Long-Term Follow-up of Patients Treated With Miltenyi Cell and Gene Therapies (LONGSAFE)

Miltenyi Biotec

Status

Enrolling

Conditions

Melanoma Stage IV

Melanoma Stage III

Chronic Lymphatic Leukemia

B-cell Non Hodgkin Lymphoma

Pediatric ALL

Childhood Non-Hodgkin Lymphoma

Acute Lymphatic Leukemia

Treatments

Biological: MB-CART19.1

Biological: MB-CART2019.1

Biological: MB-CART20.1

Study type

Interventional

Funder types

Industry

Identifiers

NCT06508775

M-2022-393

2022-501648-14-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

The goal of this Long-Term Follow-Up Trial is to assess long-term safety and efficacy of Miltenyi CAR T treatment.

Full 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.

Enrollment

40 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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