CAR-Multicenter Analysis (CAR-MA): Retrospective Study to Characterize CAR T-cell Outcomes and Related Toxicities in Children and Young Adults With B-ALL
- Conditions
- Leukemia, Acute LymphoblasticLymphoblastic Leukemia, Acute, Childhood
- Registration Number
- NCT05440409
- Lead Sponsor
- National Cancer Institute (NCI)
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 57
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response free survival 6 months To evaluate the RFS at 6 months following CD19 CAR stratified by prior blinatumomab vs no prior blinatumomab.
Outcome evaluation 12 months To retrospectively evaluate outcomes following CAR T-cell therapy across children and young adults with B-ALL
- Secondary Outcome Measures
Name Time Method Response free survival 12 months To evaluate the RFS at 12 months following CD19 CAR stratified by prior blinatumomab vs no prior blinatumomab
Minimal Residual Disease detection 12 months To evaluate the MRD negative remission rate following CD19 CAR stratified by prior blinatumomab vs no prior blinatumomab
Relapse Rate 12 months To evaluate the incidence of CD19 negative versus CD19 positive relapse following CD19 CAR stratified by prior blinatumomab vs no prior blinatumomab
Complete Remission Rate 12 months To evaluate the CR rate following CD19 CAR stratified by prior blinatumomab vs no prior blinatumomab
Trial Locations
- Locations (1)
National Cancer Institute (NCI)
🇺🇸Bethesda, Maryland, United States