EHA Library - The official digital education library of European Hematology Association (EHA)

TWO CONSECUTIVE MULTICENTER RUSSIAN ACUTE LYMPHOBLASTIC LEUKEMIA (RALL) STUDIES IN PH-NEGATIVE ADULT ALL: SUCCESSES AND PITFALLS
Author(s): ,
Elena Parovichnikova
Affiliations:
Department of Chemotherapy of Hemoblastosis, Depression of Hematopoiesis and BMT,National Research Center for Hematology,Moscow,Russian Federation
,
Olga Gavrilina
Affiliations:
Departament of Chemotherapy of hemoblastosis,National Research Center for Hematology,Moscow,Russian Federation
,
Vera Troitskaya
Affiliations:
Departament of Chemotherapy of hemoblastosis,National Research Center for Hematology,Moscow,Russian Federation
,
Yulia Chabaeva
Affiliations:
Medical Statistics,National Research Center for Hematology,Moscow,Russian Federation
,
Irina Galtseva
Affiliations:
Immunophenotyping Laboratory,National Research Center for Hematology,Moscow,Russian Federation
,
Julia Davydova
Affiliations:
Immunophenotyping Laboratory,National Research Center for Hematology,Moscow,Russian Federation
,
Andrey Sokolov
Affiliations:
Departament of Chemotherapy of hemoblastosis,National Research Center for Hematology,Moscow,Russian Federation
,
Zalina Akhmerzaeva
Affiliations:
Outpatient department,National Research Center for Hematology,Moscow,Russian Federation
,
Kseniya Zarubina
Affiliations:
Departament of Chemotherapy of hemoblastosis,National Research Center for Hematology,Moscow,Russian Federation
,
Galina Isinova
Affiliations:
Departament of Chemotherapy of hemoblastosis,National Research Center for Hematology,Moscow,Russian Federation
,
Larisa Kuzmina
Affiliations:
Department of Bone Marrow Transplantation,National Research Center for Hematology,Moscow,Russian Federation
,
Mikhail Drokov
Affiliations:
Department of Bone Marrow Transplantation,National Research Center for Hematology,Moscow,Russian Federation
,
Elena Gribanova
Affiliations:
Departament of Chemotherapy for hematological diseases,National Research Center for Hematology,Moscow,Russian Federation
,
Evgeny Zvonkov
Affiliations:
Departament of Chemotherapy of lymphomas,National Research Center for Hematology,Moscow,Russian Federation
,
Sergey Bondarenko
Affiliations:
Department of Oncology, Hematology and Transplantology,Raisa Gorbacheva Memorial Research Institute for Pediatric Oncology, Hematology and Transplantation of the Pavlov First Saint Petersburg State Medical University, St. Petersburg,Russian Federation
,
Olga Baranova
Affiliations:
Department of bone marrow transplantation,N.N. Blokhin National Medical Research Center of Oncology,Moscow,Russian Federation
,
Mariya Grishunina
Affiliations:
Hematology department,Nizhny Novgorod Regional Clinical Hospital named after N.A. Semashko,Nizhny Novgorod,Russian Federation
,
Kamil Kaplanov
Affiliations:
Hematology department,City Clinical Hospital named after S.P. Botkin,Moscow,Russian Federation
,
Elena Zinina
Affiliations:
Hematology department,Surgut Regional Clinical Hospital,Surgut,Russian Federation
,
Tatiyana Konstantinova
Affiliations:
Hematology department,Sverdlovsk Regional Clinical Hospital No. 1,Ekaterinburg,Russian Federation
,
Elena Borisenkova
Affiliations:
Hematology department,Kaluga regional hospital,Kaluga,Russian Federation
,
Valery Lapin
Affiliations:
Hematology department,Yaroslavl Regional Clinical Oncological Hospital,Yaroslavl,Russian Federation
,
Tatiyana Obukhova
Affiliations:
Laboratory of karyology,National Research Center for Hematology,Moscow,Russian Federation
,
Sergey Kulikov
Affiliations:
Medical Statistics,National Research Center for Hematology,Moscow,Russian Federation
Valery Savchenko
Affiliations:
Head of National Research Center for Hematology,National Research Center for Hematology,Moscow,Russian Federation
EHA Library. Parovichnikova E. 06/09/21; 325114; EP360
Elena Parovichnikova
Elena Parovichnikova
Contributions
Abstract
Presentation during EHA2021: All e-poster presentations will be made available as of Friday, June 11, 2021 (09:00 CEST) and will be accessible for on-demand viewing until August 15, 2021 on the Virtual Congress platform.

Abstract: EP360

Type: E-Poster Presentation

Session title: Acute lymphoblastic leukemia - Clinical

Background
Since 2009 RALL-study group has conducted two clinical multicenter trials on the treatment of adult patients with Ph-negative ALL. The majority of adult ALL studies are highly intensive with substantial numbers of allogeneic HSCT in 1CR and tailor their treatment according to MRD levels after the induction phase. RALL studies were based on the non-intensive, but non-interruptive approach without high dose consolidations and without many allo-HSCTs but with autologous HSCT for T-cell ALL as late consolidation. Pregnant women were included in both trials. MRD measurement was carried out only in the second RALL-2016 study.

Aims
to present the comparison of long-term results of both studies and evaluate the impact of MRD measurement in RALL-2016.

Methods
From Jan, 2009, till Dec, 2016, 30 centers had enrolled 330 and since Dec 2016 till Jan 2021, 10 centers included 207 acute Ph-negative lymphoblastic leukemia patients. The main trials characteristics are presented in Table 1. There were no difference between two trials in numbers of autologous HSCTs for T-ALL (42/125 (33%) pts in RALL-2009 and 23/85 (27%) in RALL-2016); no difference in numbers of allo-HSCTs in 1CR (19/281 (6,8%) in RALL-2009 and 19/170 (11,2%) in RALL-2016). But the total number of allo-HSCTs was somewhat higher in RALL-2016: 21/305 (6,9%) in RALL-2009 and 25/186 (13,5%), p=0,02). 

Results
Two trials look quite similar in main characteristics, though pts in RALL-2016 were older. Both trials have demonstrated identical stable results with optimistic long-term outcome (Pic.1. A,B). High early death rate (~10%) remains an obstacle that decreases CR rate and overall survival especially in Regional centers. MRD-positivity discriminated BCP-ALL patients at day+70 (Pic.1C) and T-ALL patients at day +133 (Pic.1D) to a poor prognostic group.

Conclusion
It was shown that disregard the absence of high-dose consolidations with high-dose methotrexate/ARA-C and low numbers of allo-HSCT in 1CR, both trials had demonstrated stable, high and reproducible results regarding overall and disease-free survival. In our setting MRD-positivity at day+70 for BCP-ALL and at day 133+ for T-ALL  identifies patients that need different approach aimed to early MRD treatment with targeting drugs followed by allo-HSCT.

Keyword(s): Acute lymphoblastic leukemia

Presentation during EHA2021: All e-poster presentations will be made available as of Friday, June 11, 2021 (09:00 CEST) and will be accessible for on-demand viewing until August 15, 2021 on the Virtual Congress platform.

Abstract: EP360

Type: E-Poster Presentation

Session title: Acute lymphoblastic leukemia - Clinical

Background
Since 2009 RALL-study group has conducted two clinical multicenter trials on the treatment of adult patients with Ph-negative ALL. The majority of adult ALL studies are highly intensive with substantial numbers of allogeneic HSCT in 1CR and tailor their treatment according to MRD levels after the induction phase. RALL studies were based on the non-intensive, but non-interruptive approach without high dose consolidations and without many allo-HSCTs but with autologous HSCT for T-cell ALL as late consolidation. Pregnant women were included in both trials. MRD measurement was carried out only in the second RALL-2016 study.

Aims
to present the comparison of long-term results of both studies and evaluate the impact of MRD measurement in RALL-2016.

Methods
From Jan, 2009, till Dec, 2016, 30 centers had enrolled 330 and since Dec 2016 till Jan 2021, 10 centers included 207 acute Ph-negative lymphoblastic leukemia patients. The main trials characteristics are presented in Table 1. There were no difference between two trials in numbers of autologous HSCTs for T-ALL (42/125 (33%) pts in RALL-2009 and 23/85 (27%) in RALL-2016); no difference in numbers of allo-HSCTs in 1CR (19/281 (6,8%) in RALL-2009 and 19/170 (11,2%) in RALL-2016). But the total number of allo-HSCTs was somewhat higher in RALL-2016: 21/305 (6,9%) in RALL-2009 and 25/186 (13,5%), p=0,02). 

Results
Two trials look quite similar in main characteristics, though pts in RALL-2016 were older. Both trials have demonstrated identical stable results with optimistic long-term outcome (Pic.1. A,B). High early death rate (~10%) remains an obstacle that decreases CR rate and overall survival especially in Regional centers. MRD-positivity discriminated BCP-ALL patients at day+70 (Pic.1C) and T-ALL patients at day +133 (Pic.1D) to a poor prognostic group.

Conclusion
It was shown that disregard the absence of high-dose consolidations with high-dose methotrexate/ARA-C and low numbers of allo-HSCT in 1CR, both trials had demonstrated stable, high and reproducible results regarding overall and disease-free survival. In our setting MRD-positivity at day+70 for BCP-ALL and at day 133+ for T-ALL  identifies patients that need different approach aimed to early MRD treatment with targeting drugs followed by allo-HSCT.

Keyword(s): Acute lymphoblastic leukemia

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