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NCT06237192

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

Recruiting now NA Last updated 1 February 2024
What this trial tests

NA trial testing blinatumomab for B-ALL, venetoclax for T-ALL in Precursor Cell Lymphoblastic Leukemia-Lymphoma in 200 participants. Currently enrolling.

Timeline
1 April 2023
Primary endpoint
1 September 2026
1 September 2027

Quick facts

Lead sponsorNational Research Center for Hematology, Russia
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment200
Start date1 April 2023
Primary completion1 September 2026
Estimated completion1 September 2027
Sites1 location across Russia

Drugs / interventions tested

Conditions studied

Sponsor

National Research Center for Hematology, Russia — full company profile →

Who can join

Adults 18 to 55, any sex, with Precursor Cell Lymphoblastic Leukemia-Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Upfront Immunotherapy Approaches in the Management of Adults with Acute Lymphoblastic Leukemia.
    Shahzad M, Amin MK, Badar T. · · 2025 · PMID 40940843 · DOI 10.3390/cancers17172746
  2. EHA2024 Hybrid Congress
    · 2024

Verify or expand the search:

Other recruiting trials for Precursor Cell Lymphoblastic Leukemia-Lymphoma

Currently open trials in the same condition.

Other National Research Center for Hematology, Russia trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06237192.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing