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NCT06237192Recruiting

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

Source: ClinicalTrials.gov · Last updated 1 Feb 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
200 (estimated)
First submitted
3 Jan 2024
Start date
1 Apr 2023
Primary completion date
1 Sept 2026
Lead sponsor
National Research Center for Hematology, Russia
NCT number
NCT06237192

What you commit to

  • Study type: Interventional
  • Planned participants: 200
  • From 1 Apr 2023 to the primary completion date, 1 Sept 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Age

  • age more than 55 years old,

Other

  • Clinical diagnosis of Ph-positive ALL
  • Clinical diagnosis of relapsed/refractory ALL,

Who the study is looking for

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

Age in the registry: 18 years to 55 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Olga Aleshina
Coordinator of this site? Confirm its status
MoscowRussiaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.