NCT07258043Recruiting
Efficacy of Dose-Adjusted Regimen on Survival in Frail Adults With Acute Lymphoblastic Leukemia
Efficacy on Progression Free Overall Survival of a Dose-Adjusted Regimen in Frail Adult Patients With Acute Lymphoblastic Leukemia
Source: ClinicalTrials.gov · Last updated 2 Dec 2025
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 45 (estimated)
- First submitted
- 27 Aug 2025
- Start date
- 23 Jul 2025
- Primary completion date
- 23 Jul 2026
- Lead sponsor
- Hospital General de Mexico
- Diseases
- Acute lymphoblastic leukaemia
- NCT number
- NCT07258043
What you commit to
- Study type: Observational
- Planned participants: 45
- From 23 Jul 2025 to the primary completion date, 23 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have previously received a low-intensity regimen due to comorbidities
- CNS involvement at diagnosis requiring radiotherapy
Other illness
- Patients with a history of ischemic or hemorrhagic stroke or severe neurological deterioration
Other
- ´- Patients refractory to induction treatment
- Biphenotypic leukemia
- Patients whose survival is expected to be less than 48 hours due to leukemiarelated complications
- Pregnant patients
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital General de México Dr. Eduardo Liceaga Coordinator of this site? Confirm its status | Mexico City | Mexico | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.