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

Not Applicable

Recruiting

• Conditions: Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Interventions: Drug: blinatumomab for B-ALL, venetoclax for T-ALL

• Registration Number: NCT06237192
• Lead Sponsor: National Research Center for Hematology, Russia

Brief 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)

Study Timeline

• Study Start: 2023-04-01
• Status Verified: 2024-01
• Study First Submitted: 2024-01-03
• Study First Submitted QC: 2024-01-31
• Last Update Submitted: 2024-01-31
• Study First Posted: 2024-02-01
• Last Update Posted: 2024-02-01
• Primary Completion: 2026-09-01
• Study Completion: 2027-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Disease-free survival	3-year	Rate of Diseases-free survival in MRD-positive ALL patients

Secondary Outcome Measures

Name	Time	Method
MRD-negativity after target therapy	1 month	Rate of Minimal Residual Disease negativity after target therapy
Overall survival	3-yaers OS	Rate of overall survival in protocol

Trial Locations

Locations (1)

Olga Aleshina; 🇷🇺 Moscow, Russian Federation