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

National Research Center for Hematology, Russia

Status: Enrolling

Conditions: Precursor Cell Lymphoblastic Leukemia-Lymphoma

Treatments: Drug: blinatumomab for B-ALL, venetoclax for T-ALL

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT06237192

RALL-2016m

Details and patient eligibility

About

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.

Full description

• 7 days prednisolone prephase

• 8 weeks induction with de-escalation of induction chemotherapy: 3 instead of 4 dauno/vncr pulses,

  1. instead of 2 Cph injections during induction,
  2. instead of 4 ARA-C blocks, distribution of of L-asp injections through all phases

• After CR achievement T-cell ALL and B-ALL patients are being study MRD (by FCM) MRD-positive patients with T-ALL will receive 1-3 consolidation with venetoclax (400 mg/d), and B-ALL patients will receive1 additional consolidation by blinatumomab

• Non-interruptive 5 consolidation phases with dose modification according to WBC and platelets count after CR achievement. Rotation of consolidation is permitted

• 2 years maintenance for all patients

• 21 TIT through the whole treatment with higher intensity during induction|consolidation

• Centralized MRD monitoring at +70 d, + 133 d, + 190 days; before and after allo-HSCT

• Allo-HSCT is planned only for very high risk patients (11q23 ALL, MRD positivity after target therapy, ETP T-ALL)

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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,

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

MRD-positive with Target therapy

Experimental group

Description:

MRD-positive patients after induction therapy in target therapy group (for B-ALL- blinatumomab, for T-ALL - venetoclax+ChT)

Treatment:

Drug: blinatumomab for B-ALL, venetoclax for T-ALL