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
This trial does not accept healthy volunteersQualifiers
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 population
Patients with a de novo diagnosis of acute lymphoblastic leukemia, considered frail according to the Eastern Cooperative Oncology Group (ECOG) Performance Status Scale or with a Karnofsky Performance Score below 80%, indicating a high risk of severe chemotherapy-related toxicity, or patients who have received induction therapy and experienced severe and limiting toxicity.
Trial design
Design model
Case-control
Time perspective
Prospective
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
DrugAfter 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
Treatment groups
45 Participants
are divided into 1 treatment groupGroup A: Frail ALL patients by ECOG >1 or KPS <80%, or with severe toxicity from induction therapy1 intervention
Trial outcomes
Primary outcomes
1
To determine the proportion of overall survival and disease-free survival
For the survival analysis, the Kaplan-Meier method will be used, which is a non-parametric technique employed to estimate the survival function from time-to-event data.
Time frame
From enrollment until 1 year after the end of treatment.Secondary outcomes
1
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.
Complete remission (CR) will be evaluated by bone marrow aspiration and optical microscopy review at 4 weeks after induction, while measurable residual disease (MRD) will be assessed also by bone marrow aspiration ans measured by flow cytometry at 6 weeks of treatment.
Time frame
Complete Remision (CR) at 4 weeks after induction and measurable residual disease (MRD) at 6 weeks of treatment.2
To establish the proportion of serious adverse events associated with the chemotherapy regimen.
These will be graded according to the adverse events scale. The National Comprehensive Cancer Network (NCCN) adverse events scale, known as the 'NCCN Common Terminology Criteria for Adverse Events' (NCCN CTCAE), is a tool used to classify the severity of adverse events that occur during clinical trials of cancer treatments.
Time frame
From enrollment until 1 year after the end of treatment.3
To describe the proportion of severe neutropenia events and treatment-related mortality
Neutropenia events associated with chemotherapy will be quantified in each cycle, and their proportion will be established per administered cycle
Time frame
From enrollment until 1 year after the end of treatment.4
To describe the length of hospital stay in days.
The days of hospital stay will be quantified for each cycle of chemotherapy.
Time frame
From hospital admission to the last day of stay for each administered cycle (each cycle is 21 days).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Hospital General de Mexico
Lead sponsor
Hospital General de México Dr. Eduardo Liceaga
Sponsor institution
Source ClinicalTrials.gov