Using total marrow and lymphoid irradiation for stem cell transplantation in leukemia patients
Safety and Feasibility of Total Marrow and Total Lymphoid Irradiation as Conditioning Regimen in Allogeneic Hematopoietic Stem-cell Transplantation
This study is testing if a new type of radiation treatment can make stem cell transplants safer and more effective for young adults with acute lymphoblastic leukemia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 14 (estimated) |
| Ages | 16 Years to 45 Years |
| Sex | All |
| Sponsor | Hospital Universitario Dr. Jose E. Gonzalez Academic / other |
| Drugs / interventions | chemotherapy, radiation, cyclophosphamide, Fludarabine |
| Locations | 1 site (Monterrey, Nuevo LEON) |
| Trial ID | NCT06209190 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and feasibility of total marrow and lymphoid irradiation (TMLI) as a conditioning regimen for allogeneic hematopoietic stem cell transplantation (HSCT) in patients aged 16 to 45 with acute lymphoblastic leukemia (ALL). The study involves administering TMLI alongside fludarabine and cyclophosphamide, with the goal of reducing long-term toxicity associated with traditional total body irradiation. Secondary endpoints include assessing minimal residual disease, non-relapse mortality, relapse-free survival, and overall survival at 60 days post-transplant. The trial aims to determine if TMLI can maintain the benefits of radiation while minimizing harm to healthy tissues.
Who should consider this trial
Good fit: Ideal candidates are patients aged 16 to 45 with a confirmed diagnosis of acute lymphoblastic leukemia in first remission, refractory, or relapsing stages who have a suitable allogeneic donor.
Not a fit: Patients over 45 years old, those with significant comorbidities, or individuals who have previously received radiotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to safer and more effective treatment options for patients undergoing stem cell transplantation for leukemia.
How similar studies have performed: While total body irradiation has been widely used, TMLI is a newer approach, and its success in this context is still being evaluated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of ALL confirmed by flow cytometry. * Patients between age 16 and 45 years with ALL in first remission, refractory, or relapsing * Patients who have an identical or haploidentical allogeneic donor by high resolution HLA Exclusion Criteria: * Patients who do not meet the age previously mentioned. * Patient with comorbidities that rule them out for HSCT, with a Hematopoietic cell transplantation-specific comorbidity index (HCT-CI) greater than 2. * Poor performance status or Karnofsky less than 70% * Transthoracic echocardiogram with alteration in myocardial function with left ventricular ejection fraction (LVEF) less than 50% * Patients who previously and for another reason have already received radiotherapy or who refuse to receive it
Where this trial is running
Monterrey, Nuevo LEON
- Andres Gomez — Monterrey, Nuevo LEON, Mexico (Recruiting)
Study contacts
- Study coordinator: Andrés Gómez-De León, MD
- Email: drgomezdeleon@gmail.com
- Phone: +52833338111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.