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Trial Title:
Long-Term Follow-up of Patients Treated With Miltenyi Cell and Gene Therapies
NCT ID:
NCT06508775
Condition:
Melanoma Stage III
B-cell Non Hodgkin Lymphoma
Pediatric ALL
Childhood Non-Hodgkin Lymphoma
Acute Lymphatic Leukemia
Chronic Lymphatic Leukemia
Melanoma Stage IV
Conditions: Official terms:
Lymphoma
Leukemia
Melanoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
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
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
MB-CART19.1
Description:
Assessment of long-term safety and efficacy of MB-CART19.1 treatment.
Arm group label:
Long-term follow-up of CAR T cell therapy
Other name:
CD19-targeting CAR T cells
Other name:
Anti-CD19 CAR T cells
Intervention type:
Biological
Intervention name:
MB-CART20.1
Description:
Assessment of long-term safety and efficacy of MB-CART20.1 treatment.
Arm group label:
Long-term follow-up of CAR T cell therapy
Other name:
CD20-targeting CAR T cells
Other name:
Anti-CD20 CAR T cells
Intervention type:
Biological
Intervention name:
MB-CART2019.1
Description:
Assessment of long-term safety and efficacy of MB-CART2019.1 treatment.
Arm group label:
Long-term follow-up of CAR T cell therapy
Other name:
CD20/CD19-targeting CAR T cells
Other name:
Anti-CD20/CD19 CAR T cells
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.
Criteria for 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
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Universitätsklinikum Köln
Address:
City:
Cologne
Zip:
50937
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitätsmedizin Göttingen
Address:
City:
Göttingen
Zip:
37075
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitätsklinikum Münster
Address:
City:
Münster
Zip:
48149
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitäts-Kinderklinik Würzburg
Address:
City:
Würzburg
Zip:
97080
Country:
Germany
Status:
Recruiting
Start date:
May 5, 2024
Completion date:
December 31, 2040
Lead sponsor:
Agency:
Miltenyi Biomedicine GmbH
Agency class:
Industry
Source:
Miltenyi Biomedicine GmbH
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06508775
