NCT06237192

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: National Research Center for Hematology, Russia · Network
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Detailed 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)

Conditions

• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Type	Name	Description
DRUG	blinatumomab for B-ALL, venetoclax for T-ALL	MRD-associated based therapy for Ph-negative acute lymphoblastic leukemia

Timeline

• Start date: 2023-04-01
• Primary completion: 2026-09-01
• Completion: 2027-09-01
• First posted: 2024-02-01
• Last updated: 2024-02-01

Locations

1 site across 1 country: Russia