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| ID | Type | Description | Link |
|---|---|---|---|
| 858761 | Other Identifier | University of Pennsylvania Institutional Review Board |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This clinical trial assesses whether it is feasible to use radiation therapy with vancomycin prior to CAR T-cell therapy for patients with large B-cell lymphomas
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vancomycin, radiation therapy, and CAR-T | Experimental | vancomycin 125 mg orally four times per day, followed by standard of care radiation and standard of care CD19 CAR T-cells |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vancomycin 125mg | Drug | oral |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cytokine release syndrome | rate of CART-related cytokine release syndrome | date of CAR-T infusion to 28 days after infusion |
| Severe adverse events | rate of grade ≥ 3 adverse events attributed to vancomycin or radiation | CAR-T infusion to 28 days after infusion |
| VRE | rate of vancomycin-related enterococcus | start of vancomycin to day 28 after CAR-T infusion |
| Adverse Events | rate of adverse events (AEs) and serious adverse events (SAEs) | start of vancomycin until day 28 after CAR-T infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Best overall response rate | percentage of all patients who receive CAR-T and have complete response and partial response after CAR-T | CAR-T infusion to 12 months after CAR-T infusion |
| Complete response rate |
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Inclusion Criteria:
The following age-specific requirements apply:
Women < 50 years of age: amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution; or Underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
Women ≥ 50 years of age: amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or had radiation-induced menopause with last menses >1 year ago; or had chemotherapy-induced menopause with last menses >1 year ago; or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy).
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rachel Lundberg, PA-C | Contact | 215-615-5858 | rachel.lundberg@pennmedicine.upenn.edu | |
| Megan Jones, MPH | Contact | megan.jones1@pennmedicine.upenn.edu |
| Name | Affiliation | Role |
|---|---|---|
| Elise Chong, MD | Abramson Cancer Center, University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abramson Cancer Center, University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| Radiation Therapy |
| Radiation |
Radiation Therapy |
|
| CAR-T | Biological | standard of care anti-CD19 CAR-T |
|
percentage of patients treated with CAR-T who have a complete response
| CAR-T infusion to 12 months after CAR-T infusion |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D016393 | Lymphoma, B-Cell |
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| ID | Term |
|---|---|
| D014640 | Vancomycin |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D013812 | Therapeutics |
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