Evaluating pediatric-like treatment for young adults with Ph-negative acute lymphoblastic leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational clinical trial aims to gather real-world evidence on the treatment outcomes and toxicities of adolescent and young adult (AYA) patients with Ph-negative acute lymphoblastic leukemia (ALL) in Argentina. Participants will receive a first-line pediatric-like treatment protocol, and the study will assess survival rates, including event-free survival and overall survival, based on risk categories. Secondary endpoints include evaluating outcomes for patients who undergo allogeneic transplantation and assessing asparaginase toxicities. The trial will follow established guidelines for diagnosis and treatment throughout the participating institutions.

Why it matters

Who can join: the full rules

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.

Where it's running

• Instituto Privado de Hematologia y Hemoterapia
  Paraná, Entre Ríos Province, Argentina Recruiting
• Fundaleu
  Caba, Argentina Recruiting

Study contacts

• Principal investigator: Maria Moirano, Dr. — Grupo Argentino de Tratamiento de la Leucemia Aguda
• Study coordinator: Luciana Ferrari, Dr.
• Email: lferrari@fundaleu.org.ar
• Phone: 541148771000

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Pediatric-style chemotherapy with venetoclax and immunotherapy for adults with Ph-negative acute lymphoblastic leukemia

  This treatment plan tests whether pediatric-style chemotherapy combined with venetoclax and optional immunotherapy helps people aged 14–60 with newly diagnosed Ph-negative ALL achieve remission and clear minimal residual disease.

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• Combined chemotherapy with venetoclax and stem cell transplant for adults with Ph-negative ALL

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• Combining chemotherapy with CAR-T cell therapy for newly diagnosed adult patients with Philadelphia Chromosome Negative ALL

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  Recruiting Institute of Hematology & Blood Diseases Hospital, China · Tianjin · NCT06481241

• Combining CAR-T therapy with chemotherapy for newly diagnosed Ph+ acute lymphoblastic leukemia

  This study is testing a new treatment that combines CAR-T therapy with chemotherapy to see if it can help adults with newly diagnosed Ph+ acute lymphoblastic leukemia feel better and live longer.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.