An interventional study of total marrow and total lymphoid irradiation in Acute Lymphoblastic Leukemia, sponsored by Hospital Universitario Dr. Jose E. Gonzalez. Completed at 1 site in Mexico. Open to participants aged 16 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-03-25.
Sponsored by Hospital Universitario Dr. Jose E. Gonzalez · Not applicable, Interventional, and Treatment
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).
TMLI will be administered as part of the conventional reduced intensity conditioning scheme of our institution:
Fludarabine 25 mg/m2 + cyclophosphamide 350 mg/m2 on days -6 to -3, for patients with positive measurable residual disease TMLI will be added in doses of 12 Gy on days -3 to -1 divided into 6 fractions of 2 Gy every 12 hours for 3 days, which will be administered through a computed tomography tomotherapy system.
Infusion of peripheral blood hematopoietic stem cells will be performed on day 0 and after this, prophylaxis for GVHD with post-transplant cyclophosphamide 50 mg/kg will be administered on days +3 and +4, followed by tacrolimus or cyclosporine A plus mycophenolate mofetil regardless of HLA matching.
The procedure for the donation of hematopoietic cells will be done through a peripheral blood apheresis with previous stimulation with filgrastim at 10 mcg/kg for 4 days according to the standardized procedures of our institution.
The leukocyte and platelet count will be monitored by serial complete blood count, and a bone marrow aspiration (BMA) and minimal residual disease (MRD) will be performed on day 60 after transplantation.
2,061 studies on the registry are indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma; 490 are open to participants now.
This study's enrollment of 14 is below the median of 40 across 1,653 interventional studies indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma.
Browse Precursor Cell Lymphoblastic Leukemia-Lymphoma studies →Hospital Universitario Dr. Jose E. Gonzalez is the lead sponsor of 79 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
TMLI will be added in doses of 12 Gy on days -3 to -1 divided into 6 fractions of 2 Gy every 12 hours for 3 days, which will be administered through a computed tomography tomotherapy system.
Radiation: total marrow and total lymphoid irradiation
doses of 12 Gy on days -3 to -1 divided into 6 fractions of 2 Gy every 12 hours for 3 days, which will be administered through a computed tomography tomotherapy system plus conditioning scheme of our institution
Early mortality rate
Primary outcome of safety will be determined by early mortality rate (before day +30) with an expected rate lower than 15%.
Time frame: 30 days
Serious adverse events
Co-primary outcome will be the appearance of serious adverse effects (grade equal to or higher than 3) according to the common terminology criteria for adverse events of the US National Cancer Institute (NCL-CTCAE v.5).
Time frame: 30 days
Measurable residual disease
Measurable residual disease assessment through flow cytometry in bone marrow aspirate
Time frame: 60 days
Non-relapse mortality
Event of death in patients without disease relapse with death after relapse as a competing risk.
Time frame: 12 months
Event-free survival
Survival without event of disease progression, relapse or death after enrollment.
Time frame: 12 months
Overall survival
Survival time after enrollment
Time frame: 12 months
Graft versus host disease incidence
Incidence of graft versus host disease according to MAGIC and NIH criteria
Time frame: 12 months
Plan to share: No
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Hospital Universitario Dr. Jose E. Gonzalez