To determine engraftment of neutrophils and platelets at 28 days following alpha/beta T-cell and CD19 cell depletion using Human Leukocyte Antigen (HLA) haploidentical donors for peripheral blood stem cell transplant in relapsed lymphoma. Assess incidence of acute Graft Versus Host Disease (GVHD), chronic GVHD, graft failure rate, treatment related mortality rate, progression free survival and overall survival of patients. The stem cell product will be processed using an investigational Miltenyi cell selection device/system that removes the alpha/beta T-cells and CD19+ cells, immune system cells that are more likely to cause GVHD.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
11
Fludarabine will be administered by IV over approximately 30 minutes for 4 days.
Given IV over 24 hours starting prior to cyclophosphamide
Given IV for 2 days
Undergo total lymphoid irradiation
Undergo TCR alpha-beta/DC19-depleted hematopoietic stem cell transplant
Undergo TCR alpha-beta/DC19-depleted hematopoietic stem cell transplant
Undergo TCR alpha-beta/CD19-depleted hematopoietic stem cell transplant
Given PO
Given PO or IV ONLY if graft cell content is over 1 x 10\^5 cells/kg ideal BW of the patient
Given IV ONLY if graft B cell content exceeds 1 x 10\^5 cells/kg ideal BW of the patient
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States
Number of Participants With Absolute Neutrophil Count >= 500/Mcl for 3 Consecutive Measurements on Different Days and Platelet Count > 20,000/mm^3 With no Platelet Transfusions in the Preceding 7 Days
To determine engraftment of neutrophils and platelets at 28 days following alpha/beta T-cell depletion using Human Leukocyte Antigen (HLA) haploidentical donors for stem cell transplant in relapsed lymphoma.
Time frame: At day 28 after transplantation
Number of Participants With Grade III-IV Acute GVHD as Determined by International Bone Marrow Transplant Registry (IBMTR) Severity Index Criteria
The number of participants with grade III - IV acute Graft versus host disease (GVHD) by Day +100 is reported.
Time frame: Day +100
Number of Participants With Severe Chronic GVHD
The number of participants with severe chronic GVHD by Day +180 will be reported.
Time frame: Day +180
Number of Participants With Graft Failure
Graft failure - defined as \< 5% donor chimerism in the CD3 and/or CD33 selected cell populations at any time during the study follow up period once initial engraftment has been achieved.
Time frame: Up to 2 years after graft
Number of Participants With Treatment-related Mortality
Treatment-related mortality is defined as death from any cause other than disease progression.
Time frame: Up to 2 years after graft
Progression-free Survival
Progression-free survival will be analyzed as time before any progression by either Positron Emission Tomography/Computed Tomography (PET/CT) or bone marrow,
Time frame: Median follow up of 1689 days
Overall Survival (OS)
Time frame: Median follow up of 1689 days
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