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This is an observational, non-interventional, LTFS of investigational Caribou therapies in patients who have participated in a parent study: a prior Caribou-sponsored clinical study, special access program, or an IIT. The objective is to evaluate the long-term safety, through 15 years post infusion, in patients who received IPs in a Caribou-sponsored clinical study, special access program or IIT.
This is an observational, non-interventional, LTFS of investigational Caribou therapies in patients who have participated in a parent study: a prior Caribou-sponsored clinical study, special access program, or an IIT. The objective is to evaluate the long-term safety, through 15 years post infusion, in patients who received IPs in a Caribou-sponsored clinical study, special access program or IIT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients who received IP in a Caribou-sponsored, special access program or IIT and provided informed | consent for the LTFS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caribou-sponsored investigational therapy | Biological | N/A this is an observational study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of targeted NSAEs | Incidence of targeted NSAEs | 15 Years |
| Frequency of targeted NSAEs | Frequency of targeted NSAEs | 15 Years |
| Duration of targeted NSAEs | Duration of targeted NSAEs | 15 Years |
| Outcome of targeted NSAEs | Outcome of targeted NSAEs | 15 Years |
| Incidence of AESIs | Incidence of AESIs | 15 Years |
| Frequency of AESIs | Frequency of AESIs | 15 Years |
| Duration of AESIs | Duration of AESIs | 15 Years |
| Outcome of AESIs | Outcome of AESIs | 15 Years |
| Incidence of targeted SAEs | Incidence of targeted SAEs | 15 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Assessment of overall survival and disease progression as described in the SOA | 15 years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who received IP in a Caribou-sponsored clinical study, special access program, or IIT and provided informed consent for the LTFS
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35233 | United States | ||
| Banner MD Anderson Cancer Center |
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| Frequency of targeted SAEs |
Frequency of targeted SAEs |
| 15 Years |
| Duration of targeted SAEs | Duration of targeted SAEs | 15 Years |
| Outcome of targeted SAEs | Outcome of targeted SAEs | 15 Years |
| Incidence of AEs related to IP leading to death | Incidence of AEs related to IP leading to death | 15 Years |
| Gilbert |
| Arizona |
| 85234 |
| United States |
| Honor Health Research Institute | Scottsdale | Arizona | 85258 | United States |
| University of California Irvine | Irvine | California | 92868 | United States |
| University of California San Diego | La Jolla | California | 92093 | United States |
| University of Colorado | Denver | Colorado | 80045 | United States |
| Colorado Blood Cancer Institute | Denver | Colorado | 80218 | United States |
| University of Miami | Miami | Florida | 33136 | United States |
| AdventHealth Medical Group Blood & Marrow Transplant at Orlando | Orlando | Florida | 32804 | United States |
| Blood & Marrow Transplant Group of Georgia | Atlanta | Georgia | 30342 | United States |
| Augusta University/Georgia Cancer Center | Augusta | Georgia | 30912 | United States |
| University of Iowa Hospitals & Clinics | Iowa City | Iowa | 52242 | United States |
| University of Kentucky | Lexington | Kentucky | 40536 | United States |
| Norton Cancer Institute | Louisville | Kentucky | 40207 | United States |
| Regional Cancer Care Associates - Hackensack | Hackensack | New Jersey | 07601 | United States |
| Atlantic Health System Cancer Care | Morristown | New Jersey | 07960 | United States |
| Weill Cornell Medicine | New York | New York | 10021 | United States |
| Icahn School of Medicine at Mt. Sinai | New York | New York | 10029 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| Levine Cancer Center | Charlotte | North Carolina | 28204 | United States |
| Oncology Hematology Care | Cincinnati | Ohio | 45242 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Sarah Cannon Research Institute - TriStar Health | Nashville | Tennessee | 37203 | United States |
| University of Texas Southwestern | Dallas | Texas | 75235 | United States |
| Baylor Research Institute | Dallas | Texas | 75246 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Huntsman Cancer Institute at the University of Utah | Salt Lake City | Utah | 84112 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 23284 | United States |
| Fred Hutchinson Cancer Center | Seattle | Washington | 98109 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D016393 | Lymphoma, B-Cell |
| D008223 | Lymphoma |
| D019337 | Hematologic Neoplasms |
| D009101 | Multiple Myeloma |
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D009371 | Neoplasms by Site |
| D006402 | Hematologic Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
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