Efficacy of Dose-Adjusted Regimen on Survival in Frail Adults With Acute Lymphoblastic Leukemia
Recruiting now
Conditions studied: Acute Lymphobkastic Leukemia, Leukemia, Overall Survival
In brief
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
Key facts
- Study ID
- NCT07258043
- Run by
- Hospital General de Mexico
- People needed
- 45
- Starts
- 2025-07-23
- Expected to finish
- 2026-07-26
- Last updated by the study team
- 2025-12-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Hospital General de México Dr. Eduardo Liceaga — Mexico City, Mexico City, Mexico (enrolling)
Full record on ClinicalTrials.gov
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