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

NCT ID: NCT06237192

Last Updated: 2024-02-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2027-09-01

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)

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MRD-positive with Target therapy

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

Group Type: EXPERIMENTAL

blinatumomab for B-ALL, venetoclax for T-ALL

Intervention Type: DRUG

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

Interventions

blinatumomab for B-ALL, venetoclax for T-ALL

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

Intervention Type: DRUG

Eligibility Criteria

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,

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Research Center for Hematology, Russia

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elena Parovichnikova, MD, PhD

Role: STUDY_DIRECTOR

National Research Medical Center for Hematology

Locations

Olga Aleshina

Moscow, , Russia

Site Status: RECRUITING

Countries

Russia

Central Contacts

Olga Aleshina, MD, PhD

Role: CONTACT

dr.gavrilina@mail.ru

+79629745058

Facility Contacts

Olga Aleshina

Role: primary

+79629745058

Other Identifiers

RALL-2016m

Identifier Type: -

Identifier Source: org_study_id