Melanoma Stage III, B-cell Non Hodgkin Lymphoma, Pediatric ALL, Childhood Non-Hodgkin Lymphoma, Acute Lymphatic Leukemia, Chronic Lymphatic Leukemia, Melanoma Stage IV
Conditions
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.
Interventions
BIOLOGICALMB-CART19.1
Assessment of long-term safety and efficacy of MB-CART19.1 treatment.
BIOLOGICALMB-CART20.1
Assessment of long-term safety and efficacy of MB-CART20.1 treatment.
BIOLOGICALMB-CART2019.1
Assessment of long-term safety and efficacy of MB-CART2019.1 treatment.
Sponsors
Miltenyi Biomedicine GmbH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
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
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Height | through study completion, up to 14 years | Height |
| Weight | through study completion, up to 14 years | Weight |
| Tanner staging for pediatric patients | through study completion, up to 14 years | Tanner staging for pediatric patients |
| Lymphocyte count | through study completion, up to 14 years | B and T lymphocyte count |
| 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) |
| Relapse / Progression | through study completion, up to 14 years | Percentage of patients who relapse or progress since enrollment and rate of surviving patients |
| 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) |
| 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 |
Countries
Germany
Contacts
Primary ContactClinical Trial Manager
Outcome results
None listed