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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
40
Assessment of long-term safety and efficacy of MB-CART19.1 treatment.
Assessment of long-term safety and efficacy of MB-CART20.1 treatment.
Assessment of long-term safety and efficacy of MB-CART2019.1 treatment.
Charité Universitätsmedizin Berlin
Berlin, Germany
RECRUITINGUniversitätsklinikum Köln
Cologne, Germany
ACTIVE_NOT_RECRUITINGUniklinikum Erlangen
Erlangen, Germany
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
Time frame: through study completion, up to 14 years
Lymphocyte count
B and T lymphocyte count
Time frame: through study completion, up to 14 years
Height
Height
Time frame: through study completion, up to 14 years
Weight
Weight
Time frame: through study completion, up to 14 years
Tanner staging for pediatric patients
Tanner staging for pediatric patients
Time frame: 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
Time frame: 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)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Universitätsmedizin Göttingen
Göttingen, Germany
ACTIVE_NOT_RECRUITINGUniversitätsklinikum Münster
Münster, Germany
RECRUITINGUniversitätsklinikum Tübingen
Tübingen, Germany
ACTIVE_NOT_RECRUITINGUniversitäts-Kinderklinik Würzburg
Würzburg, Germany
ACTIVE_NOT_RECRUITINGTime frame: through study completion, up to 14 years
Relapse / Progression
Percentage of patients who relapse or progress since enrollment and rate of surviving patients
Time frame: 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)
Time frame: through study completion, up to 14 years