Efficacy of Dose-Adjusted Regimen on Survival in Frail Adults With Acute Lymphoblastic Leukemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 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.
- Who it may be relevant to
- Registry conditions: Acute Lymphobkastic Leukemia, Leukemia, Overall Survival. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Mexico
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Efficacy on Progression Free Overall Survival of a Dose-Adjusted Regimen in Frail Adult Patients With Acute Lymphoblastic Leukemia
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
Detailed 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.
Interventions
- 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
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-stimulati
Primary outcome measures
- To determine the proportion of overall survival and disease-free survival [Time frame: From enrollment until 1 year after the end of treatment.]
Secondary outcome measures (4)
- To determine the proportion of complete remissions (<5% blasts per field) after the first 4 weeks of induction therapy and the proportion of measurable residual disease (proportion of cells) at 6 weeks. [Time frame: Complete Remision (CR) at 4 weeks after induction and measurable residual disease (MRD) at 6 weeks of treatment.]
- To establish the proportion of serious adverse events associated with the chemotherapy regimen. [Time frame: From enrollment until 1 year after the end of treatment.]
- To describe the proportion of severe neutropenia events and treatment-related mortality [Time frame: From enrollment until 1 year after the end of treatment.]
- To describe the length of hospital stay in days. [Time frame: From hospital admission to the last day of stay for each administered cycle (each cycle is 21 days).]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Mexico · 1 center
- Hospital General de México Dr. Eduardo Liceaga — Mexico City
Identifiers
NCT: NCT07258043 · HGMexicoEduardoLiceaga