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

Recruiting now · Not applicable

Conditions studied: Precursor Cell Lymphoblastic Leukemia-Lymphoma

In brief

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.

Key facts

Study ID

NCT06237192

Run by

National Research Center for Hematology, Russia

People needed

200

Starts

2023-04-01

Expected to finish

2027-09-01

Last updated by the study team

2024-02-01

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• age 18-55 years old of patient,
• Clinical diagnosis of non-treated Ph-negative ALL

You may not qualify if…

• age more than 55 years old,
• Clinical diagnosis of Ph-positive ALL
• Clinical diagnosis of relapsed/refractory ALL,

Where it is running

• Olga Aleshina — Moscow, Russia (enrolling)

Full record on ClinicalTrials.gov

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