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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHospital General de Mexico

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • 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

Treatment groups

45 Participants
are divided into 1 treatment group

Sponsors and collaborators

Hospital General de Mexico

Lead sponsor

Hospital General de México Dr. Eduardo Liceaga

Sponsor institution