• E N Parovichnikova, L A Kuzmina, L P Mendeleeva, G A Klyasova, V V Troitskaya, A N Sokolov, Z Kh Akhmerzaeva, S K Kravchenko, E O Gribanova, E E Zvonkov, S N Bondarenko, O Yu Baranova, T V Ryltsova, L V Gavrilova, E E Zinina, A S Pristupa, T S Kaporskaya, N V Minaeva, O S Samoilova, T S Konstantinova, V A Lapin, K D Kaplanov, I V Kryuchkova, A S Nizamutdinova, A V Klimovich, E A Borisenkova, V I Moskov, T V Gaponova, T V Obukhova, I V Galtseva, M A Rusinov, S M Kulikov, and V G Savchenko.
• Hematology Research Center, Ministry of Health of Russia, Moscow, Russia.
• Terapevt Arkh. 2015 Jan 1; 87 (7): 15-25.

AimTo analyze the efficiency of the ALL-2009 protocol (ClinicalTrials.gov NCT01 193933) in patients with T-cell leukemias, particularly the role of autologous hematopoietic stem cell transplantation (auto-HSCT) after non-myeloablative BEAM conditioning, followed by maintenance therapy.Subjects And MethodsSince 2009, the ALL-2009 study has enrolled 90 patients with T-cell acute lymphoblastic leukemia (T-ALL), the treatment results were assessed in 86 patients: 6 and 28 patients underwent allogeneic HSCT and auto-HSCT, respectively. A landmark analysis was used to compare survival rates in patients who had undergone auto-HSCT and in those who had not. For this, the median time from complete remission to the date of auto-HSCT was determined (the median was 6 months). Then to compare with the auto-HSCT group, only 27 patients who had been in complete remission for 6 months or more were included in a chemotherapy group.ResultsThe achievement of complete remission in patients with thymic T-ALL (100%) was significantly higher than in those with early (85.7%) or mature (70%) variants. The patients with early and mature T-ALL as compared to those with thymic T-ALL showed high death rates in the remission induction (7.4 and 10% versus 0) and the patients with mature T-ALL had a.higher proportion of refractory forms (20% versus 0). The 5-year overall and relapse-free survival rates in all the T-ALL patients were 66 and 76%, respectively. After auto-HSCT, the risk of recurrence was 0% versus 21% after chemotherapy (p=0.03). The relapse-free survival rates significantly differed in the auto-HSCT and non-auto-HSCT groups: 100 and 66%, respectively (p=0.047).ConclusionThe long-term survival rates obtained during this multicenter study in the T-ALL patients treated according to the ALL-2009 protocol, the basis for which is the principle of continuity of cytostatic effects, are exclusively optimistic. Late consolidation with auto-HSCT following non-myeloablative BEAM conditioning, followed by maintenance therapy, considerably reduces the risk of recurrence.

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