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| Name | Class |
|---|---|
| City of Hope Medical Center | OTHER |
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This is a single-center, open-label, single-arm, pilot clinical study using TCRα/β and CD45RA depleted stem cell grafts from haploidentical donors for hematopoietic cell transplantation in 12 to 18 adult patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HSC Recipient | Experimental | PBSC grafts from haploidentical donors depleted of TCRaβ+ cells and CD45RA+ cells using CliniMACS Prodigy® will be infused into patients intravenously (IV) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CliniMACS Prodigy® LP-TCRα/β-19-45RA (Trial Version) | Device | PBSC grafts from haploidentical donors depleted of TCRaβ+ cells and CD45RA+ cells using CliniMACS Prodigy® will be infused into patients intravenously (IV) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of severe acute GVHD (aGVHD) till Day 100 | Participants will be evaluated for the occurrence of aGVHD, grades III-IV in the first 100 days after transplantation and the time to occurrence of aGVHD, grades III-IV will be recorded. Severity of acute GVHD will be graded according to the CONSENSUS CRITERIA FOR GRADING OF ACUTE GVHD which has four Grades from Grade I to Grade IV. The higher the Score, the Worse the outcome. | 100 days after haploidentical hematopoietic cell transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| Performance of the CliniMACS Prodigy® LP-TCRα/β-19-45RA(Trial Version) | Performance of the CliniMACS Prodigy® LP-TCRα/β-19-45RA (Trial Version) will be assessed by calculating the log-depletion of TCRα/β+ and CD45RA+ cells | Until Last Patient Last Visit(24 Months) |
| Incidence of acute GVHD (aGVHD) till six months post-transplantation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Premchand Pastula | Contact | +49 15144059503 | clinicaltrials_gov_ClinDev@miltenyibiotec.de |
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| Label | URL |
|---|---|
| A multi-center phase I/II safety and feasibility study using CliniMACS TCRα/β and CD19 depleted stem cell grafts from haploidentical donors for hematopoietic progenitor cell transplantation in children and adults" | View source |
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| 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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Incidence of aGVHD, grade II-IV till six months post-transplantation will be evaluated. The maximum grade and the time to occurrence of acute GVHD will be recorded. Incidence and severity of acute GVHD will be graded according to the Consensus Criteria |
| 6 Months |
| Neutrophil Engraftment | Time to neutrophil engraftment will be defined as the first of three consecutive measurements of ANC ≥500/µL following conditioning regimen induced nadir, starting from the day of the first stem cell transplantation | Day 7 |
| Platelet Engraftment | Time to platelet engraftment will be defined as the first of three consecutive measurements of platelet count ≥20,000/µL without platelet transfusion support, starting from the day of the first stem cell transplantation. | Day 0 |
| Chronic GVHD | Incidence and severity of chronic GVHD will be graded according to standard criteria for grading of chronic GVHD | 1 Year |
| Non-relapse mortality (NRM) | NRM is defined as death occurring in a patient between the first day of conditioning and day of last assessment (all visits throughout the study), not due to disease relapse/recurrence | Until Last patient last Visit(24 Months) |
| Infusion toxicity | Maximum infusion toxicity on the days of transfusion will be evaluated by measuring the patient's blood pressure, heart rate, respiration rate and temperature one hour prior to the allograft infusion and then approximately 15 minutes, 30 minutes, 2 hours, and 4 hours post infusion | 15 minutes, 30 minutes, 2 hours, and 4 hours post infusion |
| Graft failure | Primary graft failure is defined as the failure to achieve an ANC ≥500 cells/µL by Day +30 in the setting of donor chimerism < 5% using local methods | 30 Days |
| Overall survival (OS) | OS defined as time from transplantation to death or last follow-up and will be assessed at Day 100 and after 1 year | Day 100 and through study completion, an average of 1 year post transplantation |
| Disease-free survival (DFS) | DFS is defined as the minimum time to relapse/recurrence, to death or to the last follow-up, from the time of transplantation and will be assessed at Day 100 and after 1 year | Day 100 and through study completion, an average of 1 year post transplantation |
| GVHD/relapse-free survival (GRFS) | An event is defined as grade III-IV acute GVHD, moderate to severe chronic GVHD, disease relapse, or death by any cause. GRFS will be assessed at 1 year. | GRFS will be assessed at Month 12 post transplantation |
| Immunosuppression-free survival (ISFS) | Defined as being alive, relapse-free and off immunosuppressive therapy and will be assessed at 1 year with a starting point at Day 45 post-transplantation. Immune suppression is defined as any systemic agents used to control or suppress GVHD. | Assessed at 1 year with a starting point at Day 45 post-transplantation |
| Relapse rate | Time to relapse will be calculated from the time of transplantation to evidence of relapse | 12 Months |
| Hospitalization length/re-admission | Number of days that patients had to be hospitalized until discharge after transplantation, and after any subsequent occurrence of an event leading to re- hospitalization assessed | Assessed at Day 30, Day 100 and at 12 Months post transplantation |