Precursor Cell Lymphoblastic Leukemia-Lymphoma
Conditions
Brief 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)
Interventions
DRUGblinatumomab for B-ALL, venetoclax for T-ALL
MRD-associated based therapy for Ph-negative acute lymphoblastic leukemia
Sponsors
National Research Center for Hematology, Russia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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,
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease-free survival | 3-year | Rate of Diseases-free survival in MRD-positive ALL patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MRD-negativity after target therapy | 1 month | Rate of Minimal Residual Disease negativity after target therapy |
| Overall survival | 3-yaers OS | Rate of overall survival in protocol |
Countries
Russia
Contacts
Primary ContactOlga Aleshina, MD, PhD
Outcome results
None listed