The goal of this research is to test if the conditioning regimen, fludarabine and total body irradiation (FluTBI), can lead to a safer and more effective stem cell transplant treatment regimen for ALL patients older than 40 years of age and/or younger patients with high risk medical conditions. The primary objective is to establish the efficacy of allo HCT in older ALL patients using myeloablative FluTBI conditioning regimen. The investigators are also assessing the safety and toxicity of allo HCT in older ALL patients using myeloablative FluTBI conditioning regimen.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
19
UAB Bone Marrow Transplantation and Cellular Therapy Program
Birmingham, Alabama, United States
Percentage of Subjects Disease-free Survival
Percentage of patients without relapse of disease at 2 years
Time frame: 2 years post-transplant
Percentage of Subjects That Survived
Time frame: 2 years post-transplant
Time to Neutrophil Engraftment
Neutrophil engraftment is defined as the first of 3 consecutive days with an absolute neutrophil count (ANC) \> 500/μL. Measuring the number of days it takes for (ANC) \> 500/μL.
Time frame: Within the first 100 days
Number of Subjects With Regimen Related Toxicity
Time frame: Within first 100 days post-transplant
Percentage of Subjects With Acute GVHD
Time frame: 2 years post transplant
Number of Patients With Immune Reconstitution
Time frame: 1 year post transplant
Percentage of Subjects With Relapse
Time frame: 2 Years post-transplant
Number of Subjects With Platelet Engraftment
Platelet engraftment is defined as the first of 3 consecutive days with a platelet count \> 20,000/μL without platelet transfusion for 7 days.
Time frame: Within 100 days post transplant
Percentage of Subjects With Chronic GVHD
Time frame: 2 years post transplant
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