Retrospective Study to Evaluate the Impact of Prior Blinatumomab on Subsequent CD19 CAR Outcomes and Evaluation of Other CAR T-cell Related Toxicities
Study Details
Study Description
Brief Summary
PROTOCOL SUMMARY
Title: Retrospective Study to Evaluate the Impact of Prior Blinatumomab on Subsequent CD19 CAR Outcomes and Evaluation of Other CAR T-cell related Toxicities
Study Description: This retrospective protocol focuses on evaluating response following CD19 CAR stratified by prior blinatumomab vs no prior blinatumomab.
Objective: Primary
To evaluate the Response Free Survival (RFS) at 6 months following CD19 CAR stratified by prior blinatumomab vs no prior blinatumomab.
Secondary
To evaluate the RFS at 12 months following CD19 CAR stratified by prior blinatumomab vs no prior blinatumomab.
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 CD19 CAR T-cell product between the dates 01/01/2012 to 12/31/2019.
Description of Sites/Facilities conducting research: This is a limited, multi-site collaboration between the Pediatric Oncology Branch at the National Cancer Institute, Children s Hospital Los Angeles (CHLA), Seattle Children s Hospital (SCH), Colorado Children s Hospital (CHC), Children s Hospital of Philadelphia (CHOP), Johns Hopkins Hospital (JHH) and University of Texas Southwestern Medical Center (UTSWMC).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
PROTOCOL SUMMARY
Title: Retrospective Study to Evaluate the Impact of Prior Blinatumomab on Subsequent CD19 CAR Outcomes and Evaluation of Other CAR T-cell related Toxicities
Study Description: This retrospective protocol focuses on evaluating response following CD19 CAR stratified by prior blinatumomab vs no prior blinatumomab.
Objective: Primary
To evaluate the Response Free Survival (RFS) at 6 months following CD19 CAR stratified by prior blinatumomab vs no prior blinatumomab.
Secondary
To evaluate the RFS at 12 months following CD19 CAR stratified by prior blinatumomab vs no prior blinatumomab.
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 CD19 CAR T-cell product between the dates 01/01/2012 to 12/31/2019.
Description of Sites/Facilities conducting research: This is a limited, multi-site collaboration between the Pediatric Oncology Branch at the National Cancer Institute, Children s Hospital Los Angeles (CHLA), Seattle Children s Hospital (SCH), Colorado Children s Hospital (CHC), Children s Hospital of Philadelphia (CHOP), Johns Hopkins Hospital (JHH) and University of Texas Southwestern Medical Center (UTSWMC).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 1 Retrospective chart review of children and adults with cancer enrolled on immunotherapy treatment protocols |
Outcome Measures
Primary Outcome Measures
- Response free survival [6 months]
To evaluate the RFS at 6 months following CD19 CAR stratified by prior blinatumomab vs no prior blinatumomab.
Secondary Outcome Measures
- Minimal Residual Disease detection [12 months]
To evaluate the MRD negative remission rate following CD19 CAR stratified by prior blinatumomab vs no prior blinatumomab
- Response free survival [12 months]
To evaluate the RFS at 12 months 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
Eligibility Criteria
Criteria
- Subjects will not be recruited for this study; however, subjects records will be selected from treatment protocols who initiated CAR therapy between the dates of 01/01/2012 and 12/31/2019 Subject who opted out of the future use of his/her data will be excluded.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | National Cancer Institute (NCI) | Bethesda | Maryland | United States | 20892 |
Sponsors and Collaborators
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Nirali N Shah, M.D., National Cancer Institute (NCI)
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 10000651
- 000651-C