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RWE of Pediatric-like Protocol for AYA Patients With Ph-negative ALL

RECRUITINGSponsored by Grupo Argentino de Tratamiento de la Leucemia Aguda
Actively Recruiting
SponsorGrupo Argentino de Tratamiento de la Leucemia Aguda
Started2021-03-01
Est. completion2026-03-01
Eligibility
Age18 Years – 40 Years

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

Age: 18 Years – 40 Years
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.
* 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.

Conditions2

Acute Lymphoblastic Leukemia, AdultCancer

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