De-escalated Treatment Approach for Adult Ph-negative Acute Lymphoblastic Leukemia (ALL)

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Brief summary

No high-dose methotrexate (MTX) and high-dose cytarabine (ARA-C) consolidation blocks, L-asparaginaseis scheduled for 1 year of treatment, 21 intrathecal injections through the whole treament, T-ALL patients in complete remossion (CR) after the informed consent are randomized to: auto-HSCT vs no auto-HSCT, - with the similar further maintenance. Stem cell harvest is performed after the 3rd consolidation by G-SCF disregarding minimal residual disease (MRD) level. Auto-HSCT is planned after the 5th consolidation phase. All primary bone samples are collected and tested for cytogenetics and molecular markers, all included patients are monitored by flow cytometry by aberrant immunophenotype in a centralized lab.

Detailed description

* 7 days prednisolone prephase * 8 weeks induction with de-escalation of induction chemotherapy: 3 instead of 4 dauno/vncr pulses, 1. instead of 2 Cph injections during induction, 2. instead of 4 ARA-C blocks, distribution of of L-asp injections through all phases * After CR achievement T-cell ALL patients are being randomized to auto-HSCT vs no auto-HSCT * Non-interruptive 5 consolidation phases with dose modification according to WBC and platelets count after CR achievement. Rotation of consolidation is permitted * After the 3rd consolidation stem cells harvesting is carried out for T-cell ALL patients randomized to auto-HSCT * Auto-HSCT after the 5th consolidation phase with non-myeloablative CEAM conditioning * 2 years maintenance for all patients * 21 TIT through the whole treatment with higher intensity during induction\|consolidation * Centralized MRD monitoring at +70 d, + 133 d, + 190 days; before and after auto-HSCT * Allo-HSCT is planned only for very high risk patients (11q23 ALL, MRD positivity at day +190)

Olga A. Aleshina, E. S. Kotova, I. V. Galtseva, Yu. A. Chabaeva, V. N. Dvirnyk et al. (6 authors)

Oncohematology2025-12-10

10.17650/1818-8346-2025-20-4-32-40

P396: FIFTEEN YEARS OF RUSSIAN RESEARCH IN THE TREATMENT OF ADULT PATIENTS WITH ACUTE PH-NEGATIVE LYMPHOBLASTIC LEUKEMIA ACCORDING TO THE PROTOCOLS ALL-2009 AND ALL-2016.

Olga Aleshina, V. V. Troitskaya, Irina Galtseva, Ekaterina Kotova, Galina Isinova et al. (25 authors)

HemaSphere2023-08-01

10.1097/01.hs9.0000968492.27396.d8

Treatment outcomes for acute T-lymphoblastic leukemias/lymphomas: data from the ALL-2016 multicenter prospective randomized trial

O. A. Aleshina, Irina Galtseva, Ekaterina Kotova, G. I. Isinova, Т. Н. Обухова et al. (26 authors)

Oncohematology2023-03-133 citations

10.17650/1818-8346-2023-18-1-20-30

Immunophenotype of Measurable Residual Blast Cells as an Additional Prognostic Factor in Adults with B-Cell Acute Lymphoblastic Leukemia

Yulia Davydova, Irina Galtseva, Н. М. Капранов, К. А. Никифорова, Olga Aleshina et al. (12 authors)

Diagnostics2022-12-214 citations

10.3390/diagnostics13010021

Polymorphisms of the <i>TPMT</i>, <i>NUDT15</i> genes and 6-mercaptopurine toxicity profile in adult patients with Ph-negative acute lymphoblastic leukemia/lymphomas on the ALL-2016 protocol

Ekaterina Kotova, Olga A. Gavrilina, Igor Yakutik, Andrey Sudarikov, Yulia Chabaeva et al. (17 authors)

Oncohematology2022-07-20

10.17650/1818-8346-2022-17-3-98-107

Clinical Exome Sequencing in B-Cell Ph-Negative ALL Patient Demonstrates Clonal Changes at Different Stages of the Disease

Ksenija I. Zarubina, Е. Н. Паровичникова, В. Л. Сурин, O. S. Pshenichnikova, E. Yu. Demidova et al. (13 authors)

Blood2020-11-05

10.1182/blood-2020-136041

Interim Results of Russian Acute Lymphoblastic Leukemia (RALL-2016) Study with Centralized MRD-Monitoring and Randomization for Autologous HSCT with Non-Myeloablative Conditioning in Adult Ph-Negative ALL Patients

Olga A. Gavrilina, Е. Н. Паровичникова, V. V. Troitskaya, Irina Galtseva, Galina Baskhaeva et al. (22 authors)

Blood2019-11-13

10.1182/blood-2019-124701

MRD Status Did Not Correspond to the Relapse Incidence within One Year of Follow-up By Non-Intensive but Non-Interruptive Approach: The First Interim Results of the Russian Prospective Multicenter RALL-2016 Trial for Ph-Negative Adult ALL

Olga A. Gavrilina, Е. Н. Паровичникова, V. V. Troitskaya, Galina Baskhaeva, А Н Соколов et al. (21 authors)

Blood2018-11-29

10.1182/blood-2018-99-116318

Interventions

PROCEDUREAutologous HSCT

After the 3rd consolidation, T-cell ALL patients, randomized to auto-HSCT will be mobilised by G-SCF and harvested disregarding MRD-status. After completing the 5th consolidation T-ALL patients will be transplanted after non-myeloablative CEAM (CCNU, Ethoposide, ARA-C, Melphalan) conditioning, and after reconstitution will continue 2-years maintenance

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

No

Inclusion criteria

* age 18-55 yy, newly diagnosed non-treated Ph-negative ALL

Exclusion criteria

* age \> 55 yy, Ph-positivity, relapsed\|refractory ALL, pretreated ALL

Design outcomes

Primary

Measure	Time frame	Description
Disease-free survival	5-years	Impact of autologous HSCT on DFS in T-cell ALL patients

Secondary

Measure	Time frame	Description
MRD-negativity after consolidation	6 months	Minimal Residual Disease clearance on non-intensive but non-interruptive treatment
Overall survival	5-years	Impact of de-escalated approach on OS

Countries

Russia

Contacts

Primary ContactElena N Parovichnikova, MD,PhD

elenap@blood.ru+79161252623

Backup ContactOlga A Gavrilina, M.D.

dr.gavrilina@mail.ru

Outcome results

None listed