Clinical trial · Observational
RWE of Pediatric-like Protocol for AYA Patients With Ph-negative ALL
Real-world Evidence of First-line Treatment With Pediatric-like Protocol for Adolescents and Young Adults Patients Diagnosed With Philadelphia-negative Acute Lymphoblastic Leukemia
NCT05127148CI-TRIAL-00072841recruitingClinicalTrials.gov clinicaltrialsProvenance
- 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)
This is a multicenter, observational real world clinical trial with prospective follow up that will evaluate the treatment outcome of adolescent and young patients with ph-negative acute lymphoblastic leukemia with first-line pediatric-like protocol in Argentina.
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, Adult | Adult Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Evaluation of survival and toxicities in AYA Ph-negative ALL patients treating in first line depending on risk category. | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Adolescents and young adults Ph-negative ALL patients in first-line
- description
- Adolescents and young adults patients (18-40 years old) with recent diagnosis of Ph-negative acute lymphoblastic leukemia who receive argentinian pediatric-like treatment depending on risk category.
- interventionNames
- Other: Evaluation of survival and toxicities in AYA Ph-negative ALL patients treating in first line depending on risk category.
Primary outcomes (3)
- measure
- Evaluate event free survival of AYA Ph-negative ALL patients treating in first line depending on risk category.
- timeFrame
- 36 months
- description
- Evaluate event free survival of AYA Ph-negative ALL patients treating in first line with pediatric-like protocol depending on risk category.
- measure
- Evaluate overall survival of AYA Ph-negative ALL patients treating in first line depending on risk category.
- timeFrame
- 36 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * Signature of the form consent for participation in the study * Ph-negative ALL diagnosis without previous treatment. Exclusion Criteria: * ALL with mature B phenotype (sIg +) or with the cytogenetic alterations characteristic of ALL mature B (t (8,14), t (2, 8), t (8, 22)). * Ph-positive ALL * Acute leukemias of ambiguous lineage (undifferentiated or mixed phenotype). * Patients with a history of coronary, valvular or hypertensive heart disease, that contraindicate the use of anthracyclines. * Patients with chronic liver disease in the activity phase and / or Bilirubin\> 2 mg / dl and / or transaminases 5 times the normal limit, not related to ALL. * Patients with severe chronic respiratory failure. * Renal failure and / or creatininemia\> 2 mg / dl not related to ALL. * Serious neurological disorders, not related to leukemic disease. * General condition affected (grades 3 and 4), not attributable to ALL. * Uncontrolled infection by HIV, HTLV-1, HBV, HCV. * Patient not a candidate for treatment based on the criteria of the treating physician. * Pregnant women will have to be evaluated by a multidisciplinary team and an ethics committee.
References
Publications (0)
Data not yet available
No reference posted for this study.