Peripheral Blood Stem Cell Transplantation Using the CliniMACS Device
Not Applicable
Completed
- Conditions
- Malignant Diseases (ie, Leukemia, MDS, Lymphoma)Non-malignant Diseases (ie, Bone Marrow Failure Syndromes)
- Registration Number
- NCT01071226
- Lead Sponsor
- Medical College of Wisconsin
- Brief Summary
T cell depletion utilizing the CliniMACS device will allow more precise, specific and controlled graft engineering of peripheral blood stem cells from unrelated and partially matched related donors without an increase in relapse or graft rejection and grade III or IV acute graft versus host disease (GVHD).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
- All races are eligible
- Malignant diseases: Leukemias and Lymphomas
- Non-malignant diseases: Severe Aplastic Anemia, immunodeficiencies
Exclusion Criteria
- Lansky or Karnofsky > 70
- Echo > 27% shortening fraction
- renal function:serum creatinine < 1.5 x for normal age
- no active untreated infection
- DLCO > 50% of predicted value
- Hepatic: AST and ALT < 3x upper limit of normal; bilirubin < 2.0.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method To measure the incidence and quality of engraftment Weekly for first 100 days, 6 months and 1 year
- Secondary Outcome Measures
Name Time Method Evaluate the incidence of acute Graft versus Health Disease and treatment related mortality. weekly for the first 100 days and then 6 and 12 months post transplant date
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms enable CliniMACS-mediated T and B cell depletion to reduce acute GVHD without increasing relapse rates in allogeneic stem cell transplantation?
How does T cell depletion using the CliniMACS device compare to standard-of-care methods in terms of graft rejection rates and engraftment kinetics for unrelated donor transplants?
Which biomarkers are associated with successful engraftment and minimal GVHD following CD34+ selected peripheral blood stem cell transplantation with the CliniMACS device?
What are the long-term adverse event profiles of patients undergoing T and B cell depletion with the CliniMACS device in NCT01071226?
How do CliniMACS-based graft engineering strategies compare to other T cell depletion technologies in treating hematologic malignancies like leukemia and lymphoma?
Trial Locations
- Locations (1)
Children's Hospital of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Children's Hospital of Wisconsin🇺🇸Milwaukee, Wisconsin, United States