A retrospective study on compassionate use of InotuzumabOzogamicin in infants and younger children with relapsed orrefractory acute lymphoblastic leukemia (ALL)
Recruiting
- Conditions
- relapsed or refractory A
- Registration Number
- NL-OMON29610
- Lead Sponsor
- Prinses Maxima Centrum voor kinderoncologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 20
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)
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To preliminary estimate the efficacy and safety of Ino in this patient population.
- Secondary Outcome Measures
Name Time Method Sub-questions that will be answered with the same cohort:<br>- Any available data on CD22 expression pre and post-InO infusion as a possible escape mechanism<br>will be collected<br>- number of patients transplanted prior to InO<br>- number of patients transplanted post-InO<br>- VOD/SOS in patients treated with InO