Long-Term Follow-up of Patients Treated With Miltenyi Cell and Gene Therapies
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Miltenyi Biomedicine GmbH
- Enrollment
- 40
- Locations
- 7
- Primary Endpoint
- Adverse Events
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts 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 exclusion criteria
Arms & Interventions
Long-term follow-up of CAR T cell therapy
Assessment of long-term safety and efficacy of Miltenyi CAR T treatment.
Intervention: MB-CART19.1 (Biological)
Long-term follow-up of CAR T cell therapy
Assessment of long-term safety and efficacy of Miltenyi CAR T treatment.
Intervention: MB-CART20.1 (Biological)
Long-term follow-up of CAR T cell therapy
Assessment of long-term safety and efficacy of Miltenyi CAR T treatment.
Intervention: MB-CART2019.1 (Biological)
Outcomes
Primary Outcomes
Adverse Events
Time Frame: 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 Outcomes
- Height(through study completion, up to 14 years)
- Relapse / Progression(through study completion, up to 14 years)
- Lymphocyte count(through study completion, up to 14 years)
- Weight(through study completion, up to 14 years)
- Detectable Transgene levels(through study completion, up to 14 years)
- Tanner staging for pediatric patients(through study completion, up to 14 years)
- Menstruation status for pediatric patients(through study completion, up to 14 years)
- RCL(through study completion, up to 14 years)