NCT06209190Completed
Safety and Feasibility of TMLI as Conditioning Regimen in Allogeneic Hematopoietic Stem-cell Transplantation
Safety and Feasibility of Total Marrow and Total Lymphoid Irradiation as Conditioning Regimen in Allogeneic Hematopoietic Stem-cell Transplantation
Source: ClinicalTrials.gov · Last updated 25 Mar 2026
Brief summary (registry, in English)
Multiple conditioning regimens have been used for the HSCT, some of which include radiotherapy. Total body irradiation (TBI) has demonstrated to be superior to chemotherapy alone in the phase III FORUM trial. However, concerns for long-term toxicity have made TBI less used. Total marrow and lymphoid irradiation (TMLI) has emerged as a new alternative that can potentially keep the benefits of radiation but reducing toxicity to healthy tissues. The primary objective of this trial is to evaluate the feasibility and safety of TMLI as part of conditioning schemes with or without etoposide for HSCT in patients between age 16 and 45 years with ALL in first line or relapsed disease. As secondary endpoint the efficacy will be assessed by minimal residual disease at 60 days post-transplant, as well as other outcome measures such as non-relapse mortality (NRM), relapse free survival (RFS) and overall survival (OS).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 14 (actual)
- First submitted
- 31 Aug 2023
- Start date
- 1 Sept 2023
- Primary completion date
- 4 Dec 2024
- Lead sponsor
- Hospital Universitario Dr. Jose E. Gonzalez
- NCT number
- NCT06209190
What you commit to
- Study type: Interventional
- Participants enrolled: 14
- From 1 Sept 2023 to the primary completion date, 4 Dec 2024
- 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 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.
- Patients who previously and for another reason have already received radiotherapy or who refuse to receive it
Lab values
- Transthoracic echocardiogram with alteration in myocardial function with left ventricular ejection fraction (LVEF) less than 50%
Other
- Poor performance status or Karnofsky less than 70%
Who the study is looking for
- 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
Age in the registry: 16 years to 45 years · 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 |
|---|---|---|---|
| Andres Gomez Coordinator of this site? Confirm its status | Monterrey | Mexico | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.