Clinical trial NCT05440409: CAR-Multicenter Analysis (CAR-MA): Retrospective Study to Characterize CAR T-cell Outcomes and Related Toxicities in Children and Young Adults With B-ALL
Official title: CAR-Multicenter Analysis (CAR-MA): Retrospective Study to Characterize CAR T-cell Outcomes and Related Toxicities in Children and Young Adults With B-ALL
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia, Acute Lymphoblastic
Lymphoblastic Leukemia, Acute, Childhood
Keywords: Relapsed Disease
MRD-positive CD19+ ALL
Natural History
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2022-06-30
Enrollment: 57
Sex: ALL
Minimum age (years): 3
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects who were \< = 25 years of age at the time of diagnosis and received a CAR T-cell product for B-ALL. This protocol will be amended to incorporate new research objectives and new data as necessary

Brief summary: 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

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.

To evaluate the incidence of CD19 negative versus CD19 positive relapse following CD19 CAR stratified by prior blinatumomab vs no prior blinatumomab.

To evaluate the Complete Response (CR) rate following CD19 CAR stratified by prior blinatumomab vs no prior blinatumomab.

To evaluate the Minimal Residual Disease (MRD) negative remission rate following CD19 CAR stratified by prior blinatumomab vs no prior blinatumomab.

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.

Detailed 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

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.

To evaluate the incidence of CD19 negative versus CD19 positive relapse following CD19 CAR stratified by prior blinatumomab vs no prior blinatumomab.

To evaluate the Complete Response (CR) rate following CD19 CAR stratified by prior blinatumomab vs no prior blinatumomab.

To evaluate the Minimal Residual Disease (MRD) negative remission rate following CD19 CAR stratified by prior blinatumomab vs no prior blinatumomab.

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.

Eligibility 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.

Primary outcomes:
measure: Outcome evaluation
timeFrame: 12 months
measure: Response free survival
timeFrame: 6 months
Secondary outcomes:
measure: Minimal Residual Disease detection
timeFrame: 12 months
measure: Response free survival
timeFrame: 12 months
measure: Relapse Rate
timeFrame: 12 months
measure: Complete Remission Rate
timeFrame: 12 months
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Cancer Institute (NCI)
state: Maryland
Study officials:
affiliation: National Cancer Institute (NCI)
name: Nirali N Shah, M.D.
role: PRINCIPAL_INVESTIGATOR
References: