Dose-adjusted EPOCH infusions for frail adults with acute lymphoblastic leukemia
Official title: Efficacy on Progression Free Overall Survival of a Dose-Adjusted Regimen in Frail Adult Patients With Acute Lymphoblastic Leukemia
Run by Hospital General de Mexico · NCT07258043 · Data updated 2026-11-12
This project will see if a dose-adjusted, infusion-based EPOCH chemotherapy regimen helps frail adults with acute lymphoblastic leukemia tolerate treatment better and live longer.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 45 (estimated) |
| Sponsor | Hospital General de Mexico Government |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Mexico City, Mexico City) |
| Status | Recruiting |
| Started | July 23, 2025 |
| Main results expected | July 23, 2026 |
| Study ends | July 26, 2026 |
| Registry record updated | December 2, 2025 |
| Trial ID | NCT07258043 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with ALL who are considered frail (ECOG >1 or KPS <80) or have comorbidities that prevent full-dose chemotherapy and who can be admitted for inpatient DA-EPOCH at the Mexico City center.
✕Probably not a fit
Patients with refractory disease, biphenotypic leukemia, CNS involvement requiring radiotherapy, expected survival under 48 hours, recent severe stroke or marked neurological decline, or pregnancy are unlikely to benefit from this regimen.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study follows frail adults with ALL treated with dose-adjusted EPOCH given by continuous infusion for five days every 21 days through a central line. Patients receive monitoring and supportive care including transfusions, prophylaxis, and five doses of G-CSF per cycle while clinicians record toxicity, adherence, and clinical outcomes. The primary focus is overall survival and treatment-related complications in a population unable to tolerate intensive outpatient chemotherapy. The study is conducted at Hospital General de México and compares outcomes to historical or expected results from standard regimens.
Why it matters
Potential benefit: If successful, this approach could reduce treatment-related complications and improve treatment tolerance and survival for frail adults with ALL who cannot receive standard intensive chemotherapy.
How similar studies have gone: DA-EPOCH and infusion-based regimens have been used in other hematologic malignancies and explored as a lower-toxicity option in vulnerable ALL patients, but randomized evidence in this specific frail adult ALL population remains limited.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Hospital General de México Dr. Eduardo Liceaga
Mexico City, Mexico City, Mexico Recruiting
Study contacts
- Principal investigator: Christian O Ramos, MD — Hospital General de México Dr. Eduardo Liceaga
- Study coordinator: Christian O Ramos, MD
- Email: leukemiachop33@gmail.com
- Phone: 5523351588
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.