• Adèle de Masson, Marie Beylot-Barry, Caroline Ram-Wolff, Jean-Baptiste Mear, Stéphane Dalle, Michel d'Incan, Saskia Ingen-Housz-Oro, Corentin Orvain, Julie Abraham, Olivier Dereure, Amandine Charbonnier, Jérôme Cornillon, Christine Longvert, Stéphane Barete, Serge Boulinguez, Ewa Wierzbicka-Hainaut, François Aubin, Marie-Thérèse Rubio, Marc Bernard, Aline Schmidt-Tanguy, Roch Houot, Anne Pham-Ledard, David Michonneau, Pauline Brice, Hélène Labussière-Wallet, Jean-David Bouaziz, Florent Grange, Hélène Moins-Teisserenc, Katayoun Jondeau, Laurence Michel, Samia Mourah, Maxime Battistella, Etienne Daguindau, Michael Loschi, Alexandra Picard, Nathalie Franck, Natacha Maillard, Anne Huynh, Stéphanie Nguyen, Ambroise Marçais, Guillaume Chaby, Patrice Ceballos, Yannick Le Corre, Sébastien Maury, Jacques-Olivier Bay, Henri Adamski, Emmanuel Bachy, Edouard Forcade, Gérard Socié, Martine Bagot, Sylvie Chevret, Régis Peffault de Latour, CUTALLO Investigators, Groupe Français d'Etude des Lymphomes Cutanés, and Société Française de Greffe de Moëlle et Thérapie Cellulaire.
• Department of Dermatology, Saint-Louis Hospital, Assistance Publique-Hôpitaux de Paris, Paris, France; Institut National de la Santé et de la Recherche Médicale U976 Human Immunology, Pathophysiology and Immunotherapy, Institut de Recherche Saint-Louis, Paris, France; Université Paris Cité, Paris, France. Electronic address: adele.demasson@aphp.fr.
• Lancet. 2023 Jun 10; 401 (10392): 194119501941-1950.

BackgroundAdvanced-stage cutaneous T-cell lymphomas (CTCLs) are rare, usually refractory, and fatal diseases. Case series have suggested that allogeneic haematopoietic stem cell transplantation (HSCT) might improve the prognosis of advanced-stage CTCLs. The objective of this study was to investigate the effect of allogeneic HSCT compared with non-HSCT therapy on the outcome of individuals with advanced-stage CTCLs.MethodsIn this prospective, multicentre, matched controlled trial, conducted at 30 hospitals, participants with advanced CTCLs were allocated treatment: if they had an available compatible related donor they were assigned to allogeneic HSCT, or if not they were allocated to non-allogeneic HSCT therapy. Key inclusion criteria were participants aged 18-70 years, with advanced stage mycosis fungoides or Sézary syndrome, and at least one poor prognostic criteria. Participants were excluded if they were not in complete or partial remission of the disease. Propensity score 1:1 matching with replacement (ie, that each participant treated with HSCT was matched to the participant with the closest propensity score treated with non-HSCT therapy, even if they had already been matched) was used to handle confounding factors, with the balance of covariate distribution between HSCT and non-HSCT groups assessed using standardised mean differences. The primary endpoint was progression-free survival in the matched intention-to-treat population. This trial is registered with ClinicalTrials.gov (NCT02520908), and is currently active but not recruiting.FindingsFrom June 1, 2016, to March 3, 2022, total of 99 participants were enrolled at 17 centres in France. Participants with a sibling or matched unrelated donor were assigned to allogeneic HSCT (HSCT group, n=55 [56%]) and participants without a donor were assigned to non-allogeneic HSCT treatment (non-HSCT group, n=44 [44%]). The median follow-up among survivors was 12·6 months (IQR 11·0-35·2). In the HSCT group, 51 participants (93%) were 1:1 matched to participants from the non-HSCT group. In the intention-to-treat analysis, median progression-free survival was significantly longer in the HSCT group (9·0 months [95% CI 6·6-30·5]) than in the non-HSCT group (3·0 months [2·0-6·3]), with a hazard ratio of 0·38 (95% CI 0·21-0·69; p<0·0001). In the per-protocol population, 40 participants (78%) in the HSCT group had 101 serious events and 29 participants (67%) in the non-HSCT group had 70 serious adverse events. The most common serious adverse event other than graft-versus-host disease in both groups was infections, occurring in 30 participants (59%) in the HSCT group and in 19 participants (44%) in the non-HSCT group.InterpretationAllogeneic HSCT was associated with significantly longer progression-free survival in participants with advanced-stage CTCLs. These results indicate that allogeneic HSCT treatment should be made available to individuals with high-risk, advanced-stage mycosis fungoides or Sézary syndrome who achieve pre-transplant disease remission.FundingFrench Ministry of Health, National Cancer Institute, Programme Hospitalier de Recherche Clinique en Cancérologie.Copyright © 2023 Elsevier Ltd. All rights reserved.

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