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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 remossion (CR) after the informed consent are randomized to: auto-HSCT vs no auto-HSCT, - with the similar further maintenance. Stem cell harvest is performed after the 3rd consolidation by G-SCF disregarding minimal residual disease (MRD) level. Auto-HSCT is planned after the 5th consolidation phase. All primary bone samples are collected and tested for cytogenetics and molecular markers, all included patients are monitored by flow cytometry by aberrant immunophenotype in a centralized lab.
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 patients are being randomized to auto-HSCT vs no auto-HSCT
Non-interruptive 5 consolidation phases with dose modification according to WBC and platelets count after CR achievement. Rotation of consolidation is permitted
After the 3rd consolidation stem cells harvesting is carried out for T-cell ALL patients randomized to auto-HSCT
Auto-HSCT after the 5th consolidation phase with non-myeloablative CEAM conditioning
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 auto-HSCT
Allo-HSCT is planned only for very high risk patients (11q23 ALL, MRD positivity at day +190)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| no Auto-HSCT | No Intervention | After completing prolonged consolidation T-cell ALL patients will continue with 2 years maintenance | |
| Auto-HSCT | Experimental | After completing prolonged consolidation T-cell ALL patients will get autologous HSCT followed by 2 years maintenance |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous HSCT | Procedure | After the 3rd consolidation, T-cell ALL patients, randomized to auto-HSCT will be mobilised by G-SCF and harvested disregarding MRD-status. After completing the 5th consolidation T-ALL patients will be transplanted after non-myeloablative CEAM (CCNU, Ethoposide, ARA-C, Melphalan) conditioning, and after reconstitution will continue 2-years maintenance |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival | Impact of autologous HSCT on DFS in T-cell ALL patients | 5-years |
| Measure | Description | Time Frame |
|---|---|---|
| MRD-negativity after consolidation | Minimal Residual Disease clearance on non-intensive but non-interruptive treatment | 6 months |
| Overall survival | Impact of de-escalated approach on OS |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elena N Parovichnikova, MD,PhD | Contact | +79161252623 | elenap@blood.ru | |
| Olga A Gavrilina, M.D. | Contact | dr.gavrilina@mail.ru |
| Name | Affiliation | Role |
|---|---|---|
| Valeriy V Savchenko, Academician | National Research Center for hematology, Moscow, Russia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Research Center for Hematology | Recruiting | Moscow | 125167 | Russia |
Each participating site has its on-line access to WEB-data base
Once a year
phone-call to coodinating center
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| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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|
| 5-years |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |