NCT05127148 RWE of Pediatric-like Protocol for AYA Patients With Ph-negative ALL
| NCT ID | NCT05127148 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Grupo Argentino de Tratamiento de la Leucemia Aguda |
| Condition | Acute Lymphoblastic Leukemia, Adult |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2021-03-01 |
| Primary Completion | 2026-03-01 |
Trial Parameters
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Brief 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.
Eligibility Criteria
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. * Patien
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