About this trial
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
This trial does not accept healthy volunteersQualifiers
Signature of the form consent for participation in the study
Ph-negative ALL diagnosis without previous treatment.
Disqualifiers
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.
Trial population
All AYA (18-40 years old) with recent diagnosis of ph-negative ALL without previous treatment.
Trial design
Cohort
Prospective
Treatments tested in this trial
Evaluation of survival and toxicities in AYA Ph-negative ALL patients treating in first line depending on risk category.
Other interventionEvaluation of survival (event free survival and overall survival) and toxicities in AYA Ph-negative ALL patients treating in first line with argentinian pediatric-like protocol depending on risk category.
Treatment groups
Trial outcomes
Primary outcomes
Evaluate event free survival of AYA Ph-negative ALL patients treating in first line depending on risk category.
Evaluate event free survival of AYA Ph-negative ALL patients treating in first line with pediatric-like protocol depending on risk category.
Evaluate overall survival of AYA Ph-negative ALL patients treating in first line depending on risk category.
Evaluate overall survival of AYA Ph-negative ALL patients treating in first line with pediatric-like protocol depending on risk category.
Evaluate toxicities of AYA Ph-negative ALL patients treating in first line depending on risk category.
Evaluate toxicities of AYA Ph-negative ALL patients treating in first line with pediatric-like protocol depending on risk category.
Secondary outcomes
Evaluate survival in patients who underwent allogeneic transplantation in first remission
Evaluate asparaginase toxicities.
Assess central cerebrospinal fluid involvement by flow cytometry.
Sponsors and contacts
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