ISSN 1866-8836
Клеточная терапия и трансплантация

AL-01. The role of allogeneic hematopoietic stem cell transplantation in adult patients with Ph-negative lymphoblastic leukemia due to the high risk of recurrence in a prospective multicentre randomized study RALL-2016

Olga A. Aleshina1, Ekaterina S. Kotova1, Irina V. Galtseva1, Tatiana N. Obukhova1, Valentina N. Dvirnyk1, Andrey B. Sudarikov1, Galina A. Isinova1, Anastasia N. Vasilyeva1, Maria E. Grishunina2, Olga S. Samoilova2, Kamil D. Kaplanov3, Valeriy A. Lapin4, Sergey N. Bondarenko5, Natalia V. Minaeva6, Yulia V. Sveshnikova7, Elena E. Zinina8, Alina S. Antipova9, Olga Yu. Baranova9, Elena A. Borisenkova10, Yulia A. Chabaeva1, Sergey M. Kulikov1, Elena N. Parovichnikova1

1 National Medical Research Center for Hematology, Moscow, Russia
2 N. A. Semashko Nizhny Novgorod Regional Clinical Hospital, Nizhny Novgorod, Russia
3 S. P. Botkin City Clinical Hospital, Moscow
4 Regional Clinical Hospital, Yaroslavl, Russia
5 RM Gorbacheva Research Institute, Pavlov University, St. Petersburg, Russia
6 Kirov Research Institute of Hematology and Blood Transfusion, Kirov, Russia
7 Regional Hematology Center, Sverdlovsk Regional Clinical Hospital No.1, Yekaterinburg, Russia
8 Surgut Regional Clinical Hospital, Surgut, Russia
9 N. N. Blokhin Russian Cancer Research Center, Moscow, Russia
10 Kaluga Regional Hospital, Kaluga, Russia

Contact: Dr. Olga A. Aleshina, e-mail:

doi 10.18620/ctt-1866-8836-2023-12-3-1-176


According to the protocol RALL-2016 study, to the high-risk group for diseases in adult ALL patients with ETP-ALL, with 11q23 rearrangements, with t(1;19) translocation in B-ALL, and patients with Nijmegen syndrome. All patients in this group are characterized by an extremely high risk of relapse in the first 12 months of therapy and relapse-free survival with low sensitivity to ALL. Only for this group of patients, allo-HSCT was detected in the first achievement of remission, regardless of the rate of MRD-negative status. Our aim was to evaluate the expected results and the significance of performing allo-HSCT in complete remission (1CR) for patients with high-risk ALL who received therapy in the prospective multicenter randomized study “ALL-2016”.

Patients and methods

The ALL-2016 study performed since December 2016 to February 2023, included 266 patients with Ph-negative ALL. According to the criteria, 37 (14%) patients were assigned to the high-risk group. Of these cases, 15 (41%) patients were diagnosed with B-ALL, 22 (59%) patients had T-ALL. Clinical characteristics of patients: median age was 31.6 years (18-53 years), m/f=25/12 (68%/32%), hyperleukocytosis, in 4(11%) patients. Two (5%) suffered with Nijmegen syndrome, 12(33%) had 11q23 rearrangements, 6 (16%) exhibited t(1;19), 17(46%) had ETP-ALL. All patients achieving remission underwent a donor search and planned allo-HSCT. Statistical data processing was carried out using SAS software.


Early mortality was 5.4% (2 out of 37 patients), refractory was detect in 5.4% (2 patients). The frequency of achieving complete hematological remission during the first 70 days reaches 89.2%. In 50% of patients who reached 1CR, MRD persisted on the 70th day of the protocol according to FCM. The five-year OS was 40%. Allo-HSCT in 1 CR were achieved 15 (45%) patients. The median of achievement allo-HSCT was 174 days (118-372 days), most patients were completed within 5 months of achieving remission. Significant diseases in the 5-year RFS in the allo-HSCT and without allo-HSCT groups were not obtained, however, the dynamics are obvious: for the allo-HSCT group was 76%, and for the group without allo-HSCT – 42% (p=0.222).


Data on early mortality, refractory and frequency of 1CR achievements in the high-risk group were obtained. This study demonstrated an increase in long-term outcome in the high-risk ALL recurrence group with allo-HSCT, which dictates its obligatory implementation in 1CR at an earlier time of relapse.


Acute lymphoblastic leukemia, high-risk group, allogeneic hematopoietic stem cell transplantation, Nijmegen syndrome, 11q23, t(1;19), ETP-ALL.

Supplement 12-3

Download PDF version

doi 10.18620/ctt-1866-8836-2023-12-3-1-176

Back to the list