Lentiviral Gene Therapy (Zamtocabtagene Autoleucel) LTFU
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Long-term Follow-Up.
- Who it may be relevant to
- Registry conditions: Non Hodgkin Lymphoma, Refractory Diffuse Large B Cell Lymphoma (DLBCL), Relapsed Diffuse Large B Cell Lymphoma, High Grade B-cell Lymphoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Prospective, Observational, Long-term Follow-up Study for Subjects Who Previously Received Zamtocabtagene Autoleucel in a North American Miltenyi Biomedicine-Sponsored Clinical Study
Overview
This is an observational long-term follow-up (LTFU) study for subjects who previously received zamtocabtagene autoleucel, known as MB-CART2019.1.
Detailed description
This is a non-therapeutic study design. After successful screening, subjects will be monitored for potential gene therapy-related adverse events for up to 15 years post MB-CART2019.1 infusion. Subjects will be assessed yearly for the occurrence of delayed adverse events (AEs), monitored for replication competent lentivirus (RCL) and assessed for long term efficacy as well as CAR-T persistence.
Interventions
- Other Long-term Follow-Up
No intervention
Primary outcome measures
- Number of subjects with new or recurrence of pre-existing malignancy [Time frame: Up to 15 years]
- Number of subjects with new incidence or exacerbation of a pre-existing neurological disorder [Time frame: Up to 15 years]
- Number of subjects with new incidence or exacerbation of pre-existing rheumatologic or other autoimmune disorders [Time frame: Up to 15 years]
- Number of subjects with new incidence of Grade ≥ 3 hematologic disorders [Time frame: Up to 15 years]
- Number of subjects with related AEs, related SAEs, and all AESIs [Time frame: Up to 15 years]
Secondary outcome measures (6)
- Number of subjects with measurable replication competent lentivirus in peripheral blood (if positive at study entry) [Time frame: Up to 15 years]
- Duration of zamtocabtagene autoleucel persistence [Time frame: Up to 15 years]
- Objective Response Rate (ORR) [Time frame: Up to 15 years]
- Overall Survival [Time frame: Up to 15 years]
- To determine the number of subjects who relapse after zamtocabtagene autoleucel infusion during LTFU [Time frame: Up to 15 years]
- To assess immune reconstitution based on the recovery of total lymphocytes [Time frame: Up to 15 years]
Eligibility criteria
Inclusion criteria
- Received zamtocabtagene autoleucel in a North American Miltenyi Biomedicine-sponsored clinical study and have not withdrawn consent to be followed or been deemed lost to follow-up.
- Provided written informed consent to participate in this study.
Exclusion criteria
- None
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 11 centers
- Banner MD Anderson Cancer Center — Gilbert
- Stanford University — Stanford
- Yale University — New Haven
- Robert H Lurie Cancer Center — Chicago
- University of Kansas Cancer Center — Westwood
- University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center — Baltimore
- Dana Farber Cancer Institute — Boston
- Duke University Medical Center - Division of Hematologic Malignancies — Durham
- … and 3 more centers
Identifiers
NCT: NCT06116110 · M-2023-401