NCT05127148 RWE of Pediatric-like Protocol for AYA Patients With Ph-negative ALL
| NCT ID | NCT05127148 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Grupo Argentino de Tratamiento de la Leucemia Aguda |
| Condition | Acute Lymphoblastic Leukemia, Adult |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2021-03-01 |
| Primary Completion | 2026-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2021-03-01 with a primary completion date of 2026-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Maria Moirano, Dr.
PRINCIPAL INVESTIGATOR
Grupo Argentino de Tratamiento de la Leucemia Aguda
Frequently Asked Questions
Who can join the NCT05127148 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 40 Years, studying Acute Lymphoblastic Leukemia, Adult. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05127148 currently recruiting?
Yes, NCT05127148 is actively recruiting participants. Contact the research team at lferrari@fundaleu.org.ar for enrollment information.
Where is the NCT05127148 trial being conducted?
This trial is being conducted at Paraná, Argentina, CABA, Argentina.
Who is sponsoring the NCT05127148 clinical trial?
NCT05127148 is sponsored by Grupo Argentino de Tratamiento de la Leucemia Aguda. The principal investigator is Maria Moirano, Dr. at Grupo Argentino de Tratamiento de la Leucemia Aguda. The trial plans to enroll 100 participants.
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