Long-Term Follow-up of Patients Treated With Miltenyi Cell and Gene Therapies
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MB-CART19.1, MB-CART20.1, MB-CART2019.1.
- Who it may be relevant to
- Registry conditions: Melanoma Stage III, B-cell Non Hodgkin Lymphoma, Pediatric ALL, Childhood Non-Hodgkin Lymphoma. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
The goal of this Long-Term Follow-Up Trial is to assess long-term safety and efficacy of Miltenyi CAR T treatment.
Detailed description
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.
Interventions
- Biological MB-CART19.1
Assessment of long-term safety and efficacy of MB-CART19.1 treatment. - Biological MB-CART20.1
Assessment of long-term safety and efficacy of MB-CART20.1 treatment. - Biological MB-CART2019.1
Assessment of long-term safety and efficacy of MB-CART2019.1 treatment.
Primary outcome measures
- Adverse Events [Time frame: through study completion, up to 14 years]
Secondary outcome measures (8)
- Lymphocyte count [Time frame: through study completion, up to 14 years]
- Height [Time frame: through study completion, up to 14 years]
- Weight [Time frame: through study completion, up to 14 years]
- Tanner staging for pediatric patients [Time frame: through study completion, up to 14 years]
- Menstruation status for pediatric patients [Time frame: through study completion, up to 14 years]
- RCL [Time frame: through study completion, up to 14 years]
- Relapse / Progression [Time frame: through study completion, up to 14 years]
- Detectable Transgene levels [Time frame: through study completion, up to 14 years]
Eligibility criteria
Inclusion criteria
- Patient underwent treatment with a Miltenyi CAR T cell therapy in one of the parent trials at least 12 months prior to enrollment in long-term follow-up.
- Patient has provided informed consent prior to enrollment.
Exclusion criteria
- No exclusion criteria
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
Germany · 7 centers
- Charité Universitätsmedizin Berlin — Berlin
- Universitätsklinikum Köln — Cologne
- Uniklinikum Erlangen — Erlangen
- Universitätsmedizin Göttingen — Göttingen
- Universitätsklinikum Münster — Münster
- Universitätsklinikum Tübingen — Tübingen
- Universitäts-Kinderklinik Würzburg — Würzburg
Identifiers
NCT: NCT06508775 · M-2022-393 · 2022-501648-14-00