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)
- Interventions
- Device: CliniMACS (CD+3, CD+19 depletion)Device: CliniMACS (CD 34+ positive selection)Other: HSCT
- 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
- Arm && Interventions
Group Intervention Description Stratum 1 HSCT Patients receiving an unrelated donor or partially matched related donor. Stratum 1 CliniMACS (CD+3, CD+19 depletion) Patients receiving an unrelated donor or partially matched related donor. Stratum 2 CliniMACS (CD 34+ positive selection) For the patient's whose donors are haploidentical or a 2 antigen mismatched where one of the mismatches includes DRB1 Stratum 2 HSCT For the patient's whose donors are haploidentical or a 2 antigen mismatched where one of the mismatches includes DRB1
- 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
Trial Locations
- Locations (1)
Children's Hospital of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States