Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07258043

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

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Acute Lymphobkastic Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Overall Survival Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital General de México Dr. Eduardo Liceaga

Mexico City, 06720, Mexico

Location status: Recruiting

Location contact

Christian O Ramos, MD

CONTACT

[email protected]

55 2789 2000 ext. 52

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

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

Primary outcomes

  1. To determine the proportion of overall survival and disease-free survival

    Time frame: From enrollment until 1 year after the end of treatment.

    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.

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.

    Time frame: Complete Remision (CR) at 4 weeks after induction and measurable residual disease (MRD) at 6 weeks of treatment.

    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.

  2. 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.

    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.

  3. To describe the proportion of severe neutropenia events and treatment-related mortality

    Time frame: From enrollment until 1 year after the end of treatment.

    Neutropenia events associated with chemotherapy will be quantified in each cycle, and their proportion will be established per administered cycle

  4. 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).

    The days of hospital stay will be quantified for each cycle of chemotherapy.

Study contacts

Contact information is provided by the study sponsor or research team.

Christian O Ramos, MD

CONTACT

[email protected]

5523351588 ext. +52

Ernesto Villagran, MD

CONTACT

[email protected]

7771358561 ext. 52

Sponsors and collaborators

Lead sponsor

Hospital General de Mexico

Other Gov

Registry information

Official study title

Efficacy on Progression Free Overall Survival of a Dose-Adjusted Regimen in Frail Adult Patients With Acute Lymphoblastic Leukemia

Acronym: EPOCH

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 2, 2025
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.