Safety and Feasibility of Total Marrow and Total Lymphoid Irradiation as Conditioning Regimen in Allogeneic Hematopoietic Stem-cell Transplantation

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Maximum Age: 45
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Mexico
Andres Gomez
RECRUITING
Monterrey
Contact Information
Primary
Andrés Gómez-De León, MD
drgomezdeleon@gmail.com
+52833338111
Backup
Perla R Colunga-Pedraza, MD
colunga.perla@gmail.com
+528116089404
Time Frame
Start Date: 2023-09-01
Estimated Completion Date: 2024-08-31
Participants
Target number of participants: 14
Treatments
Experimental: Total marrow and lymphoid irradiation (TMLI)
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.
Sponsors
Leads: Hospital Universitario Dr. Jose E. Gonzalez

This content was sourced from clinicaltrials.gov

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