Clinical trial NCT01193933: Multicenter Clinical Trial for Adult Ph-negative ALL. Non-intensive But Non-iterruptive Treatment
Official title: Multicenter Clinical Trial for Adult Ph-negative ALL. Evaluation of the Impact of the Prolonged L-asparaginase Therapy During Continuous Treatment With Modification of Cytostatic Drugs Doses Depending on Myelosuppression Severity.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ph-negative Adult Acute Lymphoblastic Leukemia
Keywords: adult ALL
Ph-negative
dexamethasone
L-asparaginase
Lead sponsor: National Research Center for Hematology, Russia
Sponsor class: NETWORK
First posted: 2010-09-02
Enrollment: 321
Sex: ALL
Minimum age (years): 15
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of adult ALL patients who tolerated the non-interrupted treatment
timeFrame: 3 years
Secondary outcomes:
measure: Toxicity of prolonged L-asparaginase in adult patients
timeFrame: 3 years
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Russian Acute Lymphoblastic Leukemia Study group
Study officials:
affiliation: National Research Center for Hematology
name: Valeri G Savchenko, Professor
role: STUDY_CHAIR
References:
citation: Parovichnikova EN, Troitskaya VV, Gavrilina OA, Sokolov AN, Kokhno AV, Klyasova GA, Kuzmina LA, Galstyan GM, Makhinya SA, Latyshkevich OA, Kaporskaya TS, Lapin VA, Chabaeva YA, Kulikov SM, Savchenko VG; for Russian Acute Lymphoblastic Leukemia group. The outcome of Ph-negative acute lymphoblastic leukemia presenting during pregnancy and treated on the Russian prospective multicenter trial RALL-2009. Leuk Res. 2021 May;104:106536. doi: 10.1016/j.leukres.2021.106536. Epub 2021 Feb 14.
citation: Parovichnikova E, Troitskaya V, Sokolov A, Gavrilina O, Akhmerzaeva Z, Kuzmina L, Kliasova G, Chabaeva J, Kulikov S, Bondarenko S, Baranova O, Samoilova O, Kaplanov K, Minaeva N, Savchenko V; Russian Acute Lymphoblastic Leukemia Group. Can Less Intensive Chemotherapy and an Autotransplant Cure Adult T-Cell Acute Lymphoblastic Leukemia? Acta Haematol. 2020;143(2):131-139. doi: 10.1159/000502435. Epub 2019 Oct 9.
citation: Piskunova IS, Obukhova TN, Parovichnikova EN, Kulikov SM, Troitskaya VV, Gavrilina OA, Savchenko VG. Structure and significance of cytogenetic abnormalities in adult patients with Ph-negative acute lymphoblastic leukemia. Ter Arkh. 2018 Aug 17;90(7):30-37. doi: 10.26442/terarkh201890730-37.
citation: 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. [Adult B-cell acute lymphoblastic leukemias: Conclusions of the Russian prospective multicenter study ALL-2009]. Ter Arkh. 2017;89(7):10-17. doi: 10.17116/terarkh201789710-17. Russian.
citation: Parovichnikova EN, Kuzmina LA, Mendeleeva LP, Klyasova GA, Troitskaya VV, Sokolov AN, Akhmerzaeva ZK, Kravchenko SK, Gribanova EO, Zvonkov EE, Bondarenko SN, Baranova OY, Ryltsova TV, Gavrilova LV, Zinina EE, Pristupa AS, Kaporskaya TS, Minaeva NV, Samoilova OS, Konstantinova TS, Lapin VA, Kaplanov KD, Kryuchkova IV, Nizamutdinova AS, Klimovich AV, Borisenkova EA, Moskov VI, Gaponova TV, Obukhova TV, Galtseva IV, Rusinov MA, Kulikov SM, Savchenko VG. [Autologous hematopoietic stem cell transplantation as late high-dose consolidation in adult patients with T-cell lymphoblastic leukemias: Results of a Russian multicenter study]. Ter Arkh. 2015;87(7):15-25. doi: 10.17116/terarkh201587715-25. Russian.