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

Launched by GRUPO ARGENTINO DE TRATAMIENTO DE LA LEUCEMIA AGUDA · Nov 18, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at how well a specific treatment works for young adults and adolescents with a type of blood cancer called acute lymphoblastic leukemia (ALL) that is negative for a certain genetic marker (ph-negative). The study will take place in Argentina and aims to follow these patients over time to see how they respond to a treatment plan that is similar to what is used in children.

To participate in this trial, patients need to be between the ages of 16 and 30 and must have a confirmed diagnosis of ph-negative ALL without having received any previous treatment. Those with certain other types of leukemia or serious health conditions that could complicate treatment will not be eligible. Participants can expect to receive close monitoring and support throughout the study, helping researchers understand the effectiveness of this treatment approach for young patients.

Gender

ALL

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.