Actively Recruiting

Age: 18Years - 40Years
All Genders
NCT05127148

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

Led by Grupo Argentino de Tratamiento de la Leucemia Aguda · Updated on 2024-01-09

100

Participants Needed

2

Research Sites

300 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 40Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed consent form for participation in the study
  • Diagnosis of Philadelphia chromosome-negative acute lymphoblastic leukemia (Ph-negative ALL) without previous treatment
Not Eligible

You will not qualify if you...

  • Acute lymphoblastic leukemia with mature B phenotype or characteristic cytogenetic alterations
  • Philadelphia chromosome-positive acute lymphoblastic leukemia
  • Acute leukemias of ambiguous lineage (undifferentiated or mixed phenotype)
  • History of coronary, valvular, or hypertensive heart disease contraindicating anthracycline use
  • Chronic liver disease with active symptoms or significant liver function abnormalities unrelated to ALL
  • Severe chronic respiratory failure
  • Renal failure or elevated creatinine not related to ALL
  • Serious neurological disorders not related to leukemia
  • Poor general condition (grades 3 and 4) not due to ALL
  • Uncontrolled infections with HIV, HTLV-1, HBV, or HCV
  • Not considered a candidate for treatment by the treating physician
  • Pregnancy requiring multidisciplinary and ethics committee evaluation

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

Instituto Privado de Hematologia y Hemoterapia

Paraná, Entre Ríos Province, Argentina

Actively Recruiting

2

FUNDALEU

CABA, Argentina

Actively Recruiting

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Research Team

L

Luciana Ferrari, Dr.

CONTACT

P

Paula Freigeiro

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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