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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: f
View:

• • age 18-55 years old of patient,

• \- Clinical diagnosis of non-treated Ph-negative ALL

Locations
Other Locations
Russian Federation
Olga Aleshina
RECRUITING
Moscow
Contact Information
Primary
Olga Aleshina, MD, PhD
dr.gavrilina@mail.ru
+79629745058
Time Frame
Start Date: 2023-04-01
Estimated Completion Date: 2027-09-01
Participants
Target number of participants: 200
Treatments
Experimental: MRD-positive with Target therapy
MRD-positive patients after induction therapy in target therapy group (for B-ALL- blinatumomab, for T-ALL - venetoclax+ChT)
Sponsors
Leads: National Research Center for Hematology, Russia

This content was sourced from clinicaltrials.gov