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| ID | Type | Description | Link |
|---|---|---|---|
| BT13BTθ51 | Other Identifier | The Children's Hospital of Philadelphia |
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This is a single arm pilot study for patients using α/β T cell-depleted peripheral Stem Cell Transplantation (PSCT) in with alternative donor sources with hematologic malignancies receiving alternative donor (unrelated or partially matched related) mobilized peripheral stem cells (PSCs) using the CliniMACS system for T cell depletion plus CD19+ B cell depletion to determine efficacy as determined by engraftment and graft versus host disease (GVHD), and one year leukemia free survival.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alpha Beta Total Body Irradiation - total body irradiation (TBI) first | Experimental | Alpha Beta Total Body Irradiation - TBI first Day Treatment
| |
| Alpha Beta Total Body Irradiation - TBI last | Experimental | Alpha Beta Total Body Irradiation - TBI last Day Treatment
| |
| Alpha Beta Non-irradiation regimen | Experimental | Alpha Beta Non-irradiation regimen Day Treatment
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alpha Beta T cell depletion | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Engraftment: rates of engraftment, defined as the first day of Absolute Neutrophil Count (ANC) greater than 500 for the first of three consecutive days | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Severe acute and chronic graft versus host disease (GVHD) | Estimation of the incidence and extent of acute and chronic GVHD. The overall incidence of acute GVHD, the incidence of Grade 4 acute GVHD and the incidence of chronic GVHD. | 1 year |
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Inclusion Criteria:
Leukemias/lymphomas
Acceptable organ status clearance
No active untreated infection. Patients with possible fungal infections must have had at least 2 weeks of appropriate anti-fungal antibiotics and be asymptomatic
Signed informed consent.
Negative pregnancy test for females of childbearing potential.
Exclusion Criteria:
Donor must be either unrelated, mismatched up to one antigen/one antigen and one allele or a related, HLA match other than a sibling.
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| Name | Affiliation | Role |
|---|---|---|
| Timothy Olson, MD, PhD | Children's Hospital of Philadelphia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19103 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34872106 | Derived | Leahy AB, Li Y, Talano JA, Elgarten CW, Seif AE, Wang Y, Johnson B, Monos DS, Kadauke S, Olson TS, Freedman J, Wray L, Grupp SA, Bunin N. Unrelated donor alpha/beta T cell- and B cell-depleted HSCT for the treatment of pediatric acute leukemia. Blood Adv. 2022 Feb 22;6(4):1175-1185. doi: 10.1182/bloodadvances.2021005492. |
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| ID | Term |
|---|---|
| D007938 | Leukemia |
| D008223 | Lymphoma |
| D000754 | Anemia, Refractory, with Excess of Blasts |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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intervention with device: Alpha Beta T cell depletion
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| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D000753 | Anemia, Refractory |
| D000740 | Anemia |
| D009190 | Myelodysplastic Syndromes |
| D001855 | Bone Marrow Diseases |