RecruitingNCT07258043

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

Sponsor

Hospital General de Mexico

Enrollment

45 participants

Start Date

Jul 23, 2025

Study Type

OBSERVATIONAL

Conditions

Leukemia Overall Survival Acute Lymphobkastic Leukemia

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

Eligibility

Min Age: 18 Years

Inclusion Criteria9

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 Criteria7

´- 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

Interventions

DRUGPatients 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