RecruitingNot ApplicableNCT06237192

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


Sponsor

National Research Center for Hematology, Russia

Enrollment

200 participants

Start Date

Apr 1, 2023

Study Type

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

Min Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a less intensive but continuous treatment approach for adults with a type of blood cancer called Ph-negative acute lymphoblastic leukemia (ALL). Researchers are tracking a measure called minimal residual disease (MRD) — tiny amounts of cancer cells remaining after treatment — to guide therapy decisions and avoid over-treatment. **You may be eligible if...** - You are between 18 and 55 years old - You have been newly diagnosed with Ph-negative ALL (a specific type of leukemia that does not have the Philadelphia chromosome) - You have not yet received treatment for this condition **You may NOT be eligible if...** - You are older than 55 - Your leukemia is Ph-positive (has the Philadelphia chromosome) - Your leukemia has already been treated or has come back after previous treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGblinatumomab for B-ALL, venetoclax for T-ALL

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


Locations(1)

Olga Aleshina

Moscow, Russia

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NCT06237192


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