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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-000297-38 | EudraCT Number |
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| Name | Class |
|---|---|
| ADIR, a Servier Group company | INDUSTRY |
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The purpose of this study is to evaluate the long-term safety and efficacy of UCART19 administration to patients with advanced lymphoid leukemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UCART19 follow-up | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UCART19 follow-up | Biological | UCART19 will not be administered during the study period. Patients who will be rolled-over from the parent study to this long term follow-up study, have previously received UCART19. The roll-over occurs at the end of the parent study, or at any time after UCART19 administration, in case of premature discontinuation from the parent study. |
| Measure | Description | Time Frame |
|---|---|---|
| Long-term safety of UCART19 with or without alemtuzumab |
| Up to 15 Year |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of long-term anti tumor activity of UCART19 | Month 3, Month 6, Month 12 during Year 1 following last UCART19 dosing then every 6 months up to Year 3, then yearly up to Year 15 | |
| Proportion of patients who underwent allogeneic HSCT (Hematopoietic Stem Cell Transplantation) for patients treated with UCART19 |
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Inclusion Criteria:
Exclusion Criteria:
- No exclusion criteria for this study
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| Name | Affiliation | Role |
|---|---|---|
| Reuben Benjamin, MD, PhD | King's College Hospital NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | United States | ||
| Colorado Blood Cancer Institute |
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| Label | URL |
|---|---|
| Find Results on Servier Clinical Trial Data | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| Individual Participant Data Set | View IPD |
Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.
Access can be requested for all interventional clinical studies:
In addition, access can be requested for all interventional clinical studies in patients:
After Marketing Authorisation in EEA or US if the study is used for the approval.
Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.
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| Month 3, Month 6, Month 12 during Year 1 following last UCART19 dosing, then every 6 months up to Year 3, then yearly up to Year 15 |
| Time to transplant for patients treated with UCART19 | Month 3, Month 6, Month 12 during Year 1 following last UCART19 dosing, then every 6 months up to Year 3, then yearly up to Year 15 |
| Assessment of overall survival | Month 3, Month 6, Month 12 during Year 1 following last UCART19 dosing, then every 6 months up to Year 3, then yearly up to Year 15 |
| Proportion of patients with detectable UCART19 levels in blood | Month 3, Month 6, Month 12 during Year 1 following last UCART19 dosing (If no more UCART19 detectable at the Month 12 visit), then every 6 months up to Year 3, then yearly up to Year 15 or the first evidence of no more detectable UCART19 (if earlier) |
| Proportion of patients with detectable UCART19 levels in bone marrow | Month 3, Month 6, Month 12 during Year 1 following last UCART19 dosing, then every 6 months up to Year 3, then yearly up to Year 15 |
| Denver |
| Colorado |
| 80219 |
| United States |
| Moffit Cancer Center | Tampa | Florida | 33612 | United States |
| Massachussetts General Hospital | Charlestown | Massachusetts | 02129 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75235 | United States |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Hôpital Saint-Louis | Paris | 75010 | France |
| Hôpital Robert-Debré | Paris | 75019 | France |
| Hôpital Saint-Antoine | Paris | 75571 | France |
| Kyushyu University Hospital | Fukuoka | 812-8582 | Japan |
| Hokkaido University Hospital | Sapporo | 060-8648 | Japan |
| Hospital San Juan De Dios | Barcelona | 08950 | Spain |
| King's College Hospital NHS Foundation Trust | London | SE5 9RS | United Kingdom |
| UCL Great Ormond Hospital | London | United Kingdom |
| The Christie NHS Foundation Trust | Manchester | M20 4BX | United Kingdom |
| Study Protocol | View IPD |
| Statistical Analysis Plan | View IPD |
| Informed Consent Form | View IPD |
| Clinical Study Report | View IPD |
| Study-level clinical trial data | View IPD |