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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-501648-14-00 | EU Trial (CTIS) Number |
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The goal of this Long-Term Follow-Up Trial is to assess long-term safety and efficacy of Miltenyi CAR T treatment.
The focus in this trial is on the occurrence of any late adverse reactions (AR), serious adverse events (SAE), serious adverse reactions (SAR) and adverse events of special interest (AESI), i.e. relapse or progression of the underlying disease, life-threatening infections, death due to any case, new and secondary malignancies, lymphocyte counts, detection of the transgene of the CAR T cells, detection of replication-competent lentivirus (RCL), developmental tracking in pediatric patients and furthermore, assessment of the primary status of disease progression and overall survival.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Long-term follow-up of CAR T cell therapy | Experimental | Assessment of long-term safety and efficacy of Miltenyi CAR T treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MB-CART19.1 | Biological | Assessment of long-term safety and efficacy of MB-CART19.1 treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Percentage of patients with late-onset adverse reactions (AR), serious adverse events (SAE), serious adverse reactions (SAR) and adverse events of special interest (AESI) including relapse or progression of the underlying disease, life-threatening infections, death due to any cause, new and secondary malignancies | through study completion, up to 14 years |
| Measure | Description | Time Frame |
|---|---|---|
| Lymphocyte count | B and T lymphocyte count | through study completion, up to 14 years |
| Height | Height | through study completion, up to 14 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Manager | Contact | +4922048306820 | clinicaltrials.gov@miltenyi.com |
| Name | Affiliation | Role |
|---|---|---|
| Claudia Rössig, Prof. Dr. | Universitätsklinikum Münster | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité Universitätsmedizin Berlin | Recruiting | Berlin | 13353 | Germany | ||
| Universitätsklinikum Köln |
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Single dose treatment with CAR T cell therapy in previous trial, long-term follow-up in this trial with cohorts: MB-CART20.1 Lymphoma, MB-CART20.1 Melanoma, MB-CART19.1 pediatric ALL and progressive NHL, MB-CART19.1 adult ALL, MB-CART19.1 adult NHL/CLL, MB-CART2019.1 Lymphoma
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| MB-CART20.1 | Biological | Assessment of long-term safety and efficacy of MB-CART20.1 treatment. |
|
|
| MB-CART2019.1 | Biological | Assessment of long-term safety and efficacy of MB-CART2019.1 treatment. |
|
|
| Weight | Weight | through study completion, up to 14 years |
| Tanner staging for pediatric patients | Tanner staging for pediatric patients | through study completion, up to 14 years |
| Menstruation status for pediatric patients | Did the patient experience their first menstrual cycle (menarche)? If yes, enter date | through study completion, up to 14 years |
| RCL | Percentage of patients with detectable replication-competent lentivirus (RCL) (if results of 2 consecutive years are negative for an individual patient, further sampling will not be continued for this patient; if results of all samples in first year of primary trial were negative for an individual patient, sampling will not be continued for this patient in this long-term follow-up trial) | through study completion, up to 14 years |
| Relapse / Progression | Percentage of patients who relapse or progress since enrollment and rate of surviving patients | through study completion, up to 14 years |
| Detectable Transgene levels | Percentage of patients with detectable transgene levels (if results of 2 consecutive years are negative for an individual patient, further sampling will be stopped for this patient) | through study completion, up to 14 years |
| Active, not recruiting |
| Cologne |
| 50937 |
| Germany |
| Uniklinikum Erlangen | Active, not recruiting | Erlangen | 91054 | Germany |
| Universitätsmedizin Göttingen | Active, not recruiting | Göttingen | 37075 | Germany |
| Universitätsklinikum Münster | Recruiting | Münster | 48149 | Germany |
| Universitätsklinikum Tübingen | Active, not recruiting | Tübingen | 72076 | Germany |
| Universitäts-Kinderklinik Würzburg | Active, not recruiting | Würzburg | 97080 | Germany |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| D016393 | Lymphoma, B-Cell |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| 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 |
| D015448 | Leukemia, B-Cell |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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