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

NCT06237192 | Recruiting

• 1 other identifier: RALL-2016m
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Outcome Measures

Primary Outcomes (1)

• Disease-free survival

  Rate of Diseases-free survival in MRD-positive ALL patients

  3-year

Secondary Outcomes (2)

• MRD-negativity after target therapy

  1 month

• Overall survival

  3-yaers OS

Study Arms (1)

MRD-positive with Target therapy

EXPERIMENTAL

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

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

Interventions

blinatumomab for B-ALL, venetoclax for T-ALL DRUG

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

MRD-positive with Target therapy

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• age 18-55 years old of patient,
• \- Clinical diagnosis of non-treated Ph-negative ALL

You may not qualify if:

• age more than 55 years old,
• Clinical diagnosis of Ph-positive ALL
• Clinical diagnosis of relapsed/refractory ALL,

Sponsors & Collaborators

• National Research Center for Hematology, Russia: lead

Study Sites (1)

Olga Aleshina

Moscow, Russia

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

blinatumomab; venetoclax

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Elena Parovichnikova, MD, PhD

  National Research Medical Center for Hematology

  STUDY DIRECTOR

Central Study Contacts

Olga Aleshina, MD, PhD

CONTACT

+79629745058; dr.gavrilina@mail.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2024
• First Posted: February 1, 2024
• Study Start: April 1, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: February 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)