MRD-associated Non-intensive But Non-interruptive Treatment of Ph-negative Acute Lymphoblastic Leukemia Adult Patients
Multicenter Prospective Study of Safety and Efficacy MRD-associated Non-intensive But Non-interruptive Treatment of Ph-negative Acute Lymphoblastic Leukemia Adult Patients
National Research Center for Hematology, Russia
200 participants
Apr 1, 2023
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria2
- • age 18-55 years old of patient,
- \- Clinical diagnosis of non-treated Ph-negative ALL
Exclusion Criteria3
- • age more than 55 years old,
- Clinical diagnosis of Ph-positive ALL
- Clinical diagnosis of relapsed/refractory ALL,
Interventions
MRD-associated based therapy for Ph-negative acute lymphoblastic leukemia
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06237192