This is a single arm, phase II trial of HLA-haploidentical related hematopoietic cells transplant (Haplo-HCT) using reduced intensity conditioning (fludarabine and melphalan and total body irradiation). Peripheral blood is the donor graft source. This study is designed to estimate disease-free survival (DFS) at 18 months post-transplant.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
34
Fludarabine 30mg/m\^2/day will be administered over 30-60 minutes intravenous infusion on Days -6 through -2 for a total dose of 150 mg/m\^2
Melphalan 70 mg/m\^2 over 45 minutes will be administered Day -6. Melphalan dose will be calculated based on Actual Body Weight.
Total Body Irradiation (TBI) will be delivered at a dose of 200 centigray units (cGy)
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States
Disease Free Survival
Disease Free Survival (DFS) is defined as the time from the date of Peripheral Blood Stem Cell Transplant (PBSCT) to first documentation of relapse or death due to any cause, whichever comes first.
Time frame: Up to 18 months post-transplant
Percentage of Participants With Graft vs Host Disease (GVHD) Free Survival
GVHD-free survival is defined as the time from the date of PBSCT to date of events which include grade III-IV acute GVHD and systemic therapy-requiring chronic GVHD.
Time frame: At 180 days post-transplant
Percentage of Participants Overall Survival (OS)
OS is defined as the time from the date of PBSCT to the date of death due to any cause.
Time frame: Up to 18 months
Percentage of Participants With Treatment Related Mortality (TRM) at 6 Months
TRM is defined as death not directly due to disease
Time frame: at 6 months post-transplant
Percentage of Participants With Treatment Related Mortality (TRM) at 18 Months
TRM is defined as death not directly due to disease
Time frame: at 18 months post-transplant
Percentage of Participants With Relapse Free Survival (RFS)
RFS is defined as the time from the date of PBSCT to relapse or death.
Time frame: Up to 18 months post-transplant
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