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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2024-06836 | Registry Identifier | NCI Clinical Trial Registration Program |
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| Name | Class |
|---|---|
| Rally Foundation for Childhood Cancer Research | OTHER |
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This study is being done to learn more about the short-term and long-term side effects of CAR-T cell therapy. Specifically, researchers want to know how often patients get infections, have delays in recovering blood cell counts and/or have damage to the nervous system.
Primary Objectives
Secondary Objectives
Participants will have an assessment of preexisting morbidity and potential risk factors, collection of specimens for banking, scheduled late effects monitoring, laboratory analysis, and screening studies. Data and biospecimens will be collected at 3 months, 6 months, 1 year and 2 years after CAR T cell infusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| B cell acute lymphoblastic leukemia (B cell acute lymphoblastic leukemia (B-ALL) ) cohort | B-ALL participants who have received initial CAR T cell therapy within the last 1-3 months. | ||
| Other hematologic malignancy | Other hematologic malignancy participants who have received initial CAR T cell therapy within the last 1-3 months. | ||
| Solid tumor (ST) | ST participants who have received initial CAR T cell therapy within the last 1-3 months. |
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| Measure | Description | Time Frame |
|---|---|---|
| Presence of bone marrow dysfunction (BMD) | Among patients in remission or without bone marrow involvement of disease in the B-ALL cohort, we will summarize the rates of prevalent BMD at 3- and 6-months post-infusion and estimate the cumulative incidence of new BMD and BMD recovery for patients with prevalent BMD at 3- and 6-months. | Within 6 months post CAR T-cell therapy |
| Occurrence of clinically significant infections | The infection density of clinically significant infections in 3-6 months will be summarized in the B-ALL cohort. | Within 6 months post CAR T-cell therapy |
| Presence of persistent ICANS | We will summarize the rates of persistent ICANS at 3- and 6-months post-infusion and estimate the cumulative incidence and timing of new ICANS and ICANS recovery for patients with persistent ICANS at 3- and 6-months in the B-ALL cohort. | Within 6 months post CAR T-cell therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of bone marrow dysfunction (BMD) | Among patients in remission or without bone marrow involvement of disease in the B-ALL cohort, we will summarize the rates of prevalent BMD at 12- and 24-months post-infusion and estimate the cumulative incidence of new BMD and BMD recovery for patients with prevalent BMD at 12- and 24-months. Analyses will be replicated in the other hematologic malignancies and solid tumor cohorts. |
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Inclusion Criteria:
Participants must have received an initial systemically-administered CAR T cell infusion within the last 1-3 months (+/- 14 days).
Age ≤ 30 years at CAR T cell infusion.
Exclusion Criteria:
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Participants who have received CAR T cell therapy
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rebecca Epperly, MD | Contact | 888-226-4343 | referralinfo@stjude.org |
| Name | Affiliation | Role |
|---|---|---|
| Rebecca Epperly, MD | St. Jude Children's Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Childrens Hospital of Colorado | Recruiting | Aurora | Colorado | 80045 | United States |
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| Label | URL |
|---|---|
| St. Jude Children's Research Hospital | View source |
| Clinical Trials Open at St. Jude | View source |
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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blood and bone marrow
| Within 24 months post CAR T-cell therapy |
| Severity of BMD | The highest severity BMD for each patient will be recorded. The severity of BMD in the B-ALL cohort will be described using descriptive statistics. Analyses will be replicated in the other hematologic malignancies and solid tumor cohorts. | Within 24 months post CAR T-cell therapy |
| Occurrence of clinically significant infections | The infection density of clinically significant infections within 24 months will be summarized in the B-ALL cohort. Analyses will be replicated in the other hematologic malignancies and solid tumor cohorts. | Within 24 months post CAR T-cell therapy |
| Time to the earliest clinically significant infection | The time from 3 months post-infusion to the first clinically significant post-infusion within 24 months post-infusion will be summarized in the B-ALL cohort. The cumulative incidence of the first clinically significant infection post-infusion within 24 months will be estimated in B-ALL cohort. Analyses will be replicated in the other hematologic malignancies and solid tumor cohorts. | Within 24 months post CAR T-cell therapy |
| Severity of clinically significant infections | The highest severity among all clinically significant infections for each patient will be summarized. The severity of clinically significant infections in the B-ALL cohort will be described. Analyses will be replicated in the other hematologic malignancies and solid tumor cohorts. | Within 24 months post CAR T-cell therapy |
| Presence of persistent ICANS | We will summarize the rates of persistent ICANS at 12- and 24-months post-infusion and estimate the cumulative incidence and timing of new ICANS and ICANS recovery for patients with persistent ICANS at 12- and 24-months in B-ALL cohort. Analyses will be replicated in the other hematologic malignancies and solid tumor cohorts. | Within 24 months post CAR T-cell therapy |
| Severity of persistent ICANS | The highest severity of ICANS for each patient will be recorded. The severity of ICANS in the B-ALL cohort will be described using descriptive statistics. Analyses will be replicated in the other hematologic malignancies and solid tumor cohorts. | Within 24 months post CAR T-cell therapy |
| Children's Hospital of Philadelphia | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| St. Jude Children's Research Hospital | Recruiting | Memphis | Tennessee | 38105 | United States |
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| Primary Children's Hospital | Recruiting | Salt Lake City | Utah | 84113 | United States |
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| Seattle Childrens Hospital | Recruiting | Seattle | Washington | 98105 | United States |
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| Children's Hospital of Wisconsin. | Recruiting | Milwaukee | Wisconsin | 53226 | United States |
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