Adult Acute Lymphoblastic Leukemia Treated With Pediatric Regimen in Brazil

Launched by INSTITUTO DO CANCER DO ESTADO DE SÃO PAULO · Jul 17, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for adults aged 16 to 50 who have recently been diagnosed with a type of blood cancer called Acute Lymphoblastic Leukemia (ALL) that does not involve a specific gene abnormality known as the Philadelphia chromosome. The trial is using a treatment plan that has been effective in children, which includes a special drug called peg-asparaginase. The main goal is to see if this pediatric treatment can help patients live longer and have fewer health problems after treatment.

To be eligible for this study, patients must be newly diagnosed with ALL and have a certain amount of cancer cells in their blood or bone marrow. Some people, like those with other specific types of leukemia, certain serious health conditions, or previous chemotherapy treatments, will not be able to participate. Those who join the trial will have their health monitored closely, and samples of their blood and bone marrow will be stored for future research. This could help improve treatments for ALL in the future. If you or a loved one are considering this trial, it’s a chance to receive a promising treatment while contributing to important medical research.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria: Patients between 16 and 50 years-old with newly diagnosed ALL, negative for Philadelphia chromosome not previously treated (except for hydroxyurea, corticosteroids, or intrathecal chemotherapy) with 20% or more lymphoblasts in bone marrow or peripheral blood.
• Exclusion Criteria:
• • Burkitt leukemia
• • Prior myeloproliferative disease
• • Philadelphia chromosome positivity through whichever methodology (RT-PCR, FISH, or conventional karyotype)
• • ECOG\>2 (appendix 3)
• • Total bilirubin\>2x upper limit of normal (ULN)
• • Transaminases\>5x ULN
• • Creatinine\>2,5 mg/dl
• • Positive serology for HIV or HTLV
• • Heart failure NYHA Class III or IV (appendix 4)
• • Severe psychiatric disorder which prevents adequate compliance
• • Prior treatment with intravenous chemotherapy
• • Refusal to participate in the study
• • Down syndrome