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| ID | Type | Description | Link |
|---|---|---|---|
| NCT06476665 | Registry Identifier | ClinicalTrials.gov |
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The purpose of this study is to learn about the safety of BESPONSA for pediatric patients. .
BESPONSA is approved for treatment of relapsed or refractory CD22-positive acute lymphocytic leukemia for pediatric patients. A type of leukemia (blood cancer) that comes on quickly and is fast growing. In acute lymphocytic leukemia, there are too many lymphoblasts (early-stage white blood cells) in the blood and bone marrow. Also called ALL.
The registration criteria for this study are:
All patients in this study will receive BESPONSA according to the prescriptions.
Patients will be followed up as follow
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| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of adverse events | Up to 28 days after the last administration | |
| Risk factors related to the onset of venoocclusive liver disease/sinusoidal obstruction syndrome | Up to 52 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Pediatric patients with relapsed or refractory CD22-positive ALL receiving BESPONSA
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer | Tokyo | Japan |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |