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
Bron
Verkorte titel
Aandoening
relapsed or refractory ALL
Ondersteuning
Onderzoeksproduct en/of interventie
Geen registraties gevonden.
Uitkomstmaten
Primaire uitkomstmaten
To preliminary estimate the efficacy and safety of Ino in this patient population.
Achtergrond van het onderzoek
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
Doel van het onderzoek
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
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
N/A
Publiek
Erica Brivio
+31 088 972 9011
e.b.brivio@prinsesmaximacentrum.nl
Wetenschappelijk
Erica Brivio
+31 088 972 9011
e.b.brivio@prinsesmaximacentrum.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Inclusion criteria
- Age -< 3 years
- Diagnosis of relapsed or refractory ALL
- Patient received at least one dose of Inotuzumab ozogamicin
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
N/A (patients should fulfill inclusion criteria)
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL7937 |
Ander register | METC Rotterdam : MEC-2018-1658 (Niet-WMO plichtig) |