Actively Recruiting

Age: 18Years +
All Genders
NCT07258043

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

Led by Hospital General de Mexico · Updated on 2025-12-02

45

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

´- 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

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Hospital General de México Dr. Eduardo Liceaga

Mexico City, Mexico City, Mexico, 06720

Actively Recruiting

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Research Team

C

Christian O Ramos, MD

CONTACT

E

Ernesto Villagran, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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