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

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

NCT ID: NCT06237192

Condition: Precursor Cell Lymphoblastic Leukemia-Lymphoma

Conditions: Official terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Venetoclax
Blinatumomab

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: blinatumomab for B-ALL, venetoclax for T-ALL
Description: MRD-associated based therapy for Ph-negative acute lymphoblastic leukemia
Arm group label: MRD-positive with Target therapy

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.

Detailed description: - 7 days prednisolone prephase - 8 weeks induction with de-escalation of induction chemotherapy: 3 instead of 4 dauno/vncr pulses, 1. instead of 2 Cph injections during induction, 2. 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)

Criteria for eligibility:
Criteria:
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,

Gender: All

Minimum age: 18 Years

Maximum age: 55 Years

Healthy volunteers: No

Locations:

Facility:
Name: Olga Aleshina

Address:
City: Moscow
Country: Russian Federation

Status: Recruiting

Contact:
Last name: Olga Aleshina

Phone: +79629745058

Start date: April 1, 2023

Completion date: September 1, 2027

Lead sponsor:
Agency: National Research Center for Hematology, Russia
Agency class: Other

Source: National Research Center for Hematology, Russia

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06237192