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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2024-06344 | Registry Identifier | National Cancer Institute: Clinical Trials Reporting Program |
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| Name | Class |
|---|---|
| The Pediatric Oncology Experimental Therapeutics Investigators' Consortium | OTHER |
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To use a consistent and standardized platform to retrospectively and prospectively study children and young adults with B cell malignancies receiving Immunotherapy, blinatumomab and/or inotuzumab ozogamicin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A (Retrospective data) | Participants who have undergone standard of care tisagenlecleucel therapy, Participants will received a questionnaire study using patient reported outcomes. |
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| Arm B (Prospective data) | Patients enrolled in ARM B will be asked to participate in the biological sample collection. Participants will received a questionnaire |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaire for patients receiving therapy | Other | Questionnaires will be given (at baseline, 1, 3, 6, and 12 months post CAR infusion) including baseline demographics, individual/family and neighborhood socioeconomic data, measures of household material hardship (housing and transportation insecurity, household energy and food insecurity), barriers to care at the CAR T cell institution, as well as patient reported outcomes following Kymriah infusion. |
| Measure | Description | Time Frame |
|---|---|---|
| WECARE-Survey | Participant will take part in a one-time questionnaire to address CAR specific questions. WECARE survey, consists of questions used to identify seven unmet material needs (education, employment, food security, housing, childcare, household heat, language) | at baseline |
| Retrospective WECARE Survey | Surveys will be administered at a single time point post-CAR | up to 12 months post infusion |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival (OS) | Overall survival was the duration from the start of study treatment to death. | at baseline up to 12 months post infusion |
| event-free-survival (EFS) | probability of recurrence or progression of in patients |
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Inclusion Criteria (Arm A)
* Disease Status - B cell precursor acute lymphoblastic leukemia (ALL) or B cell lymphoma
Who either:
OR
Previously undergone standard of care immunotherapy with FDA approved therapies, such as Kymriahâ„¢ (CTL019, tisagenlecleucel), blinatumomab or
Inclusion Criteria (Arm B)
Disease Status - B cell precursor acute lymphoblastic leukemia (ALL) or B cell lymphoma
Age: Greater than or equal to 0 year of age and less than or equal to 26 years of age
Patients who are either:
Ability to give informed consent. All subjects ≥ 18 years of age must be able to give informed consent or have legal authorized representative (LAR) (i.e. parent or guardian) to consent, if not in capacity to give consent independently. For subjects <18 years old their LAR must give informed consent. Pediatric subjects will be included in age appropriate discussion and written assent will be obtained for those > 7 years of age, when appropriate, according to institutional procedures.
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Both Arm A and Arm B, includes retrospective and prospective data collection for patients experiencing refractory disease or first relapse, who have not received immunotherapy and are not yet being considered for immunotherapy. Retrospective data collection will parallel Arm A and patients will not require consent or assent. Prospective data collection will parallel Arm B and will require patient consent and assent as relevant
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Khanh Nguyen | Contact | (650) 721-2372 | khanhpn@stanford.edu |
| Name | Affiliation | Role |
|---|---|---|
| Kara Davis, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner University Medical Center - Tucson | Recruiting | Tucson | Arizona | 85719 | United States |
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| at baseline up to 12 months post infusion |
| duration of remission (DOR) | at baseline up to 12 months post infusion |
| City of Hope Comprehensive Cancer Center | Recruiting | Duarte | California | 91010 | United States |
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| Stanford University | Recruiting | Palo Alto | California | 94305 | United States |
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| UCSF (Benioff Children's) | Recruiting | San Francisco | California | 94115 | United States |
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| Nemours Children's Hospital | Recruiting | New Castle | Delaware | 19803 | United States |
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| University of Florida Health Science Center - Gainesville | Recruiting | Gainesville | Florida | 32610 | United States |
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| Johns Hopkins All Children's Hospital | Recruiting | St. Petersburg | Florida | 33701 | United States |
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| Ann & Robert H. Lurie Children's Hospital of Chicago | Recruiting | Chicago | Illinois | 60611 | United States |
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| Johns Hopkins University/Sidney Kimmel Cancer Center | Recruiting | Baltimore | Maryland | 21231 | United States |
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| Dana-Farber Cancer Institute | Recruiting | Boston | Massachusetts | 02215 | United States |
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| Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital | Recruiting | Grand Rapids | Michigan | 49503 | United States |
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| St. Louis Children's (Washington University) | Recruiting | St Louis | Missouri | 63110 | United States |
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| Children's Hospital at Montefiore | Recruiting | The Bronx | New York | 10467 | United States |
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| Atrium Health Levine Cancer Institute | Recruiting | Charlotte | North Carolina | 28262 | United States |
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| Cincinnati Children's Hospital Medical Center | Recruiting | Cincinnati | Ohio | 45229 | United States |
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| OHSU Knight Cancer Institute | Recruiting | Portland | Oregon | 97239 | United States |
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| Children's Hospital of Pittsburgh of UPMC | Recruiting | Pittsburgh | Pennsylvania | 15224 | United States |
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| UT Southwestern/Simmons Cancer Center-Dallas | Recruiting | Dallas | Texas | 75235 | United States |
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| Cook Children's Medical Center | Recruiting | Fort Worth | Texas | 76104 | United States |
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| Saint Jude Children's Research Hospital | Recruiting | Fairfax | Virginia | 22203 | United States |
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| Seattle Children's Hospital | Recruiting | Seattle | Washington | 98105 | United States |
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| Medical College of Wisconsin | Recruiting | Milwaukee | Wisconsin | 53226 | United States |
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| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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