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

Pfizer

Status: Active, not recruiting

Conditions: Acute Lymphocytic Leukemia

Study type: Observational

Funder types: Industry

Identifiers

NCT06476665

NCT06476665 (Registry Identifier)

B1931035

Details and patient eligibility

About

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.

Enrollment: 7 patients

Sex: All

Ages: Under 17 years old

Volunteers: No Healthy Volunteers

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