Status:
RECRUITING
Safety and Feasibility of TMLI as Conditioning Regimen in Allogeneic Hematopoietic Stem-cell Transplantation
Lead Sponsor:
Hospital Universitario Dr. Jose E. Gonzalez
Conditions:
Acute Lymphoblastic Leukemia
Eligibility:
All Genders
16-45 years
Phase:
NA
Brief 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 FORU...
Detailed Description
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 p...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2024
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT06209190
Start Date
September 1 2023
End Date
August 31 2024
Last Update
January 17 2024
Active Locations (1)
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1
Andres Gomez
Monterrey, Nuevo León, Mexico, 64710