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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2014-01609 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| IRB-30861 | Other Identifier | Stanford IRB | |
| BMT267 | Other Identifier | OnCore |
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Logistics
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This phase I trial studies the side effects and best dose of donor regulatory T cells in treating patients with graft-versus-host disease affecting the liver or gastrointestinal organs (visceral) within 100 days (acute) after undergoing a stem cell transplant. Graft-versus-host disease occurs when donor immune cells infused in a stem cell transplant attack the gut, skin, liver, or other organ systems of the patient. Regulatory T cells are a type of immune cell that may be able to reduce the attack of the donor's immune cells on the patient's normal cells and help treat graft-vs-host disease.
PRIMARY OBJECTIVES:
I. Determine the safety and feasibility of donor T regulatory (Treg) cell infusions in subjects with visceral acute graft-versus-host disease (aGVHD) and incidence of dose limiting toxicities (DLTs) graded according to the Common Terminology Criteria for Adverse Events (CTCAE version 4 [v.4]) with a focus on infusion reactions within 24 hours, respiratory distress within 72 hours of infusion and all-cause mortality within 28 days of infusion.
SECONDARY OBJECTIVES:
I. Determine the quantitative blood Treg cell changes following the cell infusions.
II. Assess dosing requirements and treatment response rates to primary steroid, secondary and tertiary immunosuppressive therapy.
III. Post-transplant day +100 and day +180 survival. IV. Post-transplant incidence of chronic graft-versus-host disease (GVHD) at day +180.
OUTLINE: This is a dose-escalation study.
Patients receive donor regulatory T lymphocytes intravenously (IV) over 5 minutes or less on day 0. Some patients receive a second infusion of frozen donor regulatory T lymphocytes 5-7 days after the initial infusion or 2 additional infusions separated by 5-7 days.
After completion of study treatment, patients are followed up weekly until day 28 and then on days 100 and 180.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (donor regulatory T lymphocytes) | Experimental | Patients receive donor regulatory T lymphocytes intravenously (IV) over 5 minutes or less on day 0. Some patients receive a second infusion of frozen donor regulatory T lymphocytes 5-7 days after the initial infusion or 2 additional infusions separated by 5-7 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| donor regulatory T lymphocytes | Biological | Given IV |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of grade 3 infusion reaction within 24 hours of infusion | Dose-limiting toxicity will be defined as CTCAE Grade 3 or higher cytokine/release syndrome/acute infusion reaction within 24 hours after Treg cell infusion. The rates of defined DLTs will be calculated and the one-sided upper 80%, 90%, and 95% confidence limits calculated. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of grade 3 or higher non-GVHD infusion-related adverse events | Incidence of grade 3 or higher non-GVHD infusion-related adverse events according to the CTCAE v4 that are not anticipated following HCT will be reported | Up to day 28 |
| Grade 4 (life threatening) or 5 (fatal) adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Everett Meyer | Stanford University Hospitals and Clinics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University Hospitals and Clinics | Stanford | California | 94305 | United States |
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| ID | Term |
|---|---|
| D006086 | Graft vs Host Disease |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| laboratory biomarker analysis | Other | Correlative studies |
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Grade 4 (life threatening) or 5 (fatal) adverse events within after 28 days of Treg infusion that were otherwise unexpected in the immediate post transplant setting will be reported |
| 28 days |
| Grade 4 (life threatening) respiratory distress | Grade 4 (life threatening) respiratory distress within 72 hours of Treg infusion will be reported | 72 hours |
| Change in blood Treg cell numbers following the infusions | The change in Treg cell counts from baseline to post infusion will be depicted in boxplots of both relative proportion and absolute numbers. Mean log (fold change) and confidence intervals will be calculated. The confidence intervals will be used to test the hypotheses of no change from baseline to post infusion. | Baseline to up to day 28 |
| Overall survival (OS) | The OS will be estimated by the Kaplan-Meier product-limit method, with standard confidence limits. | Day 100 |
| Incidence of cGVHD. | Incidence of cGVHD will be reported at Post HCT day +180 | 180 days |