Evaluating pediatric-like treatment for young adults with Ph-negative acute lymphoblastic leukemia
Real-world Evidence of First-line Treatment With Pediatric-like Protocol for Adolescents and Young Adults Patients Diagnosed With Philadelphia-negative Acute Lymphoblastic Leukemia
This study is testing a pediatric-style treatment for young adults with Ph-negative acute lymphoblastic leukemia in Argentina to see how well it works and what side effects it may have.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | Grupo Argentino de Tratamiento de la Leucemia Aguda Academic / other |
| Drugs / interventions | chemotherapy, methotrexate, cyclophosphamide, prednisone |
| Locations | 2 sites (Paraná, Entre Ríos Province and 1 other locations) |
| Trial ID | NCT05127148 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adolescents and young adults diagnosed with Ph-negative acute lymphoblastic leukemia who have not received prior treatment.
Not a fit: Patients with Ph-positive ALL or those with mature B phenotype acute leukemias will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment outcomes for young adults with Ph-negative ALL by validating a pediatric-like treatment approach.
How similar studies have performed: Other studies have shown promising results using pediatric-like protocols for treating ALL, suggesting potential success for this approach in AYA patients.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Paraná, Entre Ríos Province and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.