Long-Term Follow-up of Patients Treated With Miltenyi Cell and Gene Therapies
- Conditions
- Childhood Non-Hodgkin LymphomaChronic Lymphatic LeukemiaMelanoma Stage IIIMelanoma Stage IVAcute Lymphatic LeukemiaB-cell Non Hodgkin LymphomaPediatric ALL
- Interventions
- Biological: MB-CART19.1Biological: MB-CART20.1Biological: MB-CART2019.1
- Registration Number
- NCT06508775
- Lead Sponsor
- Miltenyi Biomedicine GmbH
- Brief Summary
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- 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.
- No exclusion criteria
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Long-term follow-up of CAR T cell therapy MB-CART19.1 Assessment of long-term safety and efficacy of Miltenyi CAR T treatment. Long-term follow-up of CAR T cell therapy MB-CART20.1 Assessment of long-term safety and efficacy of Miltenyi CAR T treatment. Long-term follow-up of CAR T cell therapy MB-CART2019.1 Assessment of long-term safety and efficacy of Miltenyi CAR T treatment.
- Primary Outcome Measures
Name Time Method Adverse Events through study completion, up to 14 years 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
- Secondary Outcome Measures
Name Time Method Height through study completion, up to 14 years Height
Relapse / Progression through study completion, up to 14 years Percentage of patients who relapse or progress since enrollment and rate of surviving patients
Lymphocyte count through study completion, up to 14 years B and T lymphocyte count
Weight through study completion, up to 14 years Weight
Detectable Transgene levels through study completion, up to 14 years 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)
Tanner staging for pediatric patients through study completion, up to 14 years Tanner staging for pediatric patients
Menstruation status for pediatric patients through study completion, up to 14 years Did the patient experience their first menstrual cycle (menarche)? If yes, enter date
RCL through study completion, up to 14 years 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)
Trial Locations
- Locations (4)
Universitätsklinikum Köln
🇩🇪Cologne, Germany
Universitätsmedizin Göttingen
🇩🇪Göttingen, Germany
Universitätsklinikum Münster
🇩🇪Münster, Germany
Universitäts-Kinderklinik Würzburg
🇩🇪Würzburg, Germany