Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Precursor Cell Lymphoblastic Leukemia-Lymphoma | Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Autologous HSCT | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- no Auto-HSCT
- description
- After completing prolonged consolidation T-cell ALL patients will continue with 2 years maintenance
- type
- EXPERIMENTAL
- label
- Auto-HSCT
- description
- After completing prolonged consolidation T-cell ALL patients will get autologous HSCT followed by 2 years maintenance
- interventionNames
- Procedure: Autologous HSCT
Primary outcomes (1)
- measure
- Disease-free survival
- timeFrame
- 5-years
- description
- Impact of autologous HSCT on DFS in T-cell ALL patients
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: * age 18-55 yy, newly diagnosed non-treated Ph-negative ALL Exclusion Criteria: * age \> 55 yy, Ph-positivity, relapsed\|refractory ALL, pretreated ALL
References
Publications (0)
Data not yet available