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| Name | Class |
|---|---|
| Miltenyi Biotec, Inc. | INDUSTRY |
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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.
The purpose of this research study is to evaluate a new method of T cell depletion using the Miltenyi CliniMACS™ device for patients undergoing a peripheral stem cell transplant utilizing either a unrelated donor or partially matched/haploidentical related donor. This new method is called α/β (alpha/beta) T cell depletion and CD19+ B cell depletion. This pilot study will evaluate if this new method of T cell and B cell depletion is a more effective way of removing T cells thus reducing the risk of severe acute and chronic GVHD and result in a durable engraftment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Experimental Arm | Experimental | Alpha Beta T cell depletion is performed for all PBSC grafts using the CliniMACs device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CliniMACs | Device | Depletion of Alpha Beta T cells in the PBSC graft |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the engraftment of patients receiving unrelated donor or partially matched related donor peripheral stem cells that have T cell depleted and CD19+ B cell depleted using the CliniMACS device. | Engraftment will be defined using the standard CIBMTR definition of ANC >500 for the first of 3 consecutive days. | DAY 42 |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the probability of one year leukemia free survival (LFS). | Leukemia relapse is defined as presence of malignant cells in the blood or other body site after initiation of conditioning in a patient previously in remission. | 1 year |
| Estimate the incidence and extent of acute and chronic graft vs. host disease. |
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Inclusion Criteria:
Patient:
Leukemias/lymphomas:
Exclusion Criteria:
Patient
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| Name | Affiliation | Role |
|---|---|---|
| Julie-An Talano, MD | Medical College of Wisconsin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
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Acute GVHD will be graded using the standard Glucksberg grading system. |
| 1 year |
| Assess the incidence treatment-related mortality (TRM). | TRM is defined as death from non-disease related causes in the 100 days from stem cell infusion. | 1 year |
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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