Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Children's Hospital of Philadelphia | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stratum 1 | Experimental | Patients receiving an unrelated donor or partially matched related donor. |
|
| Stratum 2 | Experimental | For the patient's whose donors are haploidentical or a 2 antigen mismatched where one of the mismatches includes DRB1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CliniMACS (CD+3, CD+19 depletion) | Device | Patient's in Stratum 1 will receive grafts that have undergone CD3+, CD19+ depletion |
|
| Measure | Description | Time Frame |
|---|---|---|
| To measure the incidence and quality of engraftment | Weekly for first 100 days, 6 months and 1 year |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Julie A 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| CliniMACS (CD 34+ positive selection) | Device | Patient's in Stratum 2 will receive peripheral blood progenitor cells that have undergone CD34+ selection |
|
| HSCT | Other | Peripheral Blood Stem Cell Transplant |
|
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D008223 | Lymphoma |
| D000080983 | Bone Marrow Failure Disorders |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D001855 | Bone Marrow Diseases |
Not provided
Not provided