NCT07258043 Efficacy of Dose-Adjusted Regimen on Survival in Frail Adults With Acute Lymphoblastic Leukemia
| NCT ID | NCT07258043 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospital General de Mexico |
| Condition | Acute Lymphobkastic Leukemia |
| Study Type | OBSERVATIONAL |
| Enrollment | 45 participants |
| Start Date | 2025-07-23 |
| Primary Completion | 2026-07-23 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 45 participants in total. It began in 2025-07-23 with a primary completion date of 2026-07-23.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
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
Contact & Investigator
Christian O Ramos, MD
PRINCIPAL INVESTIGATOR
Hospital General de México Dr. Eduardo Liceaga
Frequently Asked Questions
Who can join the NCT07258043 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Lymphobkastic Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07258043 currently recruiting?
Yes, NCT07258043 is actively recruiting participants. Contact the research team at leukemiachop33@gmail.com for enrollment information.
Where is the NCT07258043 trial being conducted?
This trial is being conducted at Mexico City, Mexico.
Who is sponsoring the NCT07258043 clinical trial?
NCT07258043 is sponsored by Hospital General de Mexico. The principal investigator is Christian O Ramos, MD at Hospital General de México Dr. Eduardo Liceaga. The trial plans to enroll 45 participants.
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