Efficacy on Progression Free Overall Survival of a Dose-Adjusted Regimen in Frail Adult Patients With Acute Lymphoblastic Leukemia

What this Trial Is About

Researchers are evaluating a dose-adjusted chemotherapy regimen for adults with acute lymphoblastic leukemia (ALL) who are considered frail due to poor performance status or severe toxicity from prior treatments. This trial focuses on patients who face challenges with intensive chemotherapy, aiming to improve survival and reduce treatment complications, especially in settings like Mexico where treatment-related risks are higher. The study examines whether this approach can better manage the disease while minimizing side effects in vulnerable patients. Participants will receive the DA-EPOCH chemotherapy regimen administered via a central line over 5 days every 21 days for six cycles. Supportive care including transfusions, prophylaxis, and colony-stimulating factors are provided alongside treatment. Between cycles, intrathecal chemotherapy is given to prevent central nervous system relapse. After the six cycles, patients continue with a maintenance phase using oral 6-mercaptopurine and weekly methotrexate injections for two years. During the study, patients will be closely monitored for adverse events, transfusion needs, and overall treatment tolerance. Outcomes measured include overall survival, disease-free survival, remission rates, measurable residual disease, serious adverse events, neutropenia, treatment-related mortality, and hospital stay length. Follow-up extends from enrollment through one year after treatment completion to assess both effectiveness and safety of the regimen.

Efficacy of Dose-Adjusted Regimen on Survival in Frail Adults With Acute Lymphoblastic Leukemia