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Eligible subjects will be enrolled in Celgene's long-term follow-up protocol for subjects previously treated with a CAR T-cell product.
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This study will provide long-term follow-up for patients who have received treatment with a Juno CAR T-cell product in a Juno-sponsored clinical trial. In this study, patients will be followed for up to 15 years after their last dose of Juno CAR T cells for evaluation of delayed adverse events, presence of persisting CAR T-cell vector sequences, presence of replication-competent retrovirus (RCR) or lentivirus (RCL), and survival.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JCAR017-treated | Patients who received previous treatment with JCAR017 |
| |
| JCARH125-treated | Patients who received previous treatment with JCARH125 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JCAR017 | Genetic | No drug is administered in this study. Patients who received JCAR017 in a previous trial will be evaluated in this trial for long-term safety and survival. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with adverse events | 15 years from last treatment | |
| Proportion of patients with detectable viral vector sequences | 15 years from last treatment | |
| Proportion of patients with detectable RCR or RCL | 15 years from last treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | 15 years from last treatment | |
| Progression-free survival | 15 years from last treatment |
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Inclusion Criteria:
Exclusion Criteria:
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Patients previously treated with a Juno CAR T-cell product on a Juno-sponsored clinical trial
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| Name | Affiliation | Role |
|---|---|---|
| Jacob Garcia, MD | Sponsor GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope | Duarte | California | 91010 | United States | ||
| Massachusetts General Hospital |
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Genomic DNA prepared from peripheral blood mononuclear cells
| JCARH125 | Genetic | No drug is administered in this study. Patients who received JCARH125 in a previous trial will be evaluated in this trial for long-term safety and survival. |
|
| Boston |
| Massachusetts |
| 02114 |
| United States |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D009101 | Multiple Myeloma |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D020522 | Lymphoma, Mantle-Cell |
| D008224 | Lymphoma, Follicular |
| 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 |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006474 | Hemorrhagic Disorders |
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016393 | Lymphoma, B-Cell |
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