Acute Lymphocytic LeukemiaNCT06476665
A Study to Learn About the Safety of BESPONSA Injection in Pediatric Patients With Acute Lymphocytic Leukemia.
An observational study of Acute Lymphocytic Leukemia, run by Pfizer at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 17 years
- Conditions the study is for
- Acute Lymphocytic Leukemia
- How many people
- 12 participants
- Where
- 1 siteJapan
- Study dates
- 7 Nov 2024to 22 Jun 2029
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric patients with relapsed or refractory CD22-positive ALL receiving BESPONSA
Who may be able to join
- Patients with relapsed or refractory CD22-positive ALL
- Patients who have never used BESPONSA before
- Patients aged <18 years at the start of treatment with BESPONSA
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: BESPONSA INJECTION 1MG SPECIAL INVESTIGATION (PEDIATRIC INVESTIGATION)
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.
Read more
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.
- Conditions
- Acute Lymphocytic Leukemia
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of adverse events
Measured: Up to 28 days after the last administration
Risk factors related to the onset of venoocclusive liver disease/sinusoidal obstruction syndrome
Measured: Up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start7 Nov 2024
- Primary completion22 Jun 2029 (estimated)
- Study completion22 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphocytic LeukemiaStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06476665
- Sponsor's protocol ID
- B1931035
- Other IDs
- NCT06476665
- Status last verified
- Sep 2026
- First submitted
- 20 Jun 2024
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: 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.