Unresectable stage III or IV melanoma, Relapsed or refractory B cell non-Hodgkins lymphoma (NHL), Relapsed or refractory CD20 positive B-cell non-Hodgkin’s lymphoma (NHL), Relapsed or refractory CD19 positive B cell malignancies (pediatric acute lymphatic leukemia [ALL], aggressive NHL), Relapsed or refractory CD19 positive B cell malignancies (adult ALL, adult NHL/chronic lymphatic leukemia [CLL])
Conditions
Brief summary
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
Detailed description
B- and T-lymphocyte count, Height and weight, Tanner staging, menstruation status for pediatric patients, 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), Percentage of patients who relapse or progress since enrollment and rate of surviving patients, 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)
Interventions
Sponsors
Miltenyi Biomedicine GmbH
Eligibility
Sex/Gender
All
Age
0 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| B- and T-lymphocyte count, Height and weight, Tanner staging, menstruation status for pediatric patients, 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), Percentage of patients who relapse or progress since enrollment and rate of surviving patients, 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) | — |
Countries
Germany
Outcome results
None listed