University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53705, United States
NCT Number: NCT02652468
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.
Looking for future studies?
Notify Me18 year–75 year
All sexes
Interventional
Not applicable
Madison, Wisconsin, 53705, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Other names: HSC, HSCT
Undergo TCR alpha-beta/CD19-depleted hematopoietic stem cell transplant
Given PO
Other names: MMF
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
Time frame: At day 28 after transplantation
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: Day +100
The number of participants with grade III - IV acute Graft versus host disease (GVHD) by Day +100 is reported.
Time frame: Day +180
The number of participants with severe chronic GVHD by Day +180 will be reported.
Time frame: Up to 2 years after graft
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
Treatment-related mortality is defined as death from any cause other than disease progression.
Time frame: Median follow up of 1689 days
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
University of Wisconsin, Madison
Other
A Pilot Study to Assess Engraftment Using CliniMACS TCR-α/β and CD19 Depleted Stem Cell Grafts From Haploidentical Donors for Hematopoietic Progenitor Cell Transplantation (HSCT) in Patients With Relapsed Lymphoma
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03480360
Acute Myeloid Leukemia, Anemia
Lebanon, New Hampshire, United States
View Trial DetailsNCT01563874
Hemic and Lymphatic Diseases, Immune System Diseases
Bethesda, Maryland, United States
View Trial DetailsNCT04837222
Hemic and Lymphatic Diseases, Immune System Diseases
Hefei, Anhui, China
View Trial DetailsNCT04737265
Breast Cancer, Breast Diseases
Duarte, California, United States
View Trial Details