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This study will provide long-term follow-up for patients who have received treatment with JCAR015 in a previous clinical trial. In this study, patients will be followed for up to 15 years after their last dose of JCAR015 for evaluation of delayed adverse events, presence of persisting JCAR015 vector sequences, and survival.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JCAR015-treated | Patients who received previous treatment with JCAR015 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JCAR015 | Genetic | No study drug is administered in this study. Patients who received JCAR015 in a previous trial will be evaluated in this trial for long-term safety and efficacy. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with adverse events | Every year for up to 15 years post-treatment | |
| Proportion of patients with detectable JCAR015 vector sequences during first 5 years post-treatment | Every 6 months for the first 5 years post-treatment | |
| Proportion of patients with detectable JCAR015 vector sequences between 5 and 15 years post-treatment | Every year from 5 years post-treatment to up to 15 years post-treatment | |
| Survival | Up to 15 years |
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Inclusion criteria:
Exclusion criteria:
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Patients previously treated with JCAR015 in a prior clinical trial
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States | ||
| Johns Hopkins Sidney Kimmel Comprehensive Cancer Center |
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| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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Genomic DNA prepared from peripheral blood mononuclear cells
| Baltimore |
| Maryland |
| 21231 |
| United States |
| Washington University School of Medicine | St Louis | Missouri | 63110-1093 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |