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

Recruitingn/aAges 18 Years - anyAllHospital General de Mexico
NCT07258043 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 trea

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📋 Eligibility rules (as published)
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
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What it tests

  • 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
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Where

1 site
Hospital General de México Dr. Eduardo Liceaga
Mexico City, Mexico
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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