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

Inclusion Criteria2

Signature of the form consent for participation in the study
Ph-negative ALL diagnosis without previous treatment.

Exclusion Criteria12

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.
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.

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.