Peripheral Blood Stem Cell Transplantation Using the CliniMACS Device
This trial is active, not recruiting.
|Conditions||malignant diseases (ie, leukemia, mds, lymphoma), non-malignant diseases (ie, bone marrow failure syndromes)|
|Treatments||clinimacs (cd+3, cd+19 depletion), clinimacs (cd 34+ positive selection)|
|Sponsor||Medical College of Wisconsin|
|Collaborator||Children's Hospital of Philadelphia|
|Start date||May 2008|
|End date||December 2016|
|Trial size||60 participants|
|Trial identifier||NCT01071226, CHOP 07/216|
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).
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
To measure the incidence and quality of engraftment
time frame: Weekly for first 100 days, 6 months and 1 year
Evaluate the incidence of acute Graft versus Health Disease and treatment related mortality.
time frame: weekly for the first 100 days and then 6 and 12 months post transplant date
Male or female participants up to 22 years old.
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.
|Official title||CHP 834 Unrelated and Partially Matched Related Donor Peripheral Stem Cell Transplantation With The CliniMACS Device for T and B Cell Depletion|
|Principal investigator||Julie A Talano, MD|
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