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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorNational Research Center for Hematology, Russia

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Clinical diagnosis of Ph-positive ALL

Clinical diagnosis of relapsed/refractory ALL,

Trial design

Design model

Single group

Treatments tested in this trial

  • blinatumomab for B-ALL, venetoclax for T-ALL

    Drug

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

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: MRD-positive with Target therapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Disease-free survival

Rate of Diseases-free survival in MRD-positive ALL patients

Time frame
3-year

Secondary outcomes

1

MRD-negativity after target therapy

Rate of Minimal Residual Disease negativity after target therapy

Time frame
1 month
2

Overall survival

Rate of overall survival in protocol

Time frame
3-yaers OS

Other outcomes

Sponsors and contacts

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