A retrospective study on compassionate use of Inotuzumab Ozogamicin in infants and younger children with relapsed or refractory acute lymphoblastic leukemia (ALL)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON29610

Enrollment

Registered

2019-08-05

Start date

2018-12-20

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

relapsed or refractory ALL

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion criteria - Age -< 3 years - Diagnosis of relapsed or refractory ALL - Patient received at least one dose of Inotuzumab ozogamicin

Exclusion criteria

Exclusion criteria: N/A (patients should fulfill inclusion criteria)

Design outcomes

Primary

Measure	Time frame
To preliminary estimate the efficacy and safety of Ino in this patient population.	—

Secondary

Measure	Time frame
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	—

Contacts

Public ContactErica Brivio

Prinses Maxima Centrum voor kinderoncologie

e.b.brivio@prinsesmaximacentrum.nl+31 088 972 9011

Outcome results