Clinical trial NCT06508775: Long-Term Follow-up of Patients Treated With Miltenyi Cell and Gene Therapies
Official title: Long-Term Follow-up of Patients Treated With Miltenyi Cell and Gene Therapies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Melanoma Stage III
B-cell Non Hodgkin Lymphoma
Pediatric ALL
Childhood Non-Hodgkin Lymphoma
Acute Lymphatic Leukemia
Chronic Lymphatic Leukemia
Melanoma Stage IV
Lead sponsor: Miltenyi Biomedicine GmbH
Sponsor class: INDUSTRY
First posted: 2024-07-18
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Adverse Events
timeFrame: through study completion, up to 14 years
Secondary outcomes:
measure: Lymphocyte count
timeFrame: through study completion, up to 14 years
measure: Height
timeFrame: through study completion, up to 14 years
measure: Weight
timeFrame: through study completion, up to 14 years
measure: Tanner staging for pediatric patients
timeFrame: through study completion, up to 14 years
measure: Menstruation status for pediatric patients
timeFrame: through study completion, up to 14 years
measure: RCL
timeFrame: through study completion, up to 14 years
measure: Relapse / Progression
timeFrame: through study completion, up to 14 years
measure: Detectable Transgene levels
timeFrame: through study completion, up to 14 years
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: Universitätsklinikum Köln
city: Göttingen
country: Germany
facility: Universitätsmedizin Göttingen
city: Münster
country: Germany
facility: Universitätsklinikum Münster
city: Würzburg
country: Germany
facility: Universitäts-Kinderklinik Würzburg
Study officials:
affiliation: Universitätsklinikum Münster
name: Claudia Rössig, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: