CAR-Multicenter Analysis (CAR-MA): Retrospective Study to Characterize CAR T-cell Outcomes and Related Toxicities in Children and Young Adults With B-ALL
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About
Study Description:
This retrospective protocol focuses on characterizing clinical outcomes and toxicities following CAR T-cell therapy.
Objectives:
Primary
To evaluate the Response Free Survival (RFS) at 6 months following CD19 CAR stratified by prior blinatumomab vs no prior blinatumomab. Completed
To retrospectively evaluate outcomes following CAR T-cell therapy across children and young adults with B-ALL
Secondary
To evaluate the RFS at 12 months following CD19 CAR stratified by prior blinatumomab vs no prior blinatumomab and other immunotherapy. Completed
To evaluate the incidence of CD19 negative versus CD19 positive relapse following CD19 CAR stratified by prior blinatumomab vs no prior blinatumomab. Completed
To evaluate the Complete Response (CR) rate following CD19 CAR stratified by prior blinatumomab vs no prior blinatumomab. Completed
To evaluate the Minimal Residual Disease (MRD) negative remission rate following CD19 CAR stratified by prior blinatumomab vs no prior blinatumomab. Completed
To evaluate the impact of prior blinatumomab, prior inotuzumab, and other immunotherapies on subsequent CAR T cell outcomes.
To determine the incidence, severity, resolution and risk factors for early and late cytopenias after CAR T-cell therapy.
To evaluate the response of extramedullary disease following CAR T-cell therapy.
To evaluate the frequency of subsequent malignant neoplasms after CAR T-cell therapy.
To describe response, survival, and toxicities after CAR T-cell therapy in children with trisomy 21 and other important subpopulations.
To determine the impact of next-generation sequencing MRD results and duration of B-cell aplasia on CAR T cell outcomes.
To evaluate the frequency of infections and describe immune system function after CAR T-cell therapy.
To describe response, survival, and toxicities after CAR T-cell therapy in children with leukemia containing specific cytogenetic lesions (e.gl. TP53, t(1;19), hypodiploidy).
To compare toxicities and outcomes across CAR T-cell constructs (e.g., different CD19 CAR constructs, dual-targeted CARs, CD22-targeted CARs, etc.).
To assess the impact of CAR T cells on other health-related outcomes, including, but not limited to, organ function, immune reconstitution, quality of life, and patient-reported outcomes.
Study Population and Source of Data: Subjects who were less than < 25 years of age at the time of diagnosis and received a CAR T-cell product for B-ALL.
Full description
Study Description:
This retrospective protocol focuses on characterizing clinical outcomes and toxicities following CAR T-cell therapy.
Objectives:
Primary
- To evaluate the Response Free Survival (RFS) at 6 months following CD19 CAR stratified by prior blinatumomab vs no prior blinatumomab. COMPLETED.
- To retrospectively evaluate outcomes following CAR T-cell therapy across children and young adults with B-ALL
Secondary
- To evaluate the RFS at 12 months following CD19 CAR stratified by prior blinatumomab vs no prior blinatumomab and other immunotherapy. COMPLETED.
- To evaluate the incidence of CD19 negative versus CD19 positive relapse following CD19 CAR stratified by prior blinatumomab vs no prior blinatumomab. COMPLETED.
- To evaluate the Complete Response (CR) rate following CD19 CAR stratified by prior blinatumomab vs no prior blinatumomab. COMPLETED.
- To evaluate the Minimal Residual Disease (MRD) negative remission rate following CD19 CAR stratified by prior blinatumomab vs no prior blinatumomab. COMPLETED.
- To evaluate the impact of prior blinatumomab, prior inotuzumab, and other immunotherapies on subsequent CAR T cell outcomes.
- To determine the incidence, severity, resolution and risk factors for early and late cytopenias after CAR T-cell therapy.
- To evaluate the response of extramedullary disease following CAR T-cell therapy.
- To evaluate the frequency of subsequent malignant neoplasms after CAR T-cell therapy.
- To describe response, survival, and toxicities after CAR Tcell therapy in children with trisomy 21 and other important subpopulations.
- To determine the impact of next-generation sequencing MRD results and duration of B-cell aplasia on CAR T cell outcomes.
- To evaluate the frequency of infections and describe immune system function after CAR T-cell therapy.
- To describe response, survival, and toxicities after CAR Tcell therapy in children with leukemia containing specific cytogenetic lesions (e.gl. TP53, t(1;19), hypodiploidy).
- To compare toxicities and outcomes across CAR T-cell constructs (e.g., different CD19 CAR constructs, dual-targeted CARs, CD22-targeted CARs, etc.).
- To assess the impact of CAR T cells on other health-related outcomes, including, but not limited to, organ function, immune reconstitution, quality of life, and patient-reported outcomes.
Enrollment
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Volunteers
Inclusion and exclusion criteria
- Subjects will not be recruited for this study; however, up to 210 subjects records will be selected from treatment protocols who received CAR therapy for B-ALL. Subject who opted out of the future use of his/her data will be excluded. The subjects enrolled to a CAR T cell therapy treatment protocol within the Pediatric Oncology Branch unless, are < 25 years of age at the time of diagnosis and must have received prior a CAR T-cell product.
Trial design
57 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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