About this trial
Non-intensive But Non-interruptive Treatment based on previously study RALL-2016 of Adult Ph-negative Acute Lymphoblastic Leukemia: 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 remission (CR) with MRD-positive status after 2nd induction receive consolidation 1-3 with venetoclax (56 days), and B-ALL patients in complete remission (CR) with MRD-positive status after 2nd induction receive 1 consolidation with blinatumomab. After that consolidation bone samples are collected and tested for MRD and patients will continue therapy by protocol without HSCT if MRD-negative (by flow cytometry by aberrant immunophenotype in a centralized lab) status was achieved.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Clinical diagnosis of Ph-positive ALL
Clinical diagnosis of relapsed/refractory ALL,
Trial design
Single group
Treatments tested in this trial
blinatumomab for B-ALL, venetoclax for T-ALL
DrugMRD-associated based therapy for Ph-negative acute lymphoblastic leukemia
Treatment groups
Trial outcomes
Primary outcomes
Disease-free survival
Rate of Diseases-free survival in MRD-positive ALL patients
Secondary outcomes
MRD-negativity after target therapy
Rate of Minimal Residual Disease negativity after target therapy
Overall survival
Rate of overall survival in protocol
Sponsors and contacts
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