Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226, United States
NCT Number: NCT02600208
This is a single arm pilot study for patients with hematologic malignancies with alternative donor sources receiving unrelated or partially matched related/Haploidentical mobilized peripheral stem cells (PSCs) using the CliniMACS system for Alpha Beta T cell depletion plus CD19+ B cell depletion to determine efficacy as determined by engraftment and GVHD, and one year leukemia free survival.
This study is active but is not currently recruiting participants.
Notify MeUp to 23 year
Female
Interventional
Phase 2
Milwaukee, Wisconsin, 53226, United States
The purpose of this research study is to evaluate a new method of T cell depletion using the Miltenyi CliniMACS™ device for patients undergoing a peripheral stem cell transplant utilizing either a unrelated donor or partially matched/haploidentical related donor. This new method is called α/β (alpha/beta) T cell depletion and CD19+ B cell depletion. This pilot study will evaluate if this new method of T cell and B cell depletion is a more effective way of removing T cells thus reducing the risk of severe acute and chronic GVHD and result in a durable engraftment.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patient:
Leukemias/lymphomas:
Exclusion criteria
Depletion of Alpha Beta T cells in the PBSC graft
Other names: Alpha/Beta T-Cell Depletion
Time frame: DAY 42
Engraftment will be defined using the standard CIBMTR definition of ANC >500 for the first of 3 consecutive days.
Time frame: 1 year
Leukemia relapse is defined as presence of malignant cells in the blood or other body site after initiation of conditioning in a patient previously in remission.
Time frame: 1 year
Acute GVHD will be graded using the standard Glucksberg grading system.
Time frame: 1 year
TRM is defined as death from non-disease related causes in the 100 days from stem cell infusion.
Julie-An M. Talano
Other
BT13BTθ51 Unrelated and Partially Matched Related Donor Peripheral Stem Cell Transplantation With Alpha Beta T Cell and B Cell Depletion For Patients With Hematologic Malignancies
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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.
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