gauthier J, Poiré X, Gac AC, Leclerc M, Guillaume T, Chalandon Y, et al. Better outcome with haploidentical over HLA-matched related donors in patients with Hodgkin’s lymphoma undergoing allogeneic haematopoietic cell transplantation—a study by the Francophone Society of Bone Marrow Transplantation and Cellular Therapy. Bone Marrow Transplant. 2018;53:400–9.
pubmed: 29330405
doi: 10.1038/s41409-017-0018-z
Ahmed S, Kanakry JA, Ahn KW, Litovich C, Abdel-Azim H, Aljurf M, et al. Lower graft-versus-host disease and relapse risk in post-transplant cyclophosphamide-based haploidentical versus matched sibling donor reduced intensity conditioning transplant for Hodgkin lymphoma. Biol Blood Marrow Transplant. 2019;25:1859–68.
pubmed: 31132455
pmcid: 6755039
doi: 10.1016/j.bbmt.2019.05.025
Montoro J, Boumendil A, Finel H, Bramanti S, Castagna L, Blaise D, et al. Post-transplantation cyclophosphamide-based graft-versus-host disease prophylaxis in HLA-matched and haploidentical donor transplantation for patients with Hodgkin lymphoma: a comparative study of the Lymphoma Working Party of the European Society for Blood and Marrow Transplantation. Transplant Cell Ther. 2024;30:210.e1–210.e14.
pubmed: 38043802
doi: 10.1016/j.jtct.2023.11.021
Bolaños-Meade J, Hamadani M, Wu J, Al Malki MM, Martens MJ, Runaas L, et al. Post-transplantation cyclophosphamide-based graft-versus-host disease prophylaxis. N Engl J Med. 2023;388:2338–48.
pubmed: 37342922
pmcid: 10575613
doi: 10.1056/NEJMoa2215943
Broers AEC, de Jong CN, Bakunina K, Hazenberg MD, van Marwijk Kooy M, de Groot MR, et al. Posttransplant cyclophosphamide for prevention of graft-versus-host disease: results of the prospective randomized HOVON-96 trial. Blood Adv. 2022;6:3378–85.
pubmed: 35143644
pmcid: 9198908
doi: 10.1182/bloodadvances.2021005847
Popat UR, Andersson BS, Bassett R, Kawedia J, Valdez BC, Alousi AM, et al. A myeloablative fractionated busulfan conditioning regimen with post-transplant cyclophosphamide in HLA-matched and haploidentical transplantation: results of a phase II study. Haematologica. 2022;107:2496–2500.
pubmed: 35770531
pmcid: 9521225
doi: 10.3324/haematol.2022.280778
Zurko J, Ramdial J, Shadman M, Ahmed S, Szabo A, Iovino L, et al. Allogeneic transplant following CAR T-cell therapy for large B-cell lymphoma. Haematologica. 2023;108:98–108.
pubmed: 35833303
doi: 10.3324/haematol.2022.281242
Fried S, Shouval R, Walji M, Flynn JR, Yerushalmi R, Shem-Tov N, et al. Allogeneic hematopoietic cell transplantation after chimeric antigen receptor T cell therapy in large B cell lymphoma. Transplant Cell Ther. 2023;29:99–107.
pubmed: 36343892
doi: 10.1016/j.jtct.2022.10.026