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

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

Recruiting
18 years and older
All
Phase N/A

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Overview

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

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.

Eligibility

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:

ยด- 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

Study details
    Acute Lymphobkastic Leukemia
    Leukemia
    Overall Survival

NCT07258043

Hospital General de Mexico

31 January 2026

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