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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-40
SponsorGrupo Argentino de Tratamiento de la Leucemia Aguda

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

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 intervention

    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.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Adolescents and young adults Ph-negative ALL patients in first-line1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
36 months
2

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.

Time frame
36 months
3

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.

Time frame
36 months

Secondary outcomes

1

Evaluate survival in patients who underwent allogeneic transplantation in first remission

Time frame
36 months
2

Evaluate asparaginase toxicities.

Time frame
36 months
3

Assess central cerebrospinal fluid involvement by flow cytometry.

Time frame
36 months

Other outcomes

Sponsors and contacts

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