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The purpose of this transgene assay testing service is to evaluate tumor samples for transgene levels in patients who received a commercially available Bristol-Myers Squibb manufactured gene modified cellular therapy and have reported a qualifying second malignancy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants treated with idecabtagene vicleucel |
| ||
| Participants treated with lisocabtagene maraleucel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Idecabtagene vicleucel | Biological | As per product label |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participant in situ hybridization (ISH) or droplet-based digital Polymerase chain reaction (ddPCR) transgene testing results | Baseline | |
| Participant insertion site analysis (ISA) testing results | For participants with positive in situ hybridization (ISH) transgene or droplet-based digital polymerase chain reaction (ddPCR) transgene | Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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Participants who receive a Bristol-Myers Squibb (BMS) manufactured Gene Modified Cell Therapy (GMCT) that have been diagnosed with a qualifying secondary malignancy
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| BMS Study Connect Contact Center www.BMSStudyConnect.com | Contact | 855-907-3286 | Clinical.Trials@bms.com | |
| First line of the email MUST contain NCT # and Site #. | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0016 | Not yet recruiting | Portland | Oregon | 97239-3098 | United States |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| FDA Safety Alerts and Recalls | View source |
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Acceptable sample types for transgene testing include:
| Lisocabtagene maraleucel | Biological | As per product label |
|
| Ut Southwestern | Recruiting | Dallas | Texas | 75235 | United States |
|
| Huntsman Cancer Institute at the University of Utah | Recruiting | Salt Lake City | Utah | 84112 | United States |
|
| Local Institution - 0004 | Withdrawn | Madison | Wisconsin | 53792 | United States |
| Universitaetsklinikum Essen (AoR) | Recruiting | Essen | 45147 | Germany |
|
| Toyokawa City Hospital | Recruiting | Toyokawa | Aichi-ken | 442-8561 | Japan |
|
| Local Institution - 0003 | Withdrawn | Kumamoto | Kumamoto | 8608556 | Japan |
| Kantonsspital Aarau | Recruiting | Aarau | 5001 | Switzerland |
|
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D015448 | Leukemia, B-Cell |
| D009101 | Multiple Myeloma |
| 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 |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
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| ID | Term |
|---|---|
| C000715380 | idecabtagene vicleucel |
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