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MRD-associated Non-intensive But Non-interruptive Treatment of Ph-negative Acute Lymphoblastic Leukemia Adult Patients

RECRUITINGN/ASponsored by National Research Center for Hematology, Russia
Actively Recruiting
PhaseN/A
SponsorNational Research Center for Hematology, Russia
Started2023-04-01
Est. completion2026-09-01
Eligibility
Age18 Years – 55 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06237192

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

Age: 18 Years – 55 YearsHealthy volunteers accepted
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,

Conditions2

CancerPrecursor Cell Lymphoblastic Leukemia-Lymphoma

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