NCT03462095

De-escalated Treatment Approach for Adult Ph-negative Acute Lymphoblastic Leukemia (ALL)

Non-intensive But Non-interruptive Treatment of Adult Ph-negative Acute Lymphoblastic Leukemia With Randomization for Maintenance or Autologous Hematopoietic Stem Cell Transplantation (HSCT) Followed by Maintenance in T-cell ALL Patients

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 350 (estimated)
• Sponsor: National Research Center for Hematology, Russia · Network
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

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.

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 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)

Conditions

• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Type	Name	Description
PROCEDURE	Autologous HSCT	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

Timeline

• Start date: 2017-01-01
• Primary completion: 2019-12-01
• Completion: 2022-12-01
• First posted: 2018-03-12
• Last updated: 2018-03-13

Locations

1 site across 1 country: Russia