Tracks outcomes of a pediatric-style treatment for young adults with acute leukemia
Observes how young adults with Philadelphia-negative acute lymphoblastic leukemia fare on first-line pediatric-style treatment.
Plain-language title generated from the registry record
Registry title: RWE of Pediatric-like Protocol for AYA Patients With Ph-negative ALL
Key facts
- Where
- CABA and Paraná, ArgentinaSee the 2 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 40 years old?
Source: NCT05127148, who can take part
Where in Argentina
- FUNDALEUCABA, ArgentinaTaking people
- Instituto Privado de Hematologia y HemoterapiaParaná, ArgentinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Grupo Argentino de Tratamiento de la Leucemia Aguda
- Trial code
- NCT05127148
- Record updated
- 9 January 2024
- Original description
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.Read full original descriptionShow less
Real-world Evidence of First-line Treatment With Pediatric-like Protocol for Adolescents and Young Adults Patients Diagnosed With Philadelphia-negative Acute Lymphoblastic Leukemia
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.
Inclusion: Signature of the form consent for participation in the study; Ph-negative ALL diagnosis without previous treatment.
Exclusion: Patients with a history of coronary, valvular or hypertensive heart disease, that contraindicate the use of anthracyclines; 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; 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; 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); 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.