Peripheral Blood Stem Cell Transplantation Using the CliniMACS Device

Study Overview
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Brief Summary
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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).

Official Title
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CHP 834 Unrelated and Partially Matched Related Donor Peripheral Stem Cell Transplantation With The CliniMACS Device for T and B Cell Depletion

Conditions
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Malignant Diseases (ie, Leukemia, MDS, Lymphoma), Non-malignant Diseases (ie, Bone Marrow Failure Syndromes)

Intervention / Treatment
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* Device: CliniMACS (CD+3, CD+19 depletion)
* Device: CliniMACS (CD 34+ positive selection)
* Other: HSCT


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stratum 1<br>Patients receiving an unrelated donor or partially matched related donor. | Device: CliniMACS (CD+3, CD+19 depletion)<br>* Patient's in Stratum 1 will receive grafts that have undergone CD3+, CD19+ depletion<br>Other: HSCT<br>* Peripheral Blood Stem Cell Transplant<br>|
| Experimental: Stratum 2<br>For the patient's whose donors are haploidentical or a 2 antigen mismatched where one of the mismatches includes DRB1 | Device: CliniMACS (CD 34+ positive selection)<br>* Patient's in Stratum 2 will receive peripheral blood progenitor cells that have undergone CD34+ selection<br>Other: HSCT<br>* Peripheral Blood Stem Cell Transplant<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To measure the incidence and quality of engraftment |  | Weekly for first 100 days, 6 months and 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Malignant and non-malignant diseases, Hematopoietic stem cell transplant, Peripheral blood progenitor cell transplant, CliniMACS device, T cell depletion