Trial Summary
What is the purpose of this trial?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.
Eligibility Criteria
This trial is for patients under 23 years old with various blood cancers, including lymphoma and leukemia, who are in remission or have less than 10% bone marrow blasts. It's open to all genders and races but excludes those without a suitable donor or who don't meet specific disease, organ function, or infection criteria.Inclusion Criteria
I am younger than 23 years old.
My condition is acute myeloid leukemia.
My condition is in a specific phase of chronic illness.
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Exclusion Criteria
There is no available person who can donate what is needed for the study.
My condition does not match the specific disease, organ, or infection criteria.
Participant Groups
The study tests the CliniMACS device's ability to deplete Alpha Beta T cells plus CD19+ B cells from stem cell transplants in patients with blood cancers using alternative donors. The goal is to see how well it works by looking at engraftment success, avoidance of GVHD (graft-versus-host disease), and one-year survival without leukemia.
1Treatment groups
Experimental Treatment
Group I: Single Experimental ArmExperimental Treatment1 Intervention
Alpha Beta T cell depletion is performed for all PBSC grafts using the CliniMACs device
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Children's Hospital of WisconsinMilwaukee, WI
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Who Is Running the Clinical Trial?
Julie-An M. TalanoLead Sponsor
Miltenyi Biotec, Inc.Industry Sponsor