Clinical trial · Interventional
Treatment of High Risk Adult Acute Lymphoblastic Leukemia
- 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)
Current therapeutic protocols for adult ALL consider MRD together with the baseline risk factors (age, WBC count, immunophenotype, cytogenetics) and speed in response to therapy for treatment decisions. On the other hand, the systematic use of allogeneic SCT for all adult patients (pts) with Ph- HR-ALL is still a matter of debate. The aim of the prospective study ALL-AR-03 from the Spanish PETHEMA Group was to evaluate the response to a differentiated therapy (chemotherapy or allogeneic SCT) according to early bone marrow blast clearance and MRD levels (assessed by cytofluorometry at the end of induction and consolidation therapy) in HR Ph- adult ALL patients.
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 |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (12)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ASP | Drug | — | UNRESOLVED |
| Cytarabine | Drug | Cytarabine | ALIAS |
| Cytosine Arabinoside | Drug | Cytarabine | ALIAS |
| Daunorubicin | Drug | Daunorubicin | ALIAS |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Hydrocortisone | Drug | — | UNRESOLVED |
| Mercaptopurine | Drug | Mercaptopurine | ALIAS |
| Methotrexate (MTX) | Drug | Methotrexate | ALIAS |
| Mitoxantrone |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To evaluate the response to a differentiated therapy (chemotherapy or allogeneic SCT) according to early bone marrow blast clearance and MRD levels in HR Ph- adult ALL patients.
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
Inclusion Criteria: * High risk ALL adult patients (age\> 15 years)no treated previously * High-risk ALL: * One or more of the following: * Age 30-60 yr. * WBC count \>25x109/L * 11q23 or ALL1/AF4 * Very high-risk ALL: * HR ALL and one or the following: * Slow cytologic response (\>10% blasts in BM on d14 of induction therapy). * MRD\>0.05% (by flow cytometry) at the end of consolidation Exclusion Criteria: * L3 ALL or B mature(sIg +) or t(8;14), t(2;8), t(8;22). * ALL Ph (BCR/ABL) positive. * Bifenotipics ALL as EGIL criteria. * Indifferentiated ALL. * Patients with cardiac pathology * Patients with chronic liver disease in activity fase * Pulmonary disease * Renal insufficiency not due to ALL * Neurological disorders not due to ALL * PS (grades 3 and 4) not due to ALL.
References
Publications (1)
- DERIVEDRibera JM, Oriol A, Morgades M, Montesinos P, Sarra J, Gonzalez-Campos J, Brunet S, Tormo M, Fernandez-Abellan P, Guardia R, Bernal MT, Esteve J, Barba P, Moreno MJ, Bermudez A, Cladera A, Escoda L, Garcia-Boyero R, Del Potro E, Bergua J, Amigo ML, Grande C, Rabunal MJ, Hernandez-Rivas JM, Feliu E. Treatment of high-risk Philadelphia chromosome-negative acute lymphoblastic leukemia in adolescents and adults according to early cytologic response and minimal residual disease after consolidation assessed by flow cytometry: final results of the PETHEMA ALL-AR-03 trial. J Clin Oncol. 2014 May 20;32(15):1595-604. doi: 10.1200/JCO.2013.52.2425. Epub 2014 Apr 21. PMID 24752047