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

NCT07258043 | Recruiting DMC FDA Drug

• 1 other identifier: HGMexicoEduardoLiceaga
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acute Lymphobkastic Leukemia; Leukemia; Overall Survival

Keywords

acute lymphoblastic leukemia; EPOCH

Outcome Measures

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.

  From enrollment until 1 year after the end of treatment.

Secondary Outcomes (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.

  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.

  From enrollment until 1 year after the end of treatment.

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

  From enrollment until 1 year after the end of treatment.

• To describe the length of hospital stay in days.

  From hospital admission to the last day of stay for each administered cycle (each cycle is 21 days).

Study Arms (1)

Frail ALL patients by ECOG >1 or KPS <80%, or with severe toxicity from induction therapy

Patients newly diagnosed with acute lymphoblastic leukemia (ALL) who are considered clinically frail based on an ECOG performance status score greater than 1 or a Karnofsky score below 80%, indicating a high risk of severe chemotherapy-related toxicity. This group also includes patients who have previously received induction therapy and experienced severe, limiting toxicity that prevents continuation of intensive treatment regimens. These criteria identify a vulnerable population for whom standard chemotherapy may not be suitable, necessitating alternative, less intensive treatment approaches to reduce toxicity while maintaining therapeutic efficacy

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

Interventions

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

Frail ALL patients by ECOG >1 or KPS <80%, or with severe toxicity from induction therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• ´- 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

Sponsors & Collaborators

• Hospital General de Mexico: lead

Study Sites (1)

Hospital General de México Dr. Eduardo Liceaga

Mexico City, Mexico City, 06720, Mexico

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Bone marrow biopsy will be retained

MeSH Terms

Conditions

Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Palliative Care; Blood Transfusion; Granulocyte Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Biological Therapy; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Christian O Ramos, MD

  Hospital General de México Dr. Eduardo Liceaga

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christian O Ramos, MD

CONTACT

5523351588; leukemiachop33@gmail.com

Ernesto Villagran, MD

CONTACT

7771358561; nerev16@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: August 27, 2025
• First Posted: December 2, 2025
• Study Start: July 23, 2025
• Primary Completion (Estimated): July 23, 2026
• Study Completion (Estimated): July 26, 2026
• Last Updated: December 2, 2025

Record last verified: 2025-09

Locations

ME (1)