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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.
7 days prednisolone prephase
8 weeks induction with de-escalation of induction chemotherapy: 3 instead of 4 dauno/vncr pulses,
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MRD-positive with Target therapy | Experimental | MRD-positive patients after induction therapy in target therapy group (for B-ALL- blinatumomab, for T-ALL - venetoclax+ChT) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| blinatumomab for B-ALL, venetoclax for T-ALL | Drug | MRD-associated based therapy for Ph-negative acute lymphoblastic leukemia |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival | Rate of Diseases-free survival in MRD-positive ALL patients | 3-year |
| Measure | Description | Time Frame |
|---|---|---|
| MRD-negativity after target therapy | Rate of Minimal Residual Disease negativity after target therapy | 1 month |
| Overall survival | Rate of overall survival in protocol |
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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,
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Olga Aleshina, MD, PhD | Contact | +79629745058 | dr.gavrilina@mail.ru |
| Name | Affiliation | Role |
|---|---|---|
| Elena Parovichnikova, MD, PhD | National Research Medical Center for Hematology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Olga Aleshina | Recruiting | Moscow | Russia |
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| 3-yaers OS |
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C510808 | blinatumomab |
| C579720 | venetoclax |
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