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Background. The effectiveness of therapy for acute T-lymphoblastic leukemia (T-ALL) and T-lymphoblastic lymphoma (T-LBL) has significantly improved over the past decades, including through the implementation of hematopoietic stem cell transplantation (HSCT). The Russian multicenter ALL-2009 study (ClinicalTrials.gov NCT01193933) showed that performing autologous HSCT (auto-HSCT) in patients with T-ALL/LBL improves long-term results. However, the study was non-randomized and the need for auto-HSCT in clinical practice requires careful study.Aim. To assess the significance of auto-HSCT in patients with T-ALL/LBL in the framework of ALL-2016 multicenter, prospective, randomized study (ClinicalTrials.gov NCT03462095).Materials and methods. The study included 109 adult patients with T-ALL/LBL (m:f 82:27). Median age was 31 (18– 52) years. T-ALL was diagnosed in 88 (81 %) patients, T-LBL in 21 (19 %) patients. All patients are treated according to the ALL-2016 protocol. Using the web platform, upon completion of induction therapy (+70 days), all T-ALL/LBL patients who achieved clinical and hematological remission were randomized to the auto-HSCT arm or chemotherapy alone (CT). Centralized monitoring of minimal residual disease (MRD) in bone marrow samples was performed by multicolor flow cytometry at the control points according to the ALL-2016 protocol. Statistical analysis was performed using SAS 9.4.Results. 87 patients with T-ALL/LBL were randomized: 44 to the auto-HSCT arm and 43 to the CT arm. Further analysis included 25 patients who underwent auto-HSCT and 36 patients receiving only CT. Three-year relapse-free survival in T-ALL is estimated at 62 % (auto-HSCT) vs. 81 % (CT) (p = 0.3422), and in T-LBL – 67 % (auto-HSCT) vs. 79 % (CT) (p = 0.59). MRD persistence on the +70th day of therapy according to the ALL-2016 protocol was determined in 40 % of patients (autoHSCT) and in 67 % (CT) (p = 0.057). In a multivariate analysis, it was determined that T-ALL from early T-cell precursor (ETP-variant) and MRD persistence after the end of II phase induction are the main risk factors for relapse in the treatment according to the ALL-2016 protocol.Conclusion. Performing auto-HSCT both in patients with T-ALL and T-LBL, and with MRD persistence on day +70 according to the ALL-2016 protocol did not improve long-term results. The development of new programs for the treatment of patients with MRD persistence, as well as the ETP variant of T-ALL, is of current interest.

Russian Interregional Register of hematopoietic stem cell transplantation was established in 2000. 11 transplant centres from 7 Russian cities are including in Register now. In this analysis we applied transplant activity survey data from 01.01.1996 to 31.12.2006. A total 1118 transplants (846 – autologous and 272 – allogeneic) were carried during this period.

An interim analysis of long-term treatment results for 202 patients with acute lymphoblastic leukemia (ALL), aged 15–60 years, received therapy according protocol ALL-2009 was shown. The basic principle of ALL-2009 was non-aggressive, but continued cytostatic exposure, as well as the reproducibility in a regional hematology centers. Long-term treatment results of ALL-2009 are 2 times higher than the previously obtained in adult ALL patients within the Russian clinical multicenter studies of adult ALL. The 5‑year overall survival of patients younger than 30 years was 73.6 %, relapse-free survival (RFS) – 71.5 %, compared with 52.7 % and 61.8 % in patients aged 30 years and older, respectively. In patients with B-precursor ALL with normal karyotype of blast cells significantly higher 5‑year RFS (82.1 %) compared to patients with abnormal karyotype (58.8 %) was registered. For T-ALL cytogenetic characteristics of blast cells had no prognostic significance. For patients with T-ALL important to perform autologous stem cell transplantation as a later consolidation, as this significantly reducerelapse rate (from 33 to 0 %).