No registrations found.
ID
Source
Brief title
Health condition
relapsed or refractory ALL
Sponsors and support
Intervention
Outcome measures
Primary outcome
To preliminary estimate the efficacy and safety of Ino in this patient population.
Secondary outcome
Sub-questions that will be answered with the same cohort:
- Any available data on CD22 expression pre and post-InO infusion as a possible escape mechanism
will be collected
- number of patients transplanted prior to InO
- number of patients transplanted post-InO
- VOD/SOS in patients treated with InO
Background summary
Rationale: InO (Besponsa®) was approved by the European Medicines Agency (EMA) on June 2017
for the treatment of adults with relapsed/refractory CD22+ B-cell ALL. However, till now, the pediatrie
experience with InO is extremely limited and only one retrospective cohort of 51 children and young
adults was recently published. Although, in this published cohort, only 3 out of 51 patients were 2-4
years old and no infant patients were reported. The management of drug administration in this
category of patients with very low body weight and low Body Surface Area (BSA) is always
challenging, especially with new agents with potential unknown toxicities. Whether infants tolerate the
drug in a similar fashion compared to older children is also unknown. Collecting data on very young
patients (<3 years old) will therefore be helpful and will also guide clinicians who choose to administer
InO in this category of patients.
Objective: To retrospectively collect data regarding disease characteristics, details of therapy,
children with relapsed or refractory ALL treated with
InO, including the number of pts undergoing SCT post-InO and AESI such as VOD/SOS
Study objective
To retrospectively study Inotuzumab ozogamicin (InO) safety and toxicities in infants and
younger children with relapsed or refractory ALL
To study rates of response (morphologic response and minimal residual disease status) after
therapy with InO
Study design
N/A
Intervention
N/A
Erica Brivio
+31 088 972 9011
e.b.brivio@prinsesmaximacentrum.nl
Erica Brivio
+31 088 972 9011
e.b.brivio@prinsesmaximacentrum.nl
Inclusion criteria
Inclusion criteria
- Age -< 3 years
- Diagnosis of relapsed or refractory ALL
- Patient received at least one dose of Inotuzumab ozogamicin
Exclusion criteria
N/A (patients should fulfill inclusion criteria)
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7937 |
| Other | METC Rotterdam : MEC-2018-1658 (Niet-WMO plichtig) |