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Clinical Trial
. 2021 May 13;137(19):2646-2656.
doi: 10.1182/blood.2020008825.

A randomized phase 3 trial of autologous vs allogeneic transplantation as part of first-line therapy in poor-risk peripheral T-NHL

Norbert Schmitz  1 , Lorenz Truemper  2 , Krimo Bouabdallah  3 , Marita Ziepert  4 , Mathieu Leclerc  5 , Guillaume Cartron  6 , Arnaud Jaccard  7 , Peter Reimer  8 , Eva Wagner  9 , Martin Wilhelm  10 , Laurence Sanhes  11 , Thierry Lamy  12 , Laurence de Leval  13 , Andreas Rosenwald  14   15 , Muriel Roussel  16 , Frank Kroschinsky  17 , Walter Lindemann  18 , Peter Dreger  19 , Andreas Viardot  20 , Noël Milpied  3 , Christian Gisselbrecht  21 , Gerald Wulf  2 , Emmanuel Gyan  22 , Philippe Gaulard  23 , Jacques Olivier Bay  24 , Bertram Glass  25 , Viola Poeschel  26 , Gandhi Damaj  27 , David Sibon  28 , Alain Delmer  29 , Karin Bilger  30 , Anne Banos  31 , Mathias Haenel  32 , Martin Dreyling  33 , Bernd Metzner  34 , Ulrich Keller  35 , Friederike Braulke  2 , Birte Friedrichs  1 , Maike Nickelsen  36 , Bettina Altmann  4 , Olivier Tournilhac  37
Affiliations
Clinical Trial

A randomized phase 3 trial of autologous vs allogeneic transplantation as part of first-line therapy in poor-risk peripheral T-NHL

Norbert Schmitz et al. Blood. .

Abstract

First-line therapy for younger patients with peripheral T-cell non-Hodgkin lymphoma (T-NHL) consists of 6 courses of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) with or without etoposide (CHOEP), consolidated by high-dose therapy and autologous stem cell transplantation (auto-SCT). We hypothesized that allogeneic stem cell transplantation (allo-SCT) could improve outcomes. 104 patients with peripheral T-cell non-Hodgkin lymphoma, except ALK+ anaplastic large cell lymphoma, 18 to 60 years, all stages, and all age adjusted International Prognostic Index scores, except 0 and stage I, were randomized to 4 cycles of CHOEP and 1 cycle of dexamethasone, cytosine-arabinoside, and platinum (DHAP) followed by high-dose therapy and auto-SCT or myeloablative conditioning and allo-SCT. The primary end point was event-free survival (EFS) at 3 years. After a median follow-up of 42 months, the 3-year EFS after allo-SCT was 43%, as compared with 38% after auto-SCT. Overall survival at 3 years was 57% vs 70% after allo- or auto-SCT, without significant differences between treatment arms. None of the 21 responding patients proceeding to allo-SCT relapsed, as opposed to 13 of 36 patients (36%) proceeding to auto-SCT. Eight of 26 patients (31%) and none of 41 patients died of transplant-related toxicity after allo- and auto-SCT, respectively. The strong graft-versus-lymphoma effect after allo-SCT was counterbalanced by transplant-related mortality. This trial is registered at www.clinicaltrials.gov as #NCT00984412.

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Figures

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Graphical abstract
Figure 1.
Figure 1.
CONSORT diagram. no PTCL, no PTCL according to reference pathology.
Figure 2.
Figure 2.
Outcome according to treatment arm. Event-free (A,D), progression-free (B,E), and overall survival (C,F) for all randomized patients (intent-to-treat population) (A-C) and for transplant recipients only (D-F).
Figure 3.
Figure 3.
Relapse and mortality. Cumulative incidence for relapse (A) and nonrelapse mortality (B).
See this image and copyright information in PMC

Comment in

References

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