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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Mexico
Hospital General de México Dr. Eduardo Liceaga
RECRUITING
Mexico City
Contact Information
Primary
Christian O Ramos, MD
leukemiachop33@gmail.com
5523351588
Backup
Ernesto Villagran, MD
nerev16@gmail.com
7771358561
Time Frame
Start Date: 2025-07-23
Estimated Completion Date: 2026-07-26
Participants
Target number of participants: 45
Treatments
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
Sponsors
Leads: Hospital General de Mexico

This content was sourced from clinicaltrials.gov

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