Multicenter Clinical Trial for Adult Ph-negative ALL. Non-intensive But Non-iterruptive Treatment

Conditions

Ph-negative Adult Acute Lymphoblastic Leukemia

Keywords

adult ALL, Ph-negative, dexamethasone, L-asparaginase

Brief summary

1. evaluation of blast clearance in b/m after 7 days of prednisolone prephase and the efficacy of its substitution by dexamethasone if blast count is 25% and more 2. feasibility for adults of no interruptions protocol with 8 weeks induction and 14 weeks consolidation followed by 2-years maintenance. 3. tolerability and efficacy in adults of the prolonged L-asparaginase application (total proposed dose 560.000 IU) 4. feasibility and efficacy of autologous stem cell transplantation for T-cell ALL

Detailed description

1. The blast count in b/m after 7 days of prednisolone \>25% was shown in 64% of patients. The substitution of prednisolone by dexamethasone did not influence survival. 2. no interruptions induction was performed in 48% of patients. 3. In 19% of patients the L-asparaginase therapy was stopped due to toxicity. 4. Autologous stem cell transplantation was done in 20% of T-cell ALL patients.

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

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

Лечение острых лим-фобластных лейкозов у беременных по протоколу ОЛЛ-2009

В В Троицкая, Е. Н. Паровичникова, А Н Соколов, Alina Kokhno, Г М Галстян et al. (19 authors)

2019-06-21

10.25837/hat.2019.92.27.001

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

Structure and significance of cytogenetic abnormalities in adult patients with Ph-negative acute lymphoblastic leukemia

Inga Piskunova, Т. Н. Обухова, Е. Н. Паровичникова, С. М. Куликов, V. V. Troitskaya et al. (7 authors)

Terapevticheskii arkhiv2018-07-155 citations

10.26442/terarkh201890730-37

The Frequency and Impact of IKZF1 Deletions on Minimal Residual Disease in Adult Ph-Negative B-Cell Acute Lymphoblastic Leukemia Patients Treated in Russian Acute Lymphoblastic Leukemia Study

Galina Baskhaeva, Bella Biderman, Julia Davydova, Olga A. Gavrilina, Ksenija I. Zarubina et al. (12 authors)

Blood2017-12-07

10.1182/blood.v130.suppl_1.5002.5002

CDKN2A/p16INK4a DELETION IS NOT A POOR PROGNOSTIC FACTOR IN ADULT ACUTE LYMPHOBLASTIC LEUKEMIA PATIENTS TREATED ACCORDING TO PROTOCOL RALL-2009

Inga Piskunova, Т. Н. Обухова, Е. Н. Паровичникова, С. А. Куликов, Olga A. Gavrilina et al. (7 authors)

Oncohematology2017-10-253 citations

10.17650/1818-8346-2017-12-3-17-24

[Adult B-cell acute lymphoblastic leukemias: Conclusions of the Russian prospective multicenter study ALL-2009].

Parovichnikova EN, Troitskaya VV, Sokolov AN, Bondarenko SN, Gavrilina OA, Baskhaeva GA, Biderman BV, Lukyanova IA, Kuz'mina LA, Klyasova GA, Kravchenko SK, Gribanova EO, Zvonkov EE, Akhmerzaeva ZK, Baranova OY, Kaporskaya TS, Ryltsova TV, Zotina EN, Zinina EE, Samoilova OS, Kaplanov KD, Gavrilova LV, Konstantinova TS, Lapin VA, Pristupa AS, Eluferyeva AS, Obukhova TN, Piskunova IS, Gal'tseva IV, Dvirnyk VN, Rusinov MA, Kulikov SM, Savchenko VG.

2017-01-01

10.17116/terarkh201789710-17

The Different Treatment Approaches in Younger Patients with Angioimmunoblastic T-Cell Lymphoma

Н. Г. Чернова, Yulia E. Vinogradova, Е. Е. Звонков, Yulia Sidorova, А. М. Ковригина et al. (9 authors)

Blood2016-12-02

10.1182/blood.v128.22.5345.5345

No Differences in the Treatment Outcome in T-Cell Acute Lymphoblastic Leukemia/Lymphoma Regarding the Initial Bone Marrow Blasts Count: Results of the Russian Acute Lymphoblastic Leukemia (RALL) Study Group

Е. Н. Паровичникова, V. V. Troitskaya, А Н Соколов, Larisa A. Kuzmina, Sergey N. Bondarenko et al. (10 authors)

Blood2016-12-02

10.1182/blood.v128.22.5149.5149

De-Intensification of the Chemotherapy Did Not Affect the Outcome of Ph-Positive Acute Lymphocytic Leukemia Patients in the Era of Tyrosine Kinase Inhibitors

Olga A. Gavrilina, Е. Н. Паровичникова, V. V. Troitskaya, А Н Соколов, Larisa A. Kuzmina et al. (8 authors)

Blood2016-12-02

10.1182/blood.v128.22.2805.2805

Absence of High-Dose Consolidation Courses and Low Numbers of Allogeneic HSCTs Did Not Affect Overall Optimistic Results in B-Cell Precursor Ph-Negative Adult ALL Patients Treated By Non-Intensive but Non-Interruptive ALL-2009 Protocol: Data of the Russian ALL Study Group

Е. Н. Паровичникова, V. V. Troitskaya, А Н Соколов, G. A. Klyasova, Larisa A. Kuzmina et al. (30 authors)

Blood2015-12-031 citations

10.1182/blood.v126.23.2497.2497

Non-Intensive but Constant and Exhausting Action on the Leukemic Clone Is a Reasonable and Effective Treatment Approach in Adult Acute Lymphoblastic Leukemia: Results of the Russian Acute Lymphoblastic Leukemia (RALL) Study Group

Е. Н. Паровичникова, Vera Troitskaya, А Н Соколов, G. A. Klyasova, Larisa A. Kuzmina et al. (29 authors)

Blood2014-12-063 citations

10.1182/blood.v124.21.3662.3662

Interventions

PROCEDUREautologous HSCT

T-cell ALL patients recieve late consolidation with BEAM conditioning and stem cell support

Study design

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

15 Years to 55 Years

Healthy volunteers

No

Inclusion criteria

* Ph-negative precursors ALL * age 15-55 years * nontreated * Eastern Cooperative Oncology Group criterion status 0-3

Exclusion criteria

* B-mature ALL * Ph-positivity * pretreatment * Eastern Cooperative Oncology Group criterion status 4

Design outcomes

Primary

Measure	Time frame	Description
Proportion of adult ALL patients who tolerated the non-interrupted treatment	3 years	Number of patients who finished the protocol without any deviation, who were off the protocol due to toxicity, in whom the treatment schedule was modified and respectively the antileukemia efficacy in those subgroups

Secondary

Measure	Time frame	Description
Toxicity of prolonged L-asparaginase in adult patients	3 years	Number of patients who tolerated the scheduled L-asparaginase by dose and time sequence, proportion of patients shifted to PEG-asparaginase, in whom L-asparaginase was stopped and, respectively, the survival without leukemia of those patients

Countries

Russia

Outcome results

None listed

Multicenter Clinical Trial for Adult Ph-negative ALL. Non-intensive But Non-iterruptive Treatment

Conditions

Keywords

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Outcome results