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NCT Number: NCT06237192

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

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.

Recruiting

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Olga Aleshina

Moscow, Russia

Location status: Recruiting

Location contact

Olga Aleshina

CONTACT

+79629745058

About this study

  • 7 days prednisolone prephase
  • 8 weeks induction with de-escalation of induction chemotherapy: 3 instead of 4 dauno/vncr pulses,
  • instead of 2 Cph injections during induction,
  • 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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

blinatumomab for B-ALL, venetoclax for T-ALL

Drug

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

Primary outcomes

  1. Disease-free survival

    Time frame: 3-year

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

Secondary outcomes

  1. MRD-negativity after target therapy

    Time frame: 1 month

    Rate of Minimal Residual Disease negativity after target therapy

  2. Overall survival

    Time frame: 3-yaers OS

    Rate of overall survival in protocol

Study contacts

Contact information is provided by the study sponsor or research team.

Olga Aleshina, MD, PhD

CONTACT

[email protected]

+79629745058

Sponsors and collaborators

Lead sponsor

National Research Center for Hematology, Russia

Network

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Feb 1, 2024
Registry last updated
Feb 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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