RecruitingNCT05127148

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

Sponsor

Grupo Argentino de Tratamiento de la Leucemia Aguda

Enrollment

100 participants

Start Date

Mar 1, 2021

Study Type

OBSERVATIONAL

Conditions

Acute Lymphoblastic Leukemia, Adult

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

Min Age: 18 YearsMax Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This is a real-world evidence (RWE) study examining how well a "pediatric-like" chemotherapy protocol — originally designed for children and young adults — works in adolescent and young adult (AYA) patients (typically ages 15–39) with Philadelphia chromosome-negative acute lymphoblastic leukemia (ALL), a type of blood cancer. This study looks at outcomes in real clinical practice rather than in a controlled trial setting. **You may be eligible if...** - You have been diagnosed with Philadelphia chromosome-negative (Ph-negative) ALL and have not yet received any treatment - You have signed the consent form to participate **You may NOT be eligible if...** - Your leukemia is mature B-cell ALL or Burkitt-type (with specific chromosomal changes: t(8;14), t(2;8), or t(8;22)) - You have Philadelphia chromosome-positive ALL (BCR-ABL positive) - You have ambiguous lineage leukemia (mixed phenotype) - You have significant heart, liver, kidney, or lung disease that is not caused by the leukemia itself - You have uncontrolled HIV, HTLV-1, Hepatitis B, or Hepatitis C infection - You are pregnant (evaluated on a case-by-case basis) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHEREvaluation of survival and toxicities in AYA Ph-negative ALL patients treating in first line depending on risk category.

Evaluation 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.