RECRUITINGINTERVENTIONAL

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

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.

Who May Be Eligible (Plain English)

Who May Qualify: • age 18-55 years old of patient, \- Clinical diagnosis of non-treated Ph-negative ALL Who Should NOT Join This Trial: • age more than 55 years old, - Clinical diagnosis of Ph-positive ALL - Clinical diagnosis of relapsed/refractory ALL, Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: • age 18-55 years old of patient, \- Clinical diagnosis of non-treated Ph-negative ALL Exclusion Criteria: • age more than 55 years old, * Clinical diagnosis of Ph-positive ALL * Clinical diagnosis of relapsed/refractory ALL,

Treatments Being Tested

DRUG

blinatumomab for B-ALL, venetoclax for T-ALL

MRD-associated based therapy for Ph-negative acute lymphoblastic leukemia

Locations (1)

Olga Aleshina

Moscow, Russia