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NCT06476665 | NOT YET RECRUITING | Acute Lymphocytic Leukemia


A Study to Learn About the Safety of BESPONSA Injection in Pediatric Patients With Acute Lymphocytic Leukemia.
Sponsor:

Pfizer

Brief Summary:

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: * Never used BESPONSA before * \<18 years at the start of treatment with BESPONSA All patients in this study will receive BESPONSA according to the prescriptions. Patients will be followed up as follow. * Treatment phase: From the day of treatment initiation (Day 1) to Day 28 post-treatment to collect information on safety (e.g., adverse events). * Follow-up phase: From Day 29 post-treatment to Week 52 to collect information on VOD/SOS.

Condition or disease

Acute Lymphocytic Leukemia

Study Type : OBSERVATIONAL
Estimated Enrollment : 1 participants
Official Title : BESPONSA INJECTION 1MG SPECIAL INVESTIGATION (PEDIATRIC INVESTIGATION)
Actual Study Start Date : 2024-12-31
Estimated Primary Completion Date : 2029-06-22
Estimated Study Completion Date : 2029-06-22

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 0 Years to 17 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 1. Patients with relapsed or refractory CD22-positive ALL
  • 2. Patients who have never used BESPONSA before
  • 3. Patients aged \<18 years at the start of treatment with BESPONSA
Exclusion Criteria
  • * None

A Study to Learn About the Safety of BESPONSA Injection in Pediatric Patients With Acute Lymphocytic Leukemia.

Location Details

NCT06476665


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