RWE of Pediatric-like Protocol for AYA Patients With Ph-negative ALL
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.
| Condition(s) | Acute Lymphoblastic Leukemia, Adult |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | 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. |
| Who can participate | 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 |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Lead sponsor | Grupo Argentino de Tratamiento de la Leucemia Aguda |
| Locations | Paraná, Entre Ríos Province, Argentina; CABA, Argentina |
| Start date | 2021-03-01 |
| NCT ID | NCT05127148 |
| Official listing | https://clinicaltrials.gov/study/NCT05127148 |