NCT07258043

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 45 (estimated)
• Sponsor: Hospital General de Mexico · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Acute lymphoblastic leukemia (ALL) is characterized by the abnormal proliferation of immature precursor cells, disrupting normal hematopoiesis and causing severe anemia and thrombocytopenia due to genetic mutations. Conventional treatment with intensive chemotherapy is limited for elderly patients or those with comorbidities, adversely affecting their survival. In Mexico, alongside a higher incidence, treatment-related complications are more frequent, particularly with drugs such as asparaginase or anthracyclines, which limits therapeutic efficacy. The transition to infusion-based therapies promises to reduce these complications, improve treatment tolerance, and optimize clinical outcomes, marking a significant advancement in the management of this disease. Modifying treatment regimens toward infusion therapies has the potential to significantly reduce adverse complications, enhance treatment tolerance, and ultimately improve clinical outcomes for patients who cannot benefit from conventional intensive regimens. This approach not only aims to optimize treatment effectiveness but also to minimize associated risks, thus representing an important advancement in the management of acute lymphoblastic leukemia in clinical settings such as those in Mexico

Detailed description

The treatment of acute lymphoblastic leukemia (ALL) in adults represents a therapeutic challenge, particularly in patients with high-risk factors, clinical frailty, or socioeconomic limitations that hinder adherence to intensive outpatient regimens. While protocols such as HyperCVAD have been widely used, their toxicity can be significant in certain subgroups. In this context, the EPOCH regimen has been explored as an inpatient consolidation alternative that allows a gradual transition toward less toxic regimens, with potential benefits in vulnerable populations.

Conditions

• Acute Lymphobkastic Leukemia
• Leukemia
• Overall Survival

Interventions

Type	Name	Description
DRUG	Patients meeting criteria will receive DA-EPOCH via central line for 5 days every 21 days, with monitoring, supportive care, transfusions, prophylaxis, and G-CSF for 5 doses per cycle	After patient selection and confirmation of inclusion criteria, the DA-EPOCH treatment regimen will be initiated. It is typically administered through a central line over 5 days, during which adverse events will be closely monitored. Each treatment cycle lasts 21 days. All patients will receive the same level of care as those undergoing high-intensity chemotherapy, including monitoring of transfusion needs, supportive care with prophylactic medications, and the administration of colony-stimulating factors, with a total of 5 doses per cycle. The treatment regimen consists of six cycles, during which intrathecal chemotherapy will be administered to prevent central nervous system relapse. This prophylaxis will be given between each cycle. After completing the six cycles, patients will continue with a maintenance regimen consisting of 6-mercaptopurine at 50 mg/m² of body surface area from Monday to Friday, along with weekly intramuscular methotrexate (50 mg), total duration for 2 years

Timeline

• Start date: 2025-07-23
• Primary completion: 2026-07-23
• Completion: 2026-07-26
• First posted: 2025-12-02
• Last updated: 2025-12-02

Locations

1 site across 1 country: Mexico

Regulatory

• FDA-regulated drug study