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

Hospital General de Mexico

Status: Enrolling

Conditions: Acute Lymphobkastic Leukemia; Overall Survival; Leukemia

Treatments: 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

Study type: Observational

Funder types: Other

Identifiers

NCT07258043

HGMexicoEduardoLiceaga

Details and patient eligibility

About

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

Full 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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with acute lymphoblastic leukemia (ALL) according to the World Health Organization (WHO) criteria
• Older than 18 years old
• ECOG Performance Status Scale >1 or the Karnofsky Performance Status (KPS) <80%.
• Comorbidities: diabetes mellitus, arterial hypertension, thrombotic events, endocrine disorders, or any condition that hinders the administration of full-dose chemotherapy.
• Toxicity prior to a standard chemotherapy regimen.
• Both genders
• Over 18 years of age
• No upper age limit
• Signed informed consent

Exclusion criteria

´- Patients refractory to induction treatment

• Patients who have previously received a low-intensity regimen due to comorbidities
• Biphenotypic leukemia
• CNS involvement at diagnosis requiring radiotherapy
• Patients whose survival is expected to be less than 48 hours due to leukemiarelated complications
• Patients with a history of ischemic or hemorrhagic stroke or severe neurological deterioration
• Pregnant patients

Trial design

45 participants in 1 patient group

Frail ALL patients by ECOG >1 or KPS <80%, or with severe toxicity from induction therapy

Description:

Patients newly diagnosed with acute lymphoblastic leukemia (ALL) who are considered clinically frail based on an ECOG performance status score greater than 1 or a Karnofsky score below 80%, indicating a high risk of severe chemotherapy-related toxicity. This group also includes patients who have previously received induction therapy and experienced severe, limiting toxicity that prevents continuation of intensive treatment regimens. These criteria identify a vulnerable population for whom standard chemotherapy may not be suitable, necessitating alternative, less intensive treatment approaches to reduce toxicity while maintaining therapeutic efficacy

Treatment:

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