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

Precursor Cell Lymphoblastic Leukemia-Lymphoma Clinical Trial

Official title: Multicenter Prospective Study of Safety and Efficacy MRD-associated Non-intensive But Non-interruptive Treatment of Ph-negative Acute Lymphoblastic Leukemia Adult Patients

Status Recruiting

Clinical Trial 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.

Clinical Trial 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) ;

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

• NCT number: NCT06237192
• Study type: Interventional
• Source: National Research Center for Hematology, Russia
• Contact: Olga Aleshina, MD, PhD
• Phone: +79629745058
• Email: dr.gavrilina@mail.ru
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2023
• Completion date: September 1, 2027