Introduction . Acute leukemias are very rarely diagnosed during pregnancy, which makes large prospective or comparative studies of treatment of leukemias during pregnancy difficult. In 2009, the Russian Acute Lymphoblastic Leukemia Study Group decided to include women diagnosed with acute lymphoblastic leukemia (ALL) during various stages of pregnancy into the ALL-2009 prospective clinical study to determine the predictive role of pregnancy at diagnosis, and to estimate efficacy and tolerance of the ALL-2009 protocol in pregnant women. Materials and methods . During the period of 2009– 2017, 15 pregnant women with Ph-negative ALL aged 18–41 (median 28) years were enrolled in the multicenter clinical trial ALL-2009 (NCT number NCT01193933). Eleven women were treated at the National Research Center for Hematology in Moscow; the other four were treated in Russian regional hospitals. In cases when ALL was diagnosed during the first trimester of pregnancy (n = 3), the pregnancy was terminated. If ALL was diagnosed at week 34–40 (n = 3), the baby was delivered before the beginning of therapy. If ALL was diagnosed during the second or early third trimester, the treatment was performed during pregnancy. We compared toxicity and tolerance of chemotherapy according to the ALL-2009 protocol in pregnant patients and in young (30 years and younger) ALL patients. We also compared the results of treatment of pregnant patients with the control group (127 women of fertile age: 16–50 years old, with a median of 28 years old) enrolled in the study. For discussion of the results, we did a meta-analysis of available publications (retrieved via PubMed using the keywords “acute lymphoblastic leukemia” and “pregnancy”). Results . There was a significantly higher frequency of T-cell ALL than of B-cell ALL (53.3% vs 46,7% compared to 26% vs 69,3% in the control group, p = 0.025). Other than that, there were no significant differences in clinical or laboratory data between the groups. No significant differences were found in the duration of neutropenia, or in the duration and frequency of breaks in chemotherapy compared with other patients below 30 enrolled in the study. However, during the first remission induction phase, pregnant patients required blood transfusions, specifically platelets, at a higher rate (77.8% vs 46.6% of cases). Results of the treatment were similar regardless of pregnancy at the time of diagnosis (86.7% of complete remissions, vs 85.8% in the control group). Differences in the frequency of refractory leukemia (13.3% vs 4.7%) were not statistically significant. There were no cases of early mortality. Long-term results were also similar, both in terms of overall survival (58.6% vs 43.3% in the control group) and in terms of disease-free survival (46% vs 51%). Relapse probability was the same (49% vs 40.3%). Overall, the pregnant patients gave birth to 12 children (6 boys and 6 girls) at weeks 34–38 (median 35 weeks) of pregnancy. At the time of writing, all children are healthy and are developing in accordance with their age, which ranges from 2 years 1 month to 8 years 10 months (median 5 years and 2 months). Conclusion . The results of the study suggest that pregnancy at the time of diagnosis with ALL did not affect either the short-term or the long-term results of therapy according to the ALL-2009 protocol. The acceptable level of toxicity of the low-dose cytostatic therapy for both the mother and the child makes it possible to use the ALL-2009 protocol in treatment of pregnant patients.

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 reduce relapse rate (from 33 to 0 %).

The purpose of the paper is to present Russian experts' consolidated opinion about acute myeloid leukemia (AML) treatment in adult patients aged less than 60 years. The guidelines have been elaborated having regard to foreign publications and Russian experience, on the basis of global and Russian clinical trials to treat AML and to define indications for allogeneic bone marrow transplantation in patients during first complete remission.

The purpose of the paper is to present Russian experts' consolidated opinion about acute myeloid leukemia (AML) treatment in adult patients aged less than 60 years. The guidelines have been elaborated having regard to foreign publications and Russian experience, on the basis of global and Russian clinical trials to treat AML and to define indications for allogeneic bone marrow transplantation in patients during first complete remission.

The purpose of this trial was to evaluate the role of high doses Ara-C consolidation, maintenance chemotherapy, bone marrow transplantation (BMT) by assessing the long-term results of adult patients (pts) with acute myeloid leukemia (AML) according to AML-06.06 treatment protocol. During the period 2006-2009, 216 AML pts (except M3 and secondary AML) were included in this study. 143 of them were randomized in 2 groups. Chemotherapy consisted of conventional dose Ara-C + daunorubicin as the first induction course «7+3», High dose Ara-C + Mitoxantrone (HAM) as the second induction/consolidation course, HAM as the third course was applied if no complete remission (CR) after the first course has been achieved or High dose Ara-C (HiDAC) as the third course if CR was obtained after the first course, the fourth and the fifth courses with HiDAC, and two randomized arms of maintenance: «5+2» (AraC + Mercaptopurine) versus stop chemotherapy (randomization was performed before the treatment start). BMT was performed after 3, or 4, or 5 consolidation courses (26 AlloBMT, 10 AutoBMT). CR was obtained in 155 pts (72 %). If CR was obtained during the first 60 days of treatment then 5-year leukemia-free survival (LFS) was 38 %, if later 18 % (p = 0,0244). OS was similar. 5-year LFS in cytogenetic low and intermediate risk groups was 37 %, and in high risk groups 8 % (p = 0,0044). In cytogenetic low risk group 5-year overall survival was 100 % in inv(16) pts and 20 % in t(8;21) pts (p = 0736). If lactate dehydrogenase (LDH) activity was 1500 U/l and higher, 5-year LFS was 8 %, if lower 23 %, p = 0,0011). 5-year LFS in AutoBMT pts was 40 %, in AlloBMT pts 32 %, in chemotherapy pts 25 % (p = 0,4464). Relapse probability was 83 % in no-maintenance randomization group and 50 % in maintenance group (p = 0,0667). Dose intensification and maintenance chemotherapy have shown high antileukemic efficacy in limited groups of AML pts (low LDH, inv(16), WBC < 40 x 10 9/l). High LDH activity at the diagnosis, high risk cytogenetic group should be managed with other treatment approaches. Introducing BMT technologies may provide some benefit in some groups of AML pts. We have to emphasize that there were some differences in the results in t(8;21) pts comparing with published data.

The aim of this study was to evaluate the results of combined application of tyrosine kinase inhibitors and chemotherapy in patients with Philadelphia chromosomepositive acute lymphoblastic leukemia. In this study, except Hematological Research Center in Moscow, participated 5 more hematological centers (Saint-Petersburg, Tula, Nizhny Novgorod, Irkutsk, Surgut). Results of the induction and postremission therapy proved to be very optimistic. However, there was a high toxicity and low reproducibility of treatment program that formed the basis for creating a new protocol of treatment for patients with Philadelphia chromosome-positive acute lymphoblastic leukemia in different age groups.